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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01534234




Registration number
NCT01534234
Ethics application status
Date submitted
27/09/2011
Date registered
16/02/2012
Date last updated
11/01/2019

Titles & IDs
Public title
Clinical Trial of the SonRtip Lead and Automatic AV-VV Optimization Algorithm in the PARADYM RF SonR CRT-D
Scientific title
Clinical Trial of the SonRtip Lead and Automatic AV-VV Optimization Algorithm in the PARADYM RF SonR CRT-D
Secondary ID [1] 0 0
ITSY06 - RESPOND CRT
Universal Trial Number (UTN)
Trial acronym
RESPOND-CRT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure NYHA Class III and Ambulatory IV 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Devices - PARADYM RF SONR
Treatment: Devices - PARADYM RF SONR

Experimental: SonR group - SonR CRT Optimization

Active comparator: ECHO group - Echocardiographic Optimization


Treatment: Devices: PARADYM RF SONR
SonR CRT Optimization

Treatment: Devices: PARADYM RF SONR
Echocardiography Optimization
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluation of SonR CRT Optimization Effectiveness in terms of proportion of responders at 12 months. The investigational(SonR)and control groups(ECHO)will be compared in a non-inferiority context employing a clinically meaningful difference of 10%.
Assessment method [1] 0 0
The analysis will be done on all patients implanted with the entire system who have been followed out to 12 months. The patients will be classified as improved, unchanged or worsened based on composite criteria(death/heart failure (HF) events,New York Heart association(NYHA) class), Quality of life (QOL). In the event that the non-inferiority test is met, a test of superiority will be conducted comparing the treatment and control groups.
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
Evaluation of Lead Safety: Acute SonRTipLead Complication-Free Rate (at 3 months)
Assessment method [2] 0 0
SonRtip acute lead-related complication-free rate is defined as the proportion of patients not experiencing any complication related to the SonRtip lead within 3 months post-implant, relative to the total number of patients implanted with the lead.All patients who are successfully implanted with SonRtip lead will be included.
Timepoint [2] 0 0
3 months
Primary outcome [3] 0 0
Evaluation of Lead Safety: Chronic SonRTipLead Complication-Free Rate (from 3 months to 12 months)
Assessment method [3] 0 0
SonRtip lead-related complication-free rate is defined as the proportion of patients not experiencing any complication related to the SonRtip lead from 3 to 12 months post-implant.All patients who are successfully implanted with SonRtip lead will be included.
Timepoint [3] 0 0
12 months
Secondary outcome [1] 0 0
Evaluation of CRT effectiveness and CRT Safety: evaluation of Mortality and HF hospitalizations at 12 months
Assessment method [1] 0 0
This endpoint will compare treatment arms in a non-inferiority hypothesis test of the proportion of subjects that either died from any cause, or were hospitalized for heart failure
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Evaluation of CRT effectiveness and CRT therapy: Proportion of patients worsened at 12 months
Assessment method [2] 0 0
This endpoint will compare treatment arms in a non-inferiority hypothesis test of the proportion of subjects classified as worsened, in order to evaluate the potential detrimental effects of the optimization method
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
SonR tip lead pacing threshold
Assessment method [3] 0 0
For all patients implanted with the SonRtip lead.
Timepoint [3] 0 0
24 months
Secondary outcome [4] 0 0
SonR tip lead sensing threshold
Assessment method [4] 0 0
For all patients implanted with the SonRtip lead.
Timepoint [4] 0 0
24 months
Secondary outcome [5] 0 0
SonR tip lead pacing impedance
Assessment method [5] 0 0
For all patients implanted with the SonRtip lead.
Timepoint [5] 0 0
24 months
Secondary outcome [6] 0 0
Evaluation of CRT effectiveness and CRT and System Safety: Report deaths for any cause
Assessment method [6] 0 0
The report of the deaths occurred consists of the percentage of dead patients, the causes of death, the time to death, the survival curves.
Timepoint [6] 0 0
24 months
Secondary outcome [7] 0 0
Report Heart Failure-related events to assess CRT effectiveness
Assessment method [7] 0 0
For all patients implanted it will be reported the percentage of patients with events, number of events for patients, event type, time to first occurence, survival curves)
Timepoint [7] 0 0
24 months
Secondary outcome [8] 0 0
Report Quality of life (QOL) improvement to assess CRT effectiveness (percentage of patients with improvements in QOL)
Assessment method [8] 0 0
In all patients implanted the evaluation of the Quality of Life Score will consist of reporting the percentage of patients who showed improvement in their KCCQ Score at each follow-up post-implant
Timepoint [8] 0 0
24 months
Secondary outcome [9] 0 0
Report NYHA class improvement to assess CRT effectiveness (the percentage of patients with improved in NYHA class)
Assessment method [9] 0 0
In all patients implanted the evaluation of the NYHA Classification will consist of reporting the percentage of patients who improved at least one NYHA class at each follow-up post-implant
Timepoint [9] 0 0
24 months
Secondary outcome [10] 0 0
Evaluation of CRT effectiveness: Report echocardiographic parameters trend at M12
Assessment method [10] 0 0
The intra-patient variations of the echocardiographic parameters measured at M12 as compared to those measured at baseline. The echo measures will be validated by an independent and blinded core lab
Timepoint [10] 0 0
12 months
Secondary outcome [11] 0 0
Evaluation of SonR CRT Optimization Effectiveness - Superiority by assessment the proportion of responder patients in SonR group
Assessment method [11] 0 0
The analysis will be done on all patients implanted with the entire system. The patients will be classified as improved, unchanged or worsened based on composite criteria(death/heart failure events,NYHA class, Quality of life (QOL).
Timepoint [11] 0 0
18/24 months
Secondary outcome [12] 0 0
Evaluation of the time spent for CRT optimization by the physician on optimization in each group (sonR and ECHO)
Assessment method [12] 0 0
The amount of time (mean, median, standard deviation, minimum, maximum)in each group will be evaluated in all patients implanted
Timepoint [12] 0 0
24 months
Secondary outcome [13] 0 0
Evaluation of the Number of re-optimizations performed in both groups (SonR and ECHO)
Assessment method [13] 0 0
In all patients implanted will be evaluated the number of re-optimizations performed (mean, median, standard deviation, minimum, maximum) in each group (study and control).
Timepoint [13] 0 0
24 months
Secondary outcome [14] 0 0
Report Adverse Events for both group to assess CRT effectiveness / System Safety
Assessment method [14] 0 0
For all patients enrolled all Adverse Events will be reported.
Timepoint [14] 0 0
24 months

Eligibility
Key inclusion criteria
1. Patient eligible with class I and IIa indication for implantation of a CRT-D device according to current available guidelines ;
2. Modere,Severe HF (NYHA Class III or ambulatory IV)
3. LVEF = 35 %
4. LBBB: QRS = 120 ms ; non-LBBB : QRS = 150 ms
5. On a stable, optimal drug regimen
6. Patient is in sinus rhythm at the time of enrollment;
7. Signed and dated informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Ventricular tachyarrhythmia of transient or reversible causes such as acute myocardial infarction, digitalis intoxication, drowning, electrocution, electrolyte imbalance, hypoxia or sepsis, uncorrected at the time of the enrolment;
2. Incessant ventricular tachyarrhythmia;
3. Unstable angina, or acute MI, CABG, or PTCA within the past 4 weeks;
4. Correctable valvular disease that is the primary cause of heart failure;
5. Recent CVA or TIA (within the previous 3 months);
6. Persistent or permanent atrial arrhythmias (or cardioversion for atrial fibrillation) within the past month;
7. Post heart transplant (patients who are waiting for a heart transplant are allowed in the study);
8. Renal failure (GFR<15 ml/min/1.73m2) or on dialysis
9. Previous implant with a CRT/CRT-D device;
10. Concurrent implant with another pacemaker or ICD (previously implanted pacemaker or ICD devices or RA leads should be removed prior to implant with the Paradym RF SONR CRT-D);
11. Already included in another clinical study that could confound the results of this study;
12. Life expectancy less than 1 year;
13. Inability to understand the purpose of the study or to understand and complete the QOL questionnaire;
14. Unavailability for scheduled follow-up or refusal to cooperate;
15. Sensitivity to 1 mg dexamethasone sodium phosphate (DSP)
16. Age of less than 18 years;
17. Pregnancy
18. Drug addiction or abuse
19. Under guardianship

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2019
Actual
Sample size
Target
Accrual to date
Final
1039
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [2] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
4104 - Brisbane
Recruitment postcode(s) [2] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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Arizona
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California
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Florida
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Georgia
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Illinois
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Louisiana
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Massachusetts
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Michigan
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New Jersey
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New York
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North Carolina
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Ohio
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Oklahoma
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Pennsylvania
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South Carolina
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Texas
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Austria
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Feldkirch
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Austria
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Innsbruck
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Austria
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Wien
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France
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Brest
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France
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Grenoble
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France
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Lille
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France
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Marseille
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France
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Massy
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France
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Nantes
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France
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Paris
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France
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Pessac
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France
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Poitiers
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France
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Rouen
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France
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Saint Etienne
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Toulouse
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Tours
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France
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Vandoeuvre Les Nancy
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France
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Villeurbanne
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Germany
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Bad Bevensen
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Bad Nauheim
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Bad Oeynhausen
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Berlin
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Bonn
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Coburg
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Frankfurt
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Freiburg
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Hamburg
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Hannover
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Kiel
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Ludwigshafen
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Magdeburg
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München
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Münster
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Reinbek
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Alessandria
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Ancona
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Caserta
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Catania
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Cesena
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Cuneo
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Mirano
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Pisa
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Torino
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Treviso
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Italy
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Trieste
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Udine
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Netherlands
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Doetinchem
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Rotterdam
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Schiedam
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Tilburg
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Veghel
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Zwolle
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Portugal
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Amadora
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Portugal
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Carnaxide
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Portugal
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Lisboa
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Portugal
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Porto
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Portugal
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Vila Nova de Gaia
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Slovenia
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Ljubljana
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Spain
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Alicante
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Spain
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Badalona
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Spain
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Barcelona
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Spain
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Granada
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Spain
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Madrid
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Spain
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Majadahonda
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Spain
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Malaga
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Spain
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Oviedo
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Spain
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San Sebastian
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Spain
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Santander
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Spain
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Sevilla
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Spain
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Valencia
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Spain
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Vigo
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Switzerland
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Lausanne
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Switzerland
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Lugano
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United Kingdom
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Birmingham
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United Kingdom
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Cambridge
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United Kingdom
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Chertsey
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United Kingdom
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Cottingham
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United Kingdom
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Leeds
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United Kingdom
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Leicester
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United Kingdom
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
MicroPort CRM
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Sorin CRM
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Josep Brugada
Address 0 0
Hospital Clinic of Barcelona
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01534234