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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02656537




Registration number
NCT02656537
Ethics application status
Date submitted
16/11/2015
Date registered
15/01/2016
Date last updated
1/02/2019

Titles & IDs
Public title
EnSite™ HD Grid Catheter AF/AT Mapping Study
Scientific title
EnSite™ HD Grid Catheter Mapping System for Advanced High Density Three-Dimensional Mapping in Non-Paroxysmal Atrial Fibrillation and Atrial Tachycardia
Secondary ID [1] 0 0
CRD772
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-paroxysmal Atrial Fibrillation 0 0
Left Atrial Tachycardia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - EnSite™ HD Grid Catheter mapping system

Experimental: EnSite™ HD Grid Catheter AF/AT Mapping -


Treatment: Devices: EnSite™ HD Grid Catheter mapping system
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of subjects with adverse events associated with the use of the EnSite™ HD (High-Density)Grid Catheter mapping system.
Timepoint [1] 0 0
Within 48 hours from Procedure
Primary outcome [2] 0 0
Number of subjects with the electrophysiological characteristics of non-paroxysmal AF and left AT pre-catheter ablation studied using the EnSite™ HD Grid Catheter mapping system.
Timepoint [2] 0 0
During Procedure
Primary outcome [3] 0 0
Catheter performance during the mapping portion of the procedure
Timepoint [3] 0 0
During Procedure

Eligibility
Key inclusion criteria
1. Presence of non-paroxysmal atrial fibrillation (AF) or left atrial tachycardia (AT)
referred for catheter ablation

2. Age of 18 years of age or older at time of Enrollment

3. On continuous anticoagulation (INR 2-3) for >4 weeks prior to the ablation

4. Able and willing to provide written informed consent to participate in this clinical
investigation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Secondary atrial fibrillation (AF)

2. Presence of a prosthetic valve(s) or hemodynamically significant valvular heart
disease as determined by Study Investigator

3. Active systemic infection (e.g. sepsis)

4. Presence of left atrial thrombus (i.e., positive TEE) or myxoma, or interatrial baffle
or patch via the transseptal approach

5. Contraindication to systemic anticoagulation (i.e., heparin, warfarin, or a direct
thrombin inhibitor)

6. History of cerebrovascular accidents (Stroke, TIA)

7. Previous myocardial infarction, unstable angina pectoris or coronary artery by-pass
<180 days at Enrollment or cardiovascular intervention expected in the 180 days
post-Enrollment

8. Left atrial size >55mm

9. NYHA (New York Heart Association Classification) functional class III or IV heart
failure

10. Left ventricular ejection fraction <35%

11. Uncontrolled Hyperthyroidism

12. Pregnant or of childbearing potential and not using adequate contraceptive methods or
nursing

13. Participating in another clinical investigation that may confound the results of this
clinical investigation

14. Life expectancy less than 12 months, as determined by Study Investigator

15. Severe clinical condition (e.g. active carcinoma) that, in the opinion of the Study
Investigator, excludes the participation in the study

Study design
Purpose of the study
Diagnosis
Allocation to intervention
N/A
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2018
Sample size
Target
Accrual to date
Final
82
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Ashford Hospital - Ashford
Recruitment hospital [3] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
5035 - Ashford
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Pessac
Country [2] 0 0
Germany
State/province [2] 0 0
Dresden
Country [3] 0 0
Hong Kong
State/province [3] 0 0
Hong Kong
Country [4] 0 0
Italy
State/province [4] 0 0
Milan

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
In this clinical investigation, the safety, feasibility and performance of the novel EnSite™
HD Grid Catheter mapping system for advanced high-density three-dimensional mapping will be
studied in patients undergoing catheter ablation procedures for the treatment of
non-paroxysmal atrial fibrillation (AF) or left atrial tachycardia (AT).
Trial website
https://clinicaltrials.gov/ct2/show/NCT02656537
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Carlo Pappone, MD, PhD
Address 0 0
San Donato Hospital, Italy
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries