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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02205359




Registration number
NCT02205359
Ethics application status
Date submitted
18/07/2014
Date registered
31/07/2014
Date last updated
29/11/2023

Titles & IDs
Public title
AdaptResponse Clinical Trial
Scientific title
AdaptResponse Clinical Trial
Secondary ID [1] 0 0
AdaptResponse
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure With Left Bundle Branch Block 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 - aCRT ON
Treatment: Devices - aCRT OFF

Experimental: aCRT ON - The aCRT algorithm has been developed to provide RV-synchronized LV pacing when intrinsic AV conduction is normal or BiV pacing otherwise

Active comparator: aCRT OFF - Standard CRT


Treatment: Devices: aCRT ON
CRT device with AdaptivCRT enabled (AdaptivBiV and LV)

Treatment: Devices: aCRT OFF
CRT device with AdaptivCRT disabled
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Combined Endpoint of All-cause Mortality and Intervention for Heart Failure Decompensation
Timepoint [1] 0 0
from subject randomization until the first occurrence of death or intervention for heart failure decompensation, median follow-up 4.9 years (max. follow-up 8.1 years)
Secondary outcome [1] 0 0
All-cause Mortality
Timepoint [1] 0 0
from subject randomization until the occurrence of death, median follow-up 4.9 years (max. follow-up 8.1 years)
Secondary outcome [2] 0 0
Percent of Patients With Interventions for Heart Failure Decompensation
Timepoint [2] 0 0
from subject randomization until the first occurrence of intervention for heart failure decompensation, median follow-up 4.9 years (max. follow-up 8.1 years)
Secondary outcome [3] 0 0
Clinical Composite Score
Timepoint [3] 0 0
CCS at 6 month post randomization
Secondary outcome [4] 0 0
Atrial Fibrillation
Timepoint [4] 0 0
from subject randomization until the first occurrence of atrial fibrillation lasting >6 hours in one day, median follow-up 4.9 years (max. follow-up 8.1 years)
Secondary outcome [5] 0 0
Change in Quality of Life Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Timepoint [5] 0 0
from baseline to 24M follow up
Secondary outcome [6] 0 0
Change in Quality of Life Measured by the EQ-5D
Timepoint [6] 0 0
from baseline to 24M follow up
Secondary outcome [7] 0 0
All-cause Re-admissions Within 30 Days After a Heart Failure Admission Per 100 Patient Years
Timepoint [7] 0 0
from subject randomization until study exit, median follow-up 4.9 years (max. follow-up 8.1 years)

Eligibility
Key inclusion criteria
* Subject is willing to sign and date the study Patient Informed Consent Form.
* Subject is indicated for a CRT device according to local guidelines.
* Sinus Rhythm at time of enrollment
* Complete Left Bundle Branch Block (LBBB) as documented on an ECG (within 30 days prior to enrollment). Strauss Criteria used for LBBB.
* Intrinsic, normal AV conduction as documented on an ECG by a PR interval less than or equal to 200ms (within 30 days prior to enrollment).
* Left ventricular ejection fraction less than or equal to 35% (documented within 180 days prior to enrollment).
* NYHA class II, III or IV (documented within 30 days prior to enrollment) despite optimal medical therapy. Optimal medical therapy is defined as maximal tolerated dose of Beta-blockers and a therapeutic dose of ACE-I, ARB or Aldosterone Antagonist.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subject is less than 18 years of age (or has not reached minimum age per local law).
* Subject is not expected to remain available for at least 2 years of follow-up visits.
* Subject has permanent atrial arrhythmias for which pharmacological therapy and/or cardioversion have been unsuccessful or have not been attempted
* Subject is, or previously has been, receiving cardiac resynchronization therapy.
* Subject is currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager.
* Subject has unstable angina, or experienced an acute myocardial infarction (MI) or received coronary artery revascularization (CABG) or coronary angioplasty (PTCA) within 30 days prior to enrollment.
* Subject has a mechanical tricuspid heart valve or is scheduled to undergo valve repair or valve replacement during the course of the study.
* Subject is post heart transplant (subjects on the heart transplant list for the first time are not excluded).
* Subject has a limited life expectancy due to non-cardiac causes that would not allow completion of the study.
* Subject is pregnant (if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to device implant).
* Subject meets any exclusion criteria required by local law.

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


Intervention assignment
Parallel
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
1/08/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/11/2022
Sample size
Target
Accrual to date
Final
3797
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [3] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [4] 0 0
Saint Vincent's Hospital (Sydney) - Sydney
Recruitment postcode(s) [1] 0 0
- New Lambton
Recruitment postcode(s) [2] 0 0
- Heidelberg
Recruitment postcode(s) [3] 0 0
- Murdoch
Recruitment postcode(s) [4] 0 0
- Sydney
Recruitment outside Australia
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United States of America
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Arizona
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Arkansas
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California
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Colorado
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Connecticut
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District of Columbia
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Georgia
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Illinois
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Indiana
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Missouri
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North Carolina
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Utah
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Vermont
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West Virginia
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Wisconsin
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Innsbruck
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Linz
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Brugge
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Genk
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Rennes Cedex 9
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Toulouse Cedex 9
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Heidelberg
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Homburg/Saar
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Jena
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Ulm
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Bologna
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Mantova
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Verona
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Aomori Prefecture
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Russian Federation
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Riyadh
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Bratislava 37
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Burgos
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El Palmar
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Hsinchu
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Taipei
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Glasgow
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Liverpool
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London
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United Kingdom
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Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Medtronic Cardiac Rhythm and Heart Failure
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Bruce Wilkoff, MD
Address 0 0
The Cleveland Clinic
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02205359