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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02205359
Ethics application status
Date submitted
18/07/2014
Date registered
31/07/2014
Date last updated
9/06/2020

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

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 - Intervention for heart failure decompensation is defined as an event requiring invasive intervention or inpatient hospitalization.
Timepoint [1] 0 0
2 years post randomization
Secondary outcome [1] 0 0
All-cause mortality
Timepoint [1] 0 0
2 years post randomization
Secondary outcome [2] 0 0
Percent of patients with interventions for heart failure decompensation - Intervention for heart failure decompensation is defined as an event requiring invasive intervention or inpatient hospitalization.
Timepoint [2] 0 0
2 years post randomization
Secondary outcome [3] 0 0
Clinical Composite Score - The Clinical Composite Score classifies patients according their clinical status at 6 months post randomization into categories Improved, Unchanged, and Worsened. A patient is classified Worsened in case of death, hospitalization for worsening heart failure, worsened NYHA class (using last observation carried forward), or worsened status on the Global Assessment Score. Also patients that exit the study or cross over because of worsening heart failure are classified Worsened. A patient is classified Improved when not Worsened and there is an improvement in NYHA class or Global Assessment Score. Patients that are not Worsened or Improved are Unchanged.
Timepoint [3] 0 0
6 months post randomization
Secondary outcome [4] 0 0
Atrial fibrillation - Incidence of atrial fibrillation lasting >6 hours in one day
Timepoint [4] 0 0
2 years post randomization
Secondary outcome [5] 0 0
Change in Quality of Life measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) - The overall summary score of the Kansas City Cardiomyopathy Questionnaire will be analyzed.
Timepoint [5] 0 0
Baseline to 2 years post randomization
Secondary outcome [6] 0 0
Change in Quality of Life measured by the EQ-5D - The EQ-5D index score will be analyzed.
Timepoint [6] 0 0
Baseline to 2 years post randomization
Secondary outcome [7] 0 0
All-cause re-admissions within 30-days after a heart failure admission
Timepoint [7] 0 0
2 years post randomization

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
Gender
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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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Badajoz
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Burgos
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Granada
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Málaga
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Salamanca
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Santa Cruz de Tenerife
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Basel
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Hsinchu
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Taipei
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United Kingdom
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Glasgow
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Liverpool
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London

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
The purpose of this clinical study is to test the hypothesis that market released Cardiac
Resynchronization Therapy (CRT) devices which contain the AdaptivCRT® (aCRT) algorithm have a
superior outcome compared to standard CRT devices in CRT indicated patients with normal
atrio-ventricular (AV) conduction and left bundle branch block (LBBB).
Trial website
https://clinicaltrials.gov/show/NCT02205359
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

Summary results
Other publications