AdaptResponse Clinical Trial

• ClinicalTrials.gov Identifier: NCT02205359
• Recruitment Status: Completed
• First Posted: July 31, 2014
• Last Update Posted: January 27, 2023
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Information provided by (Responsible Party): Medtronic Cardiac Rhythm and Heart Failure

Tracking Information

• First Submitted Date: July 18, 2014
• First Posted Date: July 31, 2014
• Last Update Posted Date: January 27, 2023
• Study Start Date: July 2014
• Actual Primary Completion Date: November 2, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 29, 2014)

Combined endpoint of all-cause mortality and intervention for heart failure decompensation [ Time Frame: 2 years post randomization ]

Intervention for heart failure decompensation is defined as an event requiring invasive intervention or inpatient hospitalization.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 29, 2014)

• All-cause mortality [ Time Frame: 2 years post randomization ]
• Percent of patients with interventions for heart failure decompensation [ Time Frame: 2 years post randomization ]
  Intervention for heart failure decompensation is defined as an event requiring invasive intervention or inpatient hospitalization.
• Clinical Composite Score [ Time Frame: 6 months post randomization ]
  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.
• Atrial fibrillation [ Time Frame: 2 years post randomization ]
  Incidence of atrial fibrillation lasting >6 hours in one day
• Change in Quality of Life measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: Baseline to 2 years post randomization ]
  The overall summary score of the Kansas City Cardiomyopathy Questionnaire will be analyzed.
• Change in Quality of Life measured by the EQ-5D [ Time Frame: Baseline to 2 years post randomization ]
  The EQ-5D index score will be analyzed.
• All-cause re-admissions within 30-days after a heart failure admission [ Time Frame: 2 years post randomization ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: AdaptResponse Clinical Trial
• Official Title: AdaptResponse Clinical Trial
• 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Heart Failure With Left Bundle Branch Block

Intervention

• Device: aCRT ON
  CRT device with AdaptivCRT enabled
• Device: aCRT OFF
  CRT device with AdaptivCRT disabled

Study Arms

• 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
  Intervention: Device: aCRT ON
• Active Comparator: aCRT OFF
  Standard CRT
  Intervention: Device: aCRT OFF

Publications *

• Wilkoff BL, Birnie D, Gold MR, Hersi AS, Jacobs S, Gerritse B, Kusano K, Leclercq C, Mullens W, Filippatos G. Differences in clinical characteristics and reported quality of life of men and women undergoing cardiac resynchronization therapy. ESC Heart Fail. 2020 Oct;7(5):2972-2982. doi: 10.1002/ehf2.12914. Epub 2020 Aug 13.
• Filippatos G, Birnie D, Gold MR, Gerritse B, Hersi A, Jacobs S, Kusano K, Leclercq C, Mullens W, Wilkoff BL; AdaptResponse Investigators. Rationale and design of the AdaptResponse trial: a prospective randomized study of cardiac resynchronization therapy with preferential adaptive left ventricular-only pacing. Eur J Heart Fail. 2017 Jul;19(7):950-957. doi: 10.1002/ejhf.895.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 26, 2023): 3797
• Original Estimated Enrollment (submitted: July 29, 2014): 3000
• Actual Study Completion Date: November 2, 2022
• Actual Primary Completion Date: November 2, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Hungary, India, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Norway, Poland, Portugal, Puerto Rico, Russian Federation, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States

Administrative Information

• NCT Number: NCT02205359
• Other Study ID Numbers: AdaptResponse
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
• Original Responsible Party: Same as current
• Current Study Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Bruce Wilkoff, MD; The Cleveland Clinic

• PRS Account: Medtronic Cardiac Rhythm and Heart Failure
• Verification Date: January 2023