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AdaptResponse Clinical Trial

This study is currently recruiting participants.
Verified February 2017 by Medtronic Cardiac Rhythm and Heart Failure
Sponsor:
ClinicalTrials.gov Identifier:
NCT02205359
First Posted: July 31, 2014
Last Update Posted: February 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure
  Purpose
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).

Condition Intervention
Heart Failure With Left Bundle Branch Block Device: aCRT ON Device: aCRT OFF

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: AdaptResponse Clinical Trial

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm and Heart Failure:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 3000
Study Start Date: July 2014
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Device: aCRT ON
CRT device with AdaptivCRT enabled
Active Comparator: aCRT OFF
Standard CRT
Device: aCRT OFF
CRT device with AdaptivCRT disabled

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02205359


Contacts
Contact: AdaptResponse Trial Leader medtronicCRMtrials@medtronic.com

  Show 204 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
Study Chair: Bruce Wilkoff, MD The Cleveland Clinic
Study Director: David Steinhaus, MD Medtronic Cardiac Rhythm and Heart Failure
  More Information

Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT02205359     History of Changes
Other Study ID Numbers: AdaptResponse
First Submitted: July 18, 2014
First Posted: July 31, 2014
Last Update Posted: February 28, 2017
Last Verified: February 2017

Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
AdaptivCRT
aCRT

Additional relevant MeSH terms:
Heart Failure
Bundle-Branch Block
Heart Diseases
Cardiovascular Diseases
Heart Block
Arrhythmias, Cardiac
Pathologic Processes