AdaptResponse Clinical Trial

Completed · Not applicable

Conditions studied: Heart Failure With Left Bundle Branch Block

In brief

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).

Key facts

Study ID

NCT02205359

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

3797

Starts

2014-08-01

Expected to finish

2022-11-02

Last updated by the study team

2023-11-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Phoenix Cardiovascular Research Group, LLC — Phoenix, Arizona, United States
• Saint Vincent Heart Clinic Arkansas — Little Rock, Arkansas, United States
• Scripps Green Hospital Scripps Clinic Torrey Pines — La Jolla, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Coggins & Levy Medical Associates — San Jose, California, United States
• Stanford Hospital & Clinics — Stanford, California, United States
• Saint Joseph's Medical Center — Stockton, California, United States
• Penrose Hospital — Colorado Springs, Colorado, United States
• Medical Center of the Rockies — Loveland, Colorado, United States
• Bridgeport Hospital — Bridgeport, Connecticut, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Heart & Vascular Institute of Florida — Clearwater, Florida, United States
• Florida Heart Rhythm Specialists PLLC — Fort Lauderdale, Florida, United States
• The Cardiac & Vascular Institute — Gainesville, Florida, United States
• First Coast Cardiovascular Institute PA — Jacksonville, Florida, United States
• Cardiovascular Research Center of South Florida — Miami, Florida, United States
• AdventHealth Cardiovascular Research Institute — Orlando, Florida, United States
• Cardiology Institute of Northwest Florida — Panama City, Florida, United States
• University of South Florida Health (USF) — Tampa, Florida, United States
• Emory University Hospital Midtown — Atlanta, Georgia, United States
• Piedmont Heart Institute — Atlanta, Georgia, United States
• Northwerstern University — Chicago, Illinois, United States
• Prairie Education and Research Cooperative — Springfield, Illinois, United States
• Saint Francis Medical Group Indiana Heart Physician — Indianapolis, Indiana, United States
• CardioVascular Associates of Mesa — Mesa, Arizona, United States

Full record on ClinicalTrials.gov

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