AdaptResponse Clinical Trial

Trial ID or NCT#

NCT02205359

Status

recruiting iconRECRUITING

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).

Official Title

AdaptResponse Clinical Trial

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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.
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Investigator(s)

Mohan Viswanathan
Mohan Viswanathan
Cardiac electrophysiologist
Clinical Professor, Medicine - Cardiovascular Medicine

Contact us to find out if this trial is right for you.

Contact

Linda Norton, RN, MSN
(650) 725-5597

View on ClinicalTrials.gov