Mid-Q Response Study

  • STATUS
    Recruiting
  • End date
    Jan 23, 2024
  • participants needed
    232
  • sponsor
    Medtronic Bakken Research Center
Updated on 23 May 2021
medical therapy
ejection fraction
beta blockers
left bundle branch block
beta-adrenergic blocking agents
angiotensin ii receptor antagonists

Summary

The Mid-Q Response study is a prospective, multi-center, randomized controlled, interventional, single-blinded, post-market study.

The purpose of the Mid-Q Response study is to test the hypothesis that the AdaptivCRT (aCRT) algorithm is superior to standard CRT therapy regarding patient outcomes in CRT indicated patients with moderate QRS duration, preserved atrioventricular (AV) conduction and left bundle branch block (LBBB).

The study will be executed at approximately 60 centers in Asia. The subjects will be randomly assigned in a 1:1 ratio to the aCRT ON (Adaptive Bi-V and LV) group or the aCRT OFF (Nonadaptive CRT) group.

The primary objective is to test the hypothesis that aCRT ON increases the proportion of patients that improve on the Clinical Composite Score (CCS) compared to aCRT OFF at 6 months of follow-up.

Details
Condition Right bundle branch block, Heart failure, Heart disease, Heart Failure NYHA Class III, Heart Failure NYHA Class II, Heart Failure NYHA Class IV, Heart Failure With Reduced Ejection Fraction, Congestive Heart Failure, Cardiac Disease, left bundle branch block, lbbb, cardiac failure, congestive heart disease
Treatment aCRT ON, aCRT OFF
Clinical Study IdentifierNCT04180696
SponsorMedtronic Bakken Research Center
Last Modified on23 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject is willing to sign and date the study Informed Consent Form (ICF)
Subject is indicated for a CRT device according to local guidelines
Subject has sinus rhythm at time of enrollment
Subject has a moderately wide intrinsic QRS duration 120 ms and <150 ms
Subject has Left Bundle Branch Block (LBBB) as documented on an ECG (preferably within 30 days prior to enrollment but up to 50 days is accepted) with Qs or rS in leads V1 and V2, and Mid-QRS notching or slurring in 2 of leads V1, V2, V5, V6, I, and aVL
Subject has intrinsic, normal AV conduction as documented on an ECG by a PR interval 200 ms (preferably within 30 days prior to enrollment but up to 50 days is accepted)
Subject has left ventricular ejection fraction 35% (documented within 180 days prior to enrollment)
Subject has 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 MRA

Exclusion Criteria

Subject is less than 18 years of age (or has not reached minimum age per local law if that is higher)
Subject is not expected to remain available for at least 1 year of follow-up visits
Subjects 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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