Mid-Q Response Study

  • End date
    Jun 26, 2024
  • participants needed
  • sponsor
    Medtronic Bakken Research Center
Updated on 26 July 2022
medical therapy
ejection fraction
beta blockers
left bundle branch block
beta-adrenergic blocking agents
angiotensin ii receptor antagonists


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.

Condition Heart Failure, Left Bundle-Branch Block, Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure NYHA Class IV
Treatment aCRT ON, aCRT OFF
Clinical Study IdentifierNCT04180696
SponsorMedtronic Bakken Research Center
Last Modified on26 July 2022


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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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