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Mid-Q Response Study | Clinical Trials | Clareo Health

COMPLETEDNA

Mid-Q Response Study

NCT04180696•Medtronic Cardiac Rhythm and Heart Failure

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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).

Locations (61)

Gleneagles Jerudong Park Medical Centre

Bandar Seri Begawan, Brunei

Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, China

Grantham Hospital

Hong Kong, Hong Kong

Queen Elizabeth Hospital

Hong Kong, Hong Kong

Tuen Mun Hospital

Hong Kong, Hong Kong

National Cardiovascular Center Harapan Kita

Jakarta, Indonesia

University of Fukui Hospital

Fukui, Japan

Kokura Memorial Hospital

Fukuoka, Japan

Hirosaki University Hospital

Hirosaki, Japan

Hiroshima Prefectural Hospital

Hiroshima, Japan

Key Dates

Start Date

January 23, 2020

Primary Completion Date

March 28, 2024

Completion Date

March 28, 2024

Last Updated

July 9, 2025

Enrollment

177

ACTUAL participants

Conditions

Heart FailureLeft Bundle-Branch BlockHeart Failure With Reduced Ejection Fraction (HFrEF)Heart Failure NYHA Class IIHeart Failure NYHA Class IIIHeart Failure NYHA Class IV

Interventions

aCRT ON

DEVICE

aCRT OFF

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Mid-Q Response Study

Inclusion Criteria

Exclusion Criteria

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