Mid-Q Response Study

Not Applicable

Completed

Conditions: Heart Failure NYHA Class III
Heart Failure
Left Bundle-Branch Block
Heart Failure NYHA Class II
Heart Failure With Reduced Ejection Fraction (HFrEF)
Heart Failure NYHA Class IV

Brief 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.

Recruitment & Eligibility

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.

Primary Outcome Measures

Name	Time	Method
Clinical Composite Score	6 months post-randomization	The Clinical Composite Score (CCS) classifies patients according their clinical status at 6 months post-randomization into categories Improved, Unchanged, and Worsened. A patient is classified Worsened in case of death, hospitalization for worsening heart failure, worsened New York Heart Association (NYHA) class (using last observation carried forward), or worsened status on the Global Assessment Score. Also, patients that exit the study or cross over because of worsening heart failure are classified Worsened. A patient is classified Improved when not Worsened and there is an improvement in NYHA class or Global Assessment Score. Patients that are not Worsened or Improved are Unchanged including all patients that miss NYHA class and Global Assessment Score data and are not classified Worsened because of death, HF hospitalization, exit or crossover.

Secondary Outcome Measures

Name	Time	Method
Change in New York Heart Association (NYHA) Class	Baseline to 6 and 12 months post-randomization	NYHA class is an ordinal variable with higher classes indicating a worse degree of heart failure: Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
Occurrence of Hospitalizations for Worsening Heart Failure	12 months post-randomization	Defined as an event requiring inpatient hospitalization or invasive intervention
All-cause Mortality	12 months post-randomization	All-cause mortality in the aCRT ON group vs the aCRT OFF group
Cardiovascular-related Mortality	12 months post-randomization	Defined as all cardiac deaths as well as any cardiovascular deaths that are not directly a result of mechanical or electrical heart dysfunction.

Locations (61): Gleneagles Jerudong Park Medical Centre
🇧🇳
Bandar Seri Begawan, Brunei Darussalam
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
Scroll for more (51 remaining)
Gleneagles Jerudong Park Medical Centre
🇧🇳Bandar Seri Begawan, Brunei Darussalam