Mid-Q Response Study

NCT ID: NCT04180696

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 177 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-23
• Study Completion Date: 2024-03-28

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

AdaptivCRT ON (aCRT ON, treatment group)

AdaptivCRT programmed to "Adaptive Bi-V and LV The aCRT algorithm has been developed to provide RV-synchronized LV pacing when intrinsic AV conduction is normal or BiV pacing otherwise.

Group Type: EXPERIMENTAL

aCRT ON

Intervention Type: DEVICE

CRT device with AdaptivCRT enabled

AdaptivCRT OFF (aCRT OFF, control group)

AdaptivCRT programmed to "Nonadaptive CRT" (standard CRT). Control group subjects will be optimized per physician's discretion. The method of AV and VV optimization in the control group will be collected.

Group Type: ACTIVE_COMPARATOR

aCRT OFF

Intervention Type: DEVICE

CRT device with AdaptivCRT disabled

Interventions

aCRT ON

CRT device with AdaptivCRT enabled

Intervention Type: DEVICE

aCRT OFF

CRT device with AdaptivCRT disabled

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Medtronic Japan Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kazutaka Aonuma, MD

Role: STUDY_CHAIR

University of Tsukuba Hospital

Locations

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

The Hospital of Hyogo College of Medicine

Hyōgo, , Japan

University of Tsukuba Hospital

Ibaraki, , Japan

Tokai University Hospital

Isehara, , Japan

Kitasato University Hospital

Kanagawa, , Japan

St. Marianna University School of Medicine Hospital

Kawasaki, , Japan

Saiseikai Kumamoto Hospital

Kumamoto, , Japan

Kurashiki Central Hospital

Kurashiki, , Japan

Tohoku University Hospital

Miyagi, , Japan

Miyazaki Medical Association Hospital

Miyazaki, , Japan

University of Miyazaki Hospital

Miyazaki, , Japan

Iwate Medical University Hospital

Morioka, , Japan

Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital

Nagoya, , Japan

Nagoya University Hospital

Nagoya, , Japan

Okayama University Hospital

Okayama, , Japan

The Sakakibara Heart Institute of Okayama

Okayama, , Japan

National Cerebral and Cardiovascular Center

Osaka, , Japan

Sakurabashi Watanabe Hospital

Osaka, , Japan

Japanese Red Cross Saitama Hospital

Saitama, , Japan

Saitama Medical Center Jichi Medical University

Saitama, , Japan

Saitama Medical University International Medical Center

Saitama, , Japan

Shizuoka General Hospital

Shizuoka, , Japan

Juntendo University Hospital

Tokyo, , Japan

Kyorin University Hospital

Tokyo, , Japan

Fujita Health University Hospital

Toyoake, , Japan

Yamagata Prefectural Central Hospital

Yamagata, , Japan

Saiseikai Yokohama tobu Hospital

Yokohama, , Japan

St. Marianna University Yokohama City Seibu Hospital

Yokohama, , Japan

Oita University Hospital

Yufu, , Japan

Hospital Sultanah Bahiyah

Alor Star, , Malaysia

Hospital Serdang

Kajang, , Malaysia

Sarawak Heart Center

Kota, , Malaysia

Institut Jantung Negara - National Heart Institute

Kuala Lumpur, , Malaysia

Sarawak Heart Centre

Kuching, , Malaysia

Makati Medical Center

Makati, , Philippines

Changi General Hospital

Singapore, , Singapore

National University Hospital

Singapore, , Singapore

Tan Tock Seng Hospital

Singapore, , Singapore

Sejong General Hospital

Bucheon-si, , South Korea

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Asan Medical Center

Seoul, , South Korea

Korea University Anam Hospital

Seoul, , South Korea

Kyung Hee University Medical Center

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Seoul National University Bundang Hospital

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Severance Hospital

Seoul, , South Korea

National Taiwan University Hospital Hsin Chu Branch

Hsinchu, , Taiwan

Kaohsing Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Taichung Veterans General Hospital

Taichung, , Taiwan

National Cheng Kung University Hospital

Tainan City, , Taiwan

Chang Gung Memorial Hospital Linkou

Taoyuan, , Taiwan

Countries

Brunei; China; Hong Kong; Indonesia; Japan; Malaysia; Philippines; Singapore; South Korea; Taiwan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

MDT18037

Identifier Type: -

Identifier Source: org_study_id