Mid-Q Response Study

NCT04180696 | Completed Results

• 1 other identifier: MDT18037
• Study Type: interventional
• Target: 177
• Locations: 10 countries
• Sites: 61

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

Outcome Measures

Primary Outcomes (1)

• Clinical Composite Score

  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.

  6 months post-randomization

Secondary Outcomes (4)

• Change in New York Heart Association (NYHA) Class

  Baseline to 6 and 12 months post-randomization

• Occurrence of Hospitalizations for Worsening Heart Failure

  12 months post-randomization

• All-cause Mortality

  12 months post-randomization

• Cardiovascular-related Mortality

  12 months post-randomization

Study Arms (2)

AdaptivCRT ON (aCRT ON, treatment group)

EXPERIMENTAL

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.

Device: aCRT ON

AdaptivCRT OFF (aCRT OFF, control group)

ACTIVE COMPARATOR

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.

Device: aCRT OFF

Interventions

aCRT ON DEVICE

CRT device with AdaptivCRT enabled

AdaptivCRT ON (aCRT ON, treatment group)

aCRT OFF DEVICE

CRT device with AdaptivCRT disabled

AdaptivCRT OFF (aCRT OFF, control group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead
• Medtronic: collaborator
• Medtronic Japan Co., Ltd.: collaborator

Study Sites (61)

Gleneagles Jerudong Park Medical Centre

Bandar Seri Begawan, Brunei

Location

Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location

Grantham Hospital

Hong Kong, Hong Kong

Location

Queen Elizabeth Hospital

Hong Kong, Hong Kong

Location

Tuen Mun Hospital

Hong Kong, Hong Kong

Location

National Cardiovascular Center Harapan Kita

Jakarta, 11420, Indonesia

Location

University of Fukui Hospital

Fukui, Japan

Location

Kokura Memorial Hospital

Fukuoka, Japan

Location

Hirosaki University Hospital

Hirosaki, Japan

Location

Hiroshima Prefectural Hospital

Hiroshima, Japan

Location

The Hospital of Hyogo College of Medicine

Hyōgo, Japan

Location

University of Tsukuba Hospital

Ibaraki, Japan

Location

Tokai University Hospital

Isehara, Japan

Location

Kitasato University Hospital

Kanagawa, Japan

Location

St. Marianna University School of Medicine Hospital

Kawasaki, Japan

Location

Saiseikai Kumamoto Hospital

Kumamoto, Japan

Location

Kurashiki Central Hospital

Kurashiki, Japan

Location

Tohoku University Hospital

Miyagi, Japan

Location

Miyazaki Medical Association Hospital

Miyazaki, Japan

Location

University of Miyazaki Hospital

Miyazaki, Japan

Location

Iwate Medical University Hospital

Morioka, Japan

Location

Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital

Nagoya, Japan

Location

Nagoya University Hospital

Nagoya, Japan

Location

Okayama University Hospital

Okayama, Japan

Location

The Sakakibara Heart Institute of Okayama

Okayama, Japan

Location

National Cerebral and Cardiovascular Center

Osaka, Japan

Location

Sakurabashi Watanabe Hospital

Osaka, Japan

Location

Japanese Red Cross Saitama Hospital

Saitama, Japan

Location

Saitama Medical Center Jichi Medical University

Saitama, Japan

Location

Saitama Medical University International Medical Center

Saitama, Japan

Location

Shizuoka General Hospital

Shizuoka, Japan

Location

Juntendo University Hospital

Tokyo, Japan

Location

Kyorin University Hospital

Tokyo, Japan

Location

Fujita Health University Hospital

Toyoake, Japan

Location

Yamagata Prefectural Central Hospital

Yamagata, Japan

Location

Saiseikai Yokohama tobu Hospital

Yokohama, Japan

Location

St. Marianna University Yokohama City Seibu Hospital

Yokohama, Japan

Location

Oita University Hospital

Yufu, Japan

Location

Hospital Sultanah Bahiyah

Alor Star, Malaysia

Location

Hospital Serdang

Kajang, Malaysia

Location

Sarawak Heart Center

Kota, Malaysia

Location

Institut Jantung Negara - National Heart Institute

Kuala Lumpur, Malaysia

Location

Sarawak Heart Centre

Kuching, Malaysia

Location

Makati Medical Center

Makati, Philippines

Location

Changi General Hospital

Singapore, Singapore

Location

National University Hospital

Singapore, Singapore

Location

Tan Tock Seng Hospital

Singapore, Singapore

Location

Sejong General Hospital

Bucheon-si, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Kyung Hee University Medical Center

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Bundang Hospital

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

National Taiwan University Hospital Hsin Chu Branch

Hsinchu, Taiwan

Location

Kaohsing Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

Chang Gung Memorial Hospital Linkou

Taoyuan, 333, Taiwan

Location

MeSH Terms

Conditions

Heart Failure; Bundle-Branch Block

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Heart Block; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Lidwien Vainer
• Organization: Medtronic, Bakken Research Center B.V.

lidwien.vainer@medtronic.com

+31610419653

Study Officials

• Kazutaka Aonuma, MD

  University of Tsukuba Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Eligible subjects will be randomized after baseline assessment and implant of a CRT system containing the aCRT algorithm. Randomization will be done in a 1:1 ratio to either treatment (aCRT ON, Adaptive Bi-V and LV) or control (aCRT OFF, Nonadaptive CRT) groups. All subjects, independent of randomization assignment, will have a CRT system.

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 27, 2019
• Study Start: January 23, 2020
• Primary Completion: March 28, 2024
• Study Completion: March 28, 2024
• Last Updated: July 9, 2025
• Results First Posted: May 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (3); JP (32); MY (5); ID (1); HK (3); TW (5); PH (1); BR (1); KR (9); CN (1)