Mid-Q Response Study
- Conditions
- Heart Failure NYHA Class IIIHeart FailureLeft Bundle-Branch BlockHeart Failure NYHA Class IIHeart Failure With Reduced Ejection Fraction (HFrEF)Heart Failure NYHA Class IV
- Interventions
- Device: aCRT ONDevice: aCRT OFF
- Registration Number
- NCT04180696
- Lead Sponsor
- Medtronic Bakken Research Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 177
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AdaptivCRT ON (aCRT ON, treatment group) aCRT ON 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. AdaptivCRT OFF (aCRT OFF, control group) aCRT OFF 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.
- 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 Occurrence of hospitalizations for worsening heart failure 12 months post-randomization Defined as an event requiring inpatient hospitalization or invasive intervention
All-cause and cardiovascular related mortality 12 months post-randomization
Trial Locations
- Locations (61)
Kyung Hee University Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seoul, Korea, Republic of
Sejong General Hospital
🇰🇷Bucheon, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Kitasato University Hospital
🇯🇵Kanagawa, Japan
Saiseikai Kumamoto Hospital
🇯🇵Kumamoto, Japan
Grantham Hospital
🇭🇰Hong Kong, Hong Kong
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
National Cardiovascular Center Harapan Kita
🇮🇩Jakarta, Indonesia
National Taiwan University Hospital Hsin Chu Branch
🇨🇳Hsinchu, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung City, Taiwan
Tan Tock Seng Hospital
🇸🇬Singapore, Singapore
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
Chang Gung Memorial Hospital Linkou
🇨🇳Taoyuan City, Taiwan
Gleneagles Jerudong Park Medical Centre
🇧🇳Bandar Seri Begawan, Brunei Darussalam
University of Fukui Hospital
🇯🇵Fukui, Japan
Hirosaki University Hospital
🇯🇵Hirosaki, Japan
Hiroshima Prefectural Hospital
🇯🇵Hiroshima, Japan
University of Miyazaki Hospital
🇯🇵Miyazaki, Japan
Nagoya University Hospital
🇯🇵Nagoya, Japan
National Cerebral and Cardiovascular Center
🇯🇵Osaka, Japan
Saiseikai Yokohama tobu Hospital
🇯🇵Yokohama, Japan
Yamagata Prefectural Central Hospital
🇯🇵Yamagata, Japan
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Oita University Hospital
🇯🇵Yufu, Japan
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Hospital Sultanah Bahiyah
🇲🇾Alor Setar, Malaysia
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Sarawak Heart Centre
🇲🇾Kuching, Malaysia
Hospital Serdang
🇲🇾Kajang, Malaysia
Institut Jantung Negara - National Heart Institute
🇲🇾Kuala Lumpur, Malaysia
Changi General Hospital
🇸🇬Singapore, Singapore
Kaohsing Chang Gung Memorial Hospital
🇨🇳Kaohsiung City, Taiwan
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, China
Iwate Medical University Hospital
🇯🇵Morioka, Japan
Okayama University Hospital
🇯🇵Okayama, Japan
The Sakakibara Heart Institute of Okayama
🇯🇵Okayama, Japan
St. Marianna University Yokohama City Seibu Hospital
🇯🇵Yokohama, Japan
National University Hospital
🇸🇬Singapore, Singapore
Miyazaki Medical Association Hospital
🇯🇵Miyazaki, Japan
The Hospital of Hyogo College of Medicine
🇯🇵Hyōgo, Japan
Tokai University Hospital
🇯🇵Isehara, Japan
St. Marianna University School of Medicine Hospital
🇯🇵Kawasaki, Japan
Tohoku University Hospital
🇯🇵Miyagi, Japan
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
🇯🇵Nagoya, Japan
Sakurabashi Watanabe Hospital
🇯🇵Osaka, Japan
Saitama Medical Center Jichi Medical University
🇯🇵Saitama, Japan
Kyorin University Hospital
🇯🇵Tokyo, Japan
Saitama Medical University International Medical Center
🇯🇵Saitama, Japan
Kokura Memorial Hospital
🇯🇵Fukuoka, Japan
University of Tsukuba Hospital
🇯🇵Ibaraki, Japan
Japanese Red Cross Saitama Hospital
🇯🇵Saitama, Japan
Shizuoka General Hospital
🇯🇵Shizuoka, Japan
Juntendo University Hospital
🇯🇵Tokyo, Japan
Fujita Health University Hospital
🇯🇵Toyoake, Japan
Sarawak Heart Center
🇲🇾Kota, Malaysia
Kurashiki Central Hospital
🇯🇵Kurashiki, Japan
Makati Medical Center
🇵🇭Makati, Philippines
Tuen Mun Hospital
🇭🇰Hong Kong, Hong Kong
Queen Elizabeth Hospital
🇭🇰Hong Kong, Hong Kong