Clinical trial NCT04180696: Mid-Q Response Study
Official title: Mid-Q Response Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
name: Medtronic Japan Co., Ltd.
First posted: 2019-11-27
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


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).
* Subject meets any exclusion criteria required by local law.

Primary outcomes:
measure: Clinical Composite Score
timeFrame: 6 months post-randomization
Secondary outcomes:
measure: Change in New York Heart Association (NYHA) Class
timeFrame: Baseline to 6 and 12 months post-randomization
measure: Occurrence of Hospitalizations for Worsening Heart Failure
timeFrame: 12 months post-randomization
measure: All-cause Mortality
timeFrame: 12 months post-randomization
measure: Cardiovascular-related Mortality
timeFrame: 12 months post-randomization
Other outcomes:
Locations:
city: Bandar Seri Begawan
country: Brunei Darussalam
facility: Gleneagles Jerudong Park Medical Centre
city: Shanghai
country: China
facility: Ruijin Hospital Shanghai Jiao Tong University School of Medicine
city: Hong Kong
country: Hong Kong
facility: Grantham Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Elizabeth Hospital
city: Hong Kong
country: Hong Kong
facility: Tuen Mun Hospital
city: Jakarta
country: Indonesia
facility: National Cardiovascular Center Harapan Kita
city: Fukui
country: Japan
facility: University of Fukui Hospital
city: Fukuoka
country: Japan
facility: Kokura Memorial Hospital
city: Hirosaki
country: Japan
facility: Hirosaki University Hospital
city: Hiroshima
country: Japan
facility: Hiroshima Prefectural Hospital
city: Hyōgo
country: Japan
facility: The Hospital of Hyogo College of Medicine
city: Ibaraki
country: Japan
facility: University of Tsukuba Hospital
city: Isehara
country: Japan
facility: Tokai University Hospital
city: Kanagawa
country: Japan
facility: Kitasato University Hospital
city: Kawasaki
country: Japan
facility: St. Marianna University School of Medicine Hospital
city: Kumamoto
country: Japan
facility: Saiseikai Kumamoto Hospital
city: Kurashiki
country: Japan
facility: Kurashiki Central Hospital
city: Miyagi
country: Japan
facility: Tohoku University Hospital
city: Miyazaki
country: Japan
facility: Miyazaki Medical Association Hospital
city: Miyazaki
country: Japan
facility: University of Miyazaki Hospital
city: Morioka
country: Japan
facility: Iwate Medical University Hospital
city: Nagoya
country: Japan
facility: Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
city: Nagoya
country: Japan
facility: Nagoya University Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Okayama
country: Japan
facility: The Sakakibara Heart Institute of Okayama
city: Osaka
country: Japan
facility: National Cerebral and Cardiovascular Center
city: Osaka
country: Japan
facility: Sakurabashi Watanabe Hospital
city: Saitama
country: Japan
facility: Japanese Red Cross Saitama Hospital
city: Saitama
country: Japan
facility: Saitama Medical Center Jichi Medical University
city: Saitama
country: Japan
facility: Saitama Medical University International Medical Center
city: Shizuoka
country: Japan
facility: Shizuoka General Hospital
city: Tokyo
country: Japan
facility: Juntendo University Hospital
city: Tokyo
country: Japan
facility: Kyorin University Hospital
city: Toyoake
country: Japan
facility: Fujita Health University Hospital
city: Yamagata
country: Japan
facility: Yamagata Prefectural Central Hospital
city: Yokohama
country: Japan
facility: Saiseikai Yokohama tobu Hospital
city: Yokohama
country: Japan
facility: St. Marianna University Yokohama City Seibu Hospital
city: Yufu
country: Japan
facility: Oita University Hospital
city: Bucheon
country: Korea, Republic of
facility: Sejong General Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Alor Setar
country: Malaysia
facility: Hospital Sultanah Bahiyah
city: Kajang
country: Malaysia
facility: Hospital Serdang
city: Kota
country: Malaysia
facility: Sarawak Heart Center
city: Kuala Lumpur
country: Malaysia
facility: Institut Jantung Negara - National Heart Institute
city: Kuching
country: Malaysia
facility: Sarawak Heart Centre
city: Makati
country: Philippines
facility: Makati Medical Center
city: Singapore
country: Singapore
facility: Changi General Hospital
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital Hsin Chu Branch
city: Kaohsiung City
country: Taiwan
facility: Kaohsing Chang Gung Memorial Hospital
city: Taichung City
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital Linkou
Study officials:
affiliation: University of Tsukuba Hospital
name: Kazutaka Aonuma, MD
role: STUDY_CHAIR
References: