Mid-Q Response Study

Heart Failure Clinical Trial

Official title:

Mid-Q Response Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04180696
• Other study ID #: MDT18037
• Status: Completed
• Phase: N/A
• Start date: January 23, 2020
• Est. completion date: March 28, 2024

Study information

• Verified date: April 2024
• Source: Medtronic Bakken Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: March 28, 2024
• Est. primary completion date: March 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• aCRT ON
CRT device with AdaptivCRT enabled
• aCRT OFF
CRT device with AdaptivCRT disabled

Locations

Country	Name	City	State
Brunei Darussalam	Gleneagles Jerudong Park Medical Centre	Bandar Seri Begawan
China	Ruijin Hospital Shanghai Jiao Tong University School of Medicine	Shanghai
Hong Kong	Grantham Hospital	Hong Kong
Hong Kong	Queen Elizabeth Hospital	Hong Kong
Hong Kong	Tuen Mun Hospital	Hong Kong
Indonesia	National Cardiovascular Center Harapan Kita	Jakarta
Japan	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	Hyogo
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
Korea, Republic of	Sejong General Hospital	Bucheon
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Kyung Hee University Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Bundang Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Malaysia	Hospital Sultanah Bahiyah	Alor Setar
Malaysia	Hospital Serdang	Kajang
Malaysia	Sarawak Heart Center	Kota
Malaysia	Institut Jantung Negara - National Heart Institute	Kuala Lumpur
Malaysia	Sarawak Heart Centre	Kuching
Philippines	Makati Medical Center	Makati
Singapore	Changi General Hospital	Singapore
Singapore	National University Hospital	Singapore
Singapore	Tan Tock Seng Hospital	Singapore
Taiwan	National Taiwan University Hospital Hsin Chu Branch	Hsinchu
Taiwan	Kaohsing Chang Gung Memorial Hospital	Kaohsiung City
Taiwan	Taichung Veterans General Hospital	Taichung City
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Chang Gung Memorial Hospital Linkou	Taoyuan City

Sponsors (3)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center	Medtronic, Medtronic Japan Co., Ltd.

Countries where clinical trial is conducted

Brunei Darussalam,  China,  Hong Kong,  Indonesia,  Japan,  Korea, Republic of,  Malaysia,  Philippines,  Singapore,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in quality of life	QoL will be measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ); the overall summary score of the KCCQ will be analyzed.; The responses are categorized under 3 subscales (symptom burden, physical limitation and quality of life) with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The total KCCQ score represents the mean of the three subscale scores.	Baseline to 6 and 12 months post-randomization
Other	Combined effects of height, QRS durations, and aCRT on clinical outcomes measured by the Clinical Composite Score	The combined effects of height, QRS duration and aCRT on the Clinical Composite Score will be assessed from the coefficients of a multivariable logistic regression model.	12 months post-randomization
Other	Incidence of atrial fibrillation		12 months post-randomization
Other	Occurrence of cardiovascular adverse events		12 months post-randomization
Other	Degree of reverse cardiac remodeling		12 months post-randomization
Primary	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	Change in New York Heart Association (NYHA) Class		Baseline to 6 and 12 months post-randomization
Secondary	Occurrence of hospitalizations for worsening heart failure	Defined as an event requiring inpatient hospitalization or invasive intervention	12 months post-randomization
Secondary	All-cause and cardiovascular related mortality		12 months post-randomization