Heart Failure Clinical Trial
Official title:
Mid-Q Response Study
Verified date | April 2024 |
Source | Medtronic Bakken Research Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Medtronic Bakken Research Center | Medtronic, Medtronic Japan Co., Ltd. |
Brunei Darussalam, China, Hong Kong, Indonesia, Japan, Korea, Republic of, Malaysia, Philippines, Singapore, Taiwan,
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 |
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