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Mid-Q Response Study

Primary Purpose

Heart Failure, Left Bundle-Branch Block, Heart Failure With Reduced Ejection Fraction (HFrEF)

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
aCRT ON
aCRT OFF
Sponsored by
Medtronic Bakken Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Gleneagles Jerudong Park Medical Centre
  • Ruijin Hospital Shanghai Jiao Tong University School of Medicine
  • Grantham Hospital
  • Queen Elizabeth Hospital
  • Tuen Mun Hospital
  • National Cardiovascular Center Harapan Kita
  • University of Fukui Hospital
  • Kokura Memorial Hospital
  • Hirosaki University Hospital
  • Hiroshima Prefectural Hospital
  • The Hospital of Hyogo College of Medicine
  • University of Tsukuba Hospital
  • Tokai University Hospital
  • Kitasato University Hospital
  • St. Marianna University School of Medicine Hospital
  • Saiseikai Kumamoto Hospital
  • Kurashiki Central Hospital
  • Tohoku University Hospital
  • Miyazaki Medical Association Hospital
  • University of Miyazaki Hospital
  • Iwate Medical University Hospital
  • Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
  • Nagoya University Hospital
  • Okayama University Hospital
  • The Sakakibara Heart Institute of Okayama
  • National Cerebral and Cardiovascular Center
  • Sakurabashi Watanabe Hospital
  • Japanese Red Cross Saitama Hospital
  • Saitama Medical Center Jichi Medical University
  • Saitama Medical University International Medical Center
  • Shizuoka General Hospital
  • Juntendo University Hospital
  • Kyorin University Hospital
  • Fujita Health University Hospital
  • Yamagata Prefectural Central Hospital
  • Saiseikai Yokohama tobu Hospital
  • St. Marianna University Yokohama City Seibu Hospital
  • Oita University Hospital
  • Sejong General Hospital
  • Keimyung University Dongsan Medical Center
  • Asan Medical Center
  • Korea University Anam Hospital
  • Kyung Hee University Medical Center
  • Samsung Medical Center
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Severance Hospital
  • Sarawak Heart Center
  • Hospital Sultanah Bahiyah
  • Hospital Serdang
  • Institut Jantung Negara - National Heart Institute
  • Sarawak Heart Centre
  • Makati Medical Center
  • Changi General Hospital
  • National University Hospital
  • Tan Tock Seng Hospital
  • National Taiwan University Hospital Hsin Chu Branch
  • Kaohsing Chang Gung Memorial Hospital
  • Taichung Veterans General Hospital
  • National Cheng Kung University Hospital
  • Chang Gung Memorial Hospital Linkou

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AdaptivCRT ON (aCRT ON, treatment group)

AdaptivCRT OFF (aCRT OFF, control group)

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in New York Heart Association (NYHA) Class
Occurrence of hospitalizations for worsening heart failure
Defined as an event requiring inpatient hospitalization or invasive intervention
All-cause and cardiovascular related mortality

Full Information

First Posted
November 18, 2019
Last Updated
May 25, 2023
Sponsor
Medtronic Bakken Research Center
Collaborators
Medtronic, Medtronic Japan Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04180696
Brief Title
Mid-Q Response Study
Official Title
Mid-Q Response Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 23, 2020 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Bakken Research Center
Collaborators
Medtronic, Medtronic Japan Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Allocation
Randomized
Enrollment
232 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AdaptivCRT ON (aCRT ON, treatment group)
Arm Type
Experimental
Arm Description
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.
Arm Title
AdaptivCRT OFF (aCRT OFF, control group)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
aCRT ON
Intervention Description
CRT device with AdaptivCRT enabled
Intervention Type
Device
Intervention Name(s)
aCRT OFF
Intervention Description
CRT device with AdaptivCRT disabled
Primary Outcome Measure Information:
Title
Clinical Composite Score
Description
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
Time Frame
6 months post-randomization
Secondary Outcome Measure Information:
Title
Change in New York Heart Association (NYHA) Class
Time Frame
Baseline to 6 and 12 months post-randomization
Title
Occurrence of hospitalizations for worsening heart failure
Description
Defined as an event requiring inpatient hospitalization or invasive intervention
Time Frame
12 months post-randomization
Title
All-cause and cardiovascular related mortality
Time Frame
12 months post-randomization
Other Pre-specified Outcome Measures:
Title
Change in quality of life
Description
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.
Time Frame
Baseline to 6 and 12 months post-randomization
Title
Combined effects of height, QRS durations, and aCRT on clinical outcomes measured by the Clinical Composite Score
Description
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.
Time Frame
12 months post-randomization
Title
Incidence of atrial fibrillation
Time Frame
12 months post-randomization
Title
Occurrence of cardiovascular adverse events
Time Frame
12 months post-randomization
Title
Degree of reverse cardiac remodeling
Time Frame
12 months post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kazutaka Aonuma, MD
Organizational Affiliation
University of Tsukuba Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Gleneagles Jerudong Park Medical Centre
City
Bandar Seri Begawan
Country
Brunei Darussalam
Facility Name
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
City
Shanghai
Country
China
Facility Name
Grantham Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Queen Elizabeth Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Tuen Mun Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
National Cardiovascular Center Harapan Kita
City
Jakarta
ZIP/Postal Code
11420
Country
Indonesia
Facility Name
University of Fukui Hospital
City
Fukui
Country
Japan
Facility Name
Kokura Memorial Hospital
City
Fukuoka
Country
Japan
Facility Name
Hirosaki University Hospital
City
Hirosaki
Country
Japan
Facility Name
Hiroshima Prefectural Hospital
City
Hiroshima
Country
Japan
Facility Name
The Hospital of Hyogo College of Medicine
City
Hyōgo
Country
Japan
Facility Name
University of Tsukuba Hospital
City
Ibaraki
Country
Japan
Facility Name
Tokai University Hospital
City
Isehara
Country
Japan
Facility Name
Kitasato University Hospital
City
Kanagawa
Country
Japan
Facility Name
St. Marianna University School of Medicine Hospital
City
Kawasaki
Country
Japan
Facility Name
Saiseikai Kumamoto Hospital
City
Kumamoto
Country
Japan
Facility Name
Kurashiki Central Hospital
City
Kurashiki
Country
Japan
Facility Name
Tohoku University Hospital
City
Miyagi
Country
Japan
Facility Name
Miyazaki Medical Association Hospital
City
Miyazaki
Country
Japan
Facility Name
University of Miyazaki Hospital
City
Miyazaki
Country
Japan
Facility Name
Iwate Medical University Hospital
City
Morioka
Country
Japan
Facility Name
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
City
Nagoya
Country
Japan
Facility Name
Nagoya University Hospital
City
Nagoya
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama
Country
Japan
Facility Name
The Sakakibara Heart Institute of Okayama
City
Okayama
Country
Japan
Facility Name
National Cerebral and Cardiovascular Center
City
Osaka
Country
Japan
Facility Name
Sakurabashi Watanabe Hospital
City
Osaka
Country
Japan
Facility Name
Japanese Red Cross Saitama Hospital
City
Saitama
Country
Japan
Facility Name
Saitama Medical Center Jichi Medical University
City
Saitama
Country
Japan
Facility Name
Saitama Medical University International Medical Center
City
Saitama
Country
Japan
Facility Name
Shizuoka General Hospital
City
Shizuoka
Country
Japan
Facility Name
Juntendo University Hospital
City
Tokyo
Country
Japan
Facility Name
Kyorin University Hospital
City
Tokyo
Country
Japan
Facility Name
Fujita Health University Hospital
City
Toyoake
Country
Japan
Facility Name
Yamagata Prefectural Central Hospital
City
Yamagata
Country
Japan
Facility Name
Saiseikai Yokohama tobu Hospital
City
Yokohama
Country
Japan
Facility Name
St. Marianna University Yokohama City Seibu Hospital
City
Yokohama
Country
Japan
Facility Name
Oita University Hospital
City
Yufu
Country
Japan
Facility Name
Sejong General Hospital
City
Bucheon
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Kyung Hee University Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Sarawak Heart Center
City
Kota Samarahan
State/Province
Sarawak
Country
Malaysia
Facility Name
Hospital Sultanah Bahiyah
City
Alor Setar
Country
Malaysia
Facility Name
Hospital Serdang
City
Kajang
Country
Malaysia
Facility Name
Institut Jantung Negara - National Heart Institute
City
Kuala Lumpur
Country
Malaysia
Facility Name
Sarawak Heart Centre
City
Kuching
Country
Malaysia
Facility Name
Makati Medical Center
City
Makati
Country
Philippines
Facility Name
Changi General Hospital
City
Singapore
Country
Singapore
Facility Name
National University Hospital
City
Singapore
Country
Singapore
Facility Name
Tan Tock Seng Hospital
City
Singapore
Country
Singapore
Facility Name
National Taiwan University Hospital Hsin Chu Branch
City
Hsinchu
Country
Taiwan
Facility Name
Kaohsing Chang Gung Memorial Hospital
City
Kaohsiung City
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung City
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital Linkou
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

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Mid-Q Response Study

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