Heart FailureNCT04180696
Mid-Q Response Study
A study testing aCRT ON and aCRT OFF in people with Heart Failure and Left Bundle-Branch Block, run by Medtronic Cardiac Rhythm and Heart Failure at 61 sites in 10 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Left Bundle-Branch Block, Heart Failure With Reduced Ejection Fraction (HFrEF)
- What is being tested?
- aCRT ON and aCRT OFF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 61 sitesin 10 countries
- Study dates
- 23 Jan 2020to 28 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
61 sites in 10 countries.
61 sites in 10 countries
Japan32 sites
University of Fukui Hospital
Fukui
Kokura Memorial Hospital
Fukuoka
Hirosaki University Hospital
Hirosaki
Hiroshima Prefectural Hospital
Hiroshima
The Hospital of Hyogo College of Medicine
Hyōgo
University of Tsukuba Hospital
Ibaraki
Tokai University Hospital
Isehara
Kitasato University Hospital
Kanagawa
St. Marianna University School of Medicine Hospital
Kawasaki
Saiseikai Kumamoto Hospital
Kumamoto
Kurashiki Central Hospital
Kurashiki
Tohoku University Hospital
Miyagi
Miyazaki Medical Association Hospital
Miyazaki
University of Miyazaki Hospital
Miyazaki
Iwate Medical University Hospital
Morioka
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Nagoya
Nagoya University Hospital
Nagoya
Okayama University Hospital
Okayama
The Sakakibara Heart Institute of Okayama
Okayama
National Cerebral and Cardiovascular Center
Osaka
Sakurabashi Watanabe Hospital
Osaka
Japanese Red Cross Saitama Hospital
Saitama
Saitama Medical Center Jichi Medical University
Saitama
Saitama Medical University International Medical Center
Saitama
Shizuoka General Hospital
Shizuoka
Juntendo University Hospital
Tokyo
Kyorin University Hospital
Tokyo
Fujita Health University Hospital
Toyoake
Yamagata Prefectural Central Hospital
Yamagata
Saiseikai Yokohama tobu Hospital
Yokohama
St. Marianna University Yokohama City Seibu Hospital
Yokohama
Oita University Hospital
Yufu
South Korea9 sites
Sejong General Hospital
Bucheon-si
Keimyung University Dongsan Medical Center
Daegu
Asan Medical Center
Seoul
Korea University Anam Hospital
Seoul
Kyung Hee University Medical Center
Seoul
Samsung Medical Center
Seoul
Seoul National University Bundang Hospital
Seoul
Seoul National University Hospital
Seoul
Severance Hospital
Seoul
Malaysia5 sites
Hospital Sultanah Bahiyah
Alor Star
Hospital Serdang
Kajang
Sarawak Heart Center
Kota
Institut Jantung Negara - National Heart Institute
Kuala Lumpur
Sarawak Heart Centre
Kuching
Taiwan5 sites
National Taiwan University Hospital Hsin Chu Branch
Hsinchu
Kaohsing Chang Gung Memorial Hospital
Kaohsiung City
Taichung Veterans General Hospital
Taichung, 40705
National Cheng Kung University Hospital
Tainan
Chang Gung Memorial Hospital Linkou
Taoyuan City, 333
Hong Kong3 sites
Grantham Hospital
Hong Kong
Queen Elizabeth Hospital
Hong Kong
Tuen Mun Hospital
Hong Kong
Singapore3 sites
Changi General Hospital
Singapore
National University Hospital
Singapore
Tan Tock Seng Hospital
Singapore
Brunei1 site
Gleneagles Jerudong Park Medical Centre
Bandar Seri Begawan
China1 site
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai
About this study
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).
Read more
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.
- 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
- Being tested
- aCRT ON, aCRT OFF
- Medical subject headings
- Heart Failure, Bundle-Branch Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aCRT ONDevice
CRT device with AdaptivCRT enabled
aCRT OFFDevice
CRT device with AdaptivCRT disabled
| Study group | Role | What they receive |
|---|---|---|
| AdaptivCRT ON (aCRT ON, treatment group) | Experimental | 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. Receives: Device: aCRT ON |
| AdaptivCRT OFF (aCRT OFF, control group) | Active comparator | 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. Receives: Device: aCRT OFF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months post-randomization
Secondary outcomes (4)
Change in New York Heart Association (NYHA) Class
NYHA class is an ordinal variable with higher classes indicating a worse degree of heart failure:
Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.
Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.
Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest.
Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
Measured: Baseline to 6 and 12 months post-randomization
Occurrence of Hospitalizations for Worsening Heart Failure
Defined as an event requiring inpatient hospitalization or invasive intervention
Measured: 12 months post-randomization
All-cause Mortality
All-cause mortality in the aCRT ON group vs the aCRT OFF group
Measured: 12 months post-randomization
Cardiovascular-related Mortality
Defined as all cardiac deaths as well as any cardiovascular deaths that are not directly a result of mechanical or electrical heart dysfunction.
Measured: 12 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start23 Jan 2020
- Primary completion28 Mar 2024
- Study completion28 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic, Medtronic Japan Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Kazutaka Aonuma, MD, Study chair, University of Tsukuba Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180696
- Sponsor's protocol ID
- MDT18037
- Status last verified
- Apr 2025
- First submitted
- 18 Nov 2019
- Last updated
- 9 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mid-Q Response Study
- ClinicalTrials.gov ID
- NCT04180696
- Acronym / sponsor ID
- MDT18037
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic, Medtronic Japan Co., Ltd.
- Study start
- 23 Jan 2020 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 28 Mar 2024 (actual)
- First posted
- 27 Nov 2019 (actual)
- Results
- Posted 30 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| AdaptivCRT ON (aCRT ON, treatment group) | Experimental | Device: aCRT ONAdaptivCRT 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) | Active comparator | Device: aCRT OFFAdaptivCRT 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aCRT ONCRT device with AdaptivCRT enabled | Device | AdaptivCRT ON (aCRT ON, treatment group) |
| aCRT OFFCRT device with AdaptivCRT disabled | Device | AdaptivCRT OFF (aCRT OFF, control group) |
Primary outcome
Clinical Composite Score
Time frame: 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.
4 secondary outcomes
Change in New York Heart Association (NYHA) Class
Time frame: Baseline to 6 and 12 months post-randomization
Occurrence of Hospitalizations for Worsening Heart Failure
Time frame: 12 months post-randomization
All-cause Mortality
Time frame: 12 months post-randomization
Cardiovascular-related Mortality
Time frame: 12 months post-randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kazutaka Aonuma, MD study chair
University of Tsukuba Hospital
61 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aCRT ON and aCRT OFF in people with Heart Failure and Left Bundle-Branch Block, run by Medtronic Cardiac Rhythm and Heart Failure at 61 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in Japan, South Korea, Malaysia, Taiwan, Hong Kong and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Composite Score (time frame: 6 months post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.