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CompletedNCT04180696Updated Jul 9, 2025Results posted

Mid-Q Response Study

An interventional study of aCRT ON and aCRT OFF in Heart Failure, Left Bundle-Branch Block and Heart Failure With Reduced Ejection Fraction (HFrEF), sponsored by Medtronic Cardiac Rhythm and Heart Failure. Completed at 61 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-09.

Sponsored by Medtronic Cardiac Rhythm and Heart Failure (part of Medtronic) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
177
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • 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
03

In context

Heart Failure

6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.

This study's enrollment of 177 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure is the lead sponsor of 240 studies on the registry; 4 are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 18 (95%) have results posted.

Browse Medtronic Cardiac Rhythm and Heart Failure studies →All Medtronic studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subject is willing to sign and date the study 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 (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 ≤35% (documented within 180 days prior to enrollment).
  • Subject has 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

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 due to non-cardiac causes that would not allow completion of the study.
  • Subject is pregnant (if required by local law, women of must undergo a pregnancy test within seven days prior to device implant).
  • Subject meets any exclusion criteria required by local law.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
177 participants (actual)

Study arms

  • Experimental
    AdaptivCRT ON (aCRT ON, treatment group)

    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.

    Device: aCRT ON

  • Active comparator
    AdaptivCRT OFF (aCRT OFF, control group)

    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.

    Device: aCRT OFF

Interventions

  • DeviceaCRT ON

    CRT device with AdaptivCRT enabled

  • DeviceaCRT OFF

    CRT device with AdaptivCRT disabled

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months post-randomization

Secondary outcomes

  1. 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.

    Time frame: Baseline to 6 and 12 months post-randomization

  2. Occurrence of Hospitalizations for Worsening Heart Failure

    Defined as an event requiring inpatient hospitalization or invasive intervention

    Time frame: 12 months post-randomization

  3. All-cause Mortality

    All-cause mortality in the aCRT ON group vs the aCRT OFF group

    Time frame: 12 months post-randomization

  4. 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.

    Time frame: 12 months post-randomization

07

Results

Posted May 30, 2025

Participant flow

The study was multicentric and in a hospital setting, patients selected were heart failure patients in Asian countries indicated for CRT per local guidelines with moderately wide QRS (duration ≥120ms and \<150ms), preserved AV conduction (PR interval ≤ 200 ms), along with a Left bundle branch block (LBBB).

Participant flow — Overall Study
MilestoneAdaptivCRT ON (aCRT ON, Treatment Group)AdaptivCRT OFF (aCRT OFF, Control Group)
Started8685
Completed8078
Not completed67
Withdrew: Death56
Withdrew: Lost to follow-up10
Withdrew: Withdrawal by subject01

Outcome measures

PrimaryClinical 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.

Time frame:
6 months post-randomization
Reported as:
Count of participants · Participants
Clinical Composite Score
ParticipantsAdaptivCRT ON (aCRT ON, Treatment Group)AdaptivCRT OFF (aCRT OFF, Control Group)
Improved6668
Unchanged1011
Worsened106
Statistical analysis
  • AdaptivCRT ON (aCRT ON, Treatment Group) vs AdaptivCRT OFF (aCRT OFF, Control Group) · Chi-squared · p = 0.61
SecondaryChange 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.

Time frame:
Baseline to 6 and 12 months post-randomization
Reported as:
Count of participants · Participants
Change in New York Heart Association (NYHA) Class
ParticipantsAdaptivCRT ON (aCRT ON, Treatment Group)AdaptivCRT OFF (aCRT OFF, Control Group)
Baseline — Class I11
Baseline — Class II3031
Baseline — Class III/IV5553
Baseline — Not reported00
3 Month — Class I2422
3 Month — Class II4953
3 Month — Class III/IV114
3 Month — Not reported26
6 Month — Class I2327
6 Month — Class II5052
6 Month — Class III/IV113
6 Month — Not reported23
12 Month — Class I3532
12 Month — Class II4142
12 Month — Class III/IV89
12 Month — Not reported22
Statistical analysis
  • AdaptivCRT ON (aCRT ON, Treatment Group) vs AdaptivCRT OFF (aCRT OFF, Control Group) · Regression, Logistic · p = 0.63 · Odds ratio (or): 1.192 · 95% CI 0.579 to 2.455Proportional odds logistic regression model. Baseline NYHA class and time included as fixed covariates.
SecondaryOccurrence of Hospitalizations for Worsening Heart Failure

Defined as an event requiring inpatient hospitalization or invasive intervention

Time frame:
12 months post-randomization
Reported as:
Count of participants · Participants
Occurrence of Hospitalizations for Worsening Heart Failure
ParticipantsAdaptivCRT ON (aCRT ON, Treatment Group)AdaptivCRT OFF (aCRT OFF, Control Group)
Occurrence of Hospitalizations for Worsening Heart Failure108
Statistical analysis
  • AdaptivCRT ON (aCRT ON, Treatment Group) vs AdaptivCRT OFF (aCRT OFF, Control Group) · Regression, Cox · p = 0.64 · Hazard ratio (hr): 1.250 · 95% CI 0.492 to 3.175Adjusted for NYHA class and sex.
SecondaryAll-cause Mortality

All-cause mortality in the aCRT ON group vs the aCRT OFF group

Time frame:
12 months post-randomization
Reported as:
Count of participants · Participants
All-cause Mortality
ParticipantsAdaptivCRT ON (aCRT ON, Treatment Group)AdaptivCRT OFF (aCRT OFF, Control Group)
All-cause Mortality56
Statistical analysis
  • AdaptivCRT ON (aCRT ON, Treatment Group) vs AdaptivCRT OFF (aCRT OFF, Control Group) · Log Rank · p = 0.78
SecondaryCardiovascular-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.

Time frame:
12 months post-randomization
Reported as:
Count of participants · Participants
Cardiovascular-related Mortality
ParticipantsAdaptivCRT ON (aCRT ON, Treatment Group)AdaptivCRT OFF (aCRT OFF, Control Group)
Cardiovascular-related Mortality33
Statistical analysis
  • AdaptivCRT ON (aCRT ON, Treatment Group) vs AdaptivCRT OFF (aCRT OFF, Control Group) · Regression, Cox · p = 0.98 · Hazard ratio (hr): 1.020 · 95% CI 0.206 to 5.056

Adverse events

Collected over The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
AdaptivCRT ON (aCRT ON, Treatment Group)5/86 (5.8%)27/86 (31.4%)8/86 (9.3%)
AdaptivCRT OFF (aCRT OFF, Control Group)6/85 (7.1%)24/85 (28.2%)14/85 (16.5%)
Most frequent serious events
Showing 10 of 58
Most frequent serious events
EventAdaptivCRT ON (aCRT ON, Treatment Group)AdaptivCRT OFF (aCRT OFF, Control Group)
Cardiac failureCardiac disorders7/867/85
Lead dislodgementProduct Issues3/860/85
Ventricular tachycardiaCardiac disorders1/862/85
COVID-19Infections and infestations0/862/85
PneumoniaInfections and infestations0/862/85
Atrial fibrillationCardiac disorders2/861/85
Mitral valve incompetenceCardiac disorders2/860/85
AppendicitisInfections and infestations2/860/85
AnaemiaBlood and lymphatic system disorders0/861/85
Cardiac arrestCardiac disorders0/861/85
Most frequent other events
Most frequent other events
EventAdaptivCRT ON (aCRT ON, Treatment Group)AdaptivCRT OFF (aCRT OFF, Control Group)
Device stimulation issueProduct Issues3/867/85
Cardiac failureCardiac disorders1/863/85
Atrial fibrillationCardiac disorders3/861/85
Ventricular extrasystolesCardiac disorders0/861/85
Ventricular tachycardiaCardiac disorders1/861/85
Implant site painGeneral disorders0/861/85
Medical device site painGeneral disorders0/861/85
PneumothoraxRespiratory, thoracic and mediastinal disorders0/861/85
Tricuspid valve incompetenceCardiac disorders1/860/85
Implant site infectionInfections and infestations1/860/85

Baseline characteristics

Number of subjects randomized following successful implant

Age, Continuous
Age, Continuous(years)AdaptivCRT ON (aCRT ON, Treatment Group)AdaptivCRT OFF (aCRT OFF, Control Group)Total
Mean67.0 ± 11.365.8 ± 13.766.4 ± 12.5
Sex: Female, Male
Sex: Female, Male(Participants)AdaptivCRT ON (aCRT ON, Treatment Group)AdaptivCRT OFF (aCRT OFF, Control Group)Total
Female292554
Male5760117
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)AdaptivCRT ON (aCRT ON, Treatment Group)AdaptivCRT OFF (aCRT OFF, Control Group)Total
Count of participants——0
NYHA class
NYHA class(Participants)AdaptivCRT ON (aCRT ON, Treatment Group)AdaptivCRT OFF (aCRT OFF, Control Group)Total
NYHA class I112
NYHA class II303161
NYHA class IIII524799
NYHA class IV369
LVEF
LVEF(percent)AdaptivCRT ON (aCRT ON, Treatment Group)AdaptivCRT OFF (aCRT OFF, Control Group)Total
Mean27.0 ± 6.625.2 ± 6.526.1 ± 6.6
QRS duration
QRS duration(ms)AdaptivCRT ON (aCRT ON, Treatment Group)AdaptivCRT OFF (aCRT OFF, Control Group)Total
Mean136.9 ± 9.4136.1 ± 9.0136.5 ± 9.2
PR interval
PR interval(ms)AdaptivCRT ON (aCRT ON, Treatment Group)AdaptivCRT OFF (aCRT OFF, Control Group)Total
Mean173.2 ± 21.0174.3 ± 21.4173.7 ± 21.1
08

Study locations

61 sites
  • Gleneagles Jerudong Park Medical Centre
    Bandar Seri Begawan, Brunei
  • Ruijin Hospital Shanghai Jiao Tong University School of Medicine
    Shanghai, China
  • Grantham Hospital
    Hong Kong, Hong Kong
  • Queen Elizabeth Hospital
    Hong Kong, Hong Kong
  • Tuen Mun Hospital
    Hong Kong, Hong Kong
  • National Cardiovascular Center Harapan Kita
    Jakarta, 11420, Indonesia
  • 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
    Hyōgo, 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, Japan
  • Hospital Sultanah Bahiyah
    Alor Star, Malaysia
  • Hospital Serdang
    Kajang, Malaysia
  • Sarawak Heart Center
    Kota, Malaysia
  • Institut Jantung Negara - National Heart Institute
    Kuala Lumpur, Malaysia
  • Sarawak Heart Centre
    Kuching, Malaysia
  • Makati Medical Center
    Makati, Philippines
  • Changi General Hospital
    Singapore, Singapore
  • National University Hospital
    Singapore, Singapore
  • Tan Tock Seng Hospital
    Singapore, Singapore
  • Sejong General Hospital
    Bucheon-si, South Korea
  • Keimyung University Dongsan Medical Center
    Daegu, South Korea
  • Asan Medical Center
    Seoul, South Korea
  • Korea University Anam Hospital
    Seoul, South Korea
  • Kyung Hee University Medical Center
    Seoul, South Korea
  • Samsung Medical Center
    Seoul, South Korea
  • Seoul National University Bundang Hospital
    Seoul, South Korea
  • Seoul National University Hospital
    Seoul, South Korea
  • Severance Hospital
    Seoul, South Korea
  • National Taiwan University Hospital Hsin Chu Branch
    Hsinchu, Taiwan
  • Kaohsing Chang Gung Memorial Hospital
    Kaohsiung City, Taiwan
  • Taichung Veterans General Hospital
    Taichung, 40705, Taiwan
  • National Cheng Kung University Hospital
    Tainan, Taiwan
  • Chang Gung Memorial Hospital Linkou
    Taoyuan City, 333, Taiwan
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2020 to primary completion in Mar 2024, 50 months.

Results were first posted in May 2025, 1 year 2 months after primary completion.

Of 236 industry-sponsored interventional studies with no phase under Heart Failure, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 62. This study's 50 months is above that.

Counting every sponsor, half of 1,354 studies reached it within 31 months; a quarter within 16 and three quarters within 52.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 18, 2019
First posted
Nov 27, 2019
StartActual
Jan 23, 2020
Primary completionActual
Mar 28, 2024
CompletionActual
Mar 28, 2024
Results first posted
May 30, 2025
Last update
Jul 9, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04180696
Lead sponsor
Medtronic Cardiac Rhythm and Heart Failure
Collaborators
Medtronic, Medtronic Japan Co., Ltd.
Responsible party
Sponsor
First posted
Nov 27, 2019
Start date
Jan 23, 2020
Primary completion
Mar 28, 2024
Completion
Mar 28, 2024
Results posted
May 30, 2025
Last update
Jul 9, 2025

Study contacts

Kazutaka Aonuma, MD
study chair · University of Tsukuba Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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