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Heart device study in india aims to track AF progression

NCT ID NCT04172883

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how Medtronic heart devices detect and manage atrial fibrillation (AF) in Indian patients. It tracked whether the condition became persistent over time. The study enrolled 79 people over 55 with heart devices. It was terminated early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

79 people

The number who actually took part.

Started

Oct 2019

Finished

Jul 2021

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1 Subject is implanted with a Medtronic cardiac implantable device with an atrial lead equipped with atrial ATP therapies (rATP) enabled no longer than 18 months and at the minimum 6 weeks has passed since the implant; 2. Age \> 55 years; 3. Subject provides informed consent; 4. Subject is willing and able to comply with the study procedures; 5. Subject has documented history of atrial fibrillation or atrial flutter, or one or more of the risk factors for developing AF as per AHA/HRS (American heart Association/Heart rhythm Society) guidelines. * Age \> 60 years; * Stroke/TIA (Transient ischemic Attack); * Diabetes; * High Blood Pressure; * Coronary artery disease; * Cardiomyopathy; * Pericardial inflammation; * Prior heart attacks; * Congestive heart failure; * Structural heart disease (valve problems or congenital defects); * Prior open-heart surgery; * Untreated atrial flutter (another type of abnormal heart rhythm); * Thyroid disease; * Chronic lung disease; * Sleep apnea; * Excessive alcohol use; * Serious illness or infection. Exclusion criteria: Patients are not eligible to be enrolled in the study if any of the following criteria is met: 1. Subject has been implanted with a Medtronic cardiac implantable device with an atrial lead equipped with atrial ATP therapies (rATP) enabled for more than 18 months; 2. Subject is in permanent AF or persistent AF at the baseline visit: 1. The definition of permanent AF will be based on the physicians' decision that nothing further can be done to cardiovert the patient or, in historical cases, the investigators will refer to the Cardiac Compass reports: 2. The definition of persistent AF at baseline will refer to the Cardiac Compass reports (\>7 consecutive days in AF with the last day being the day of enrollment) 3. Participation in other studies which could potentially conflict with this study; 4. Legal incapacity or evidence that a subject cannot understand the purpose and risks of the study or inability to comply fully with study procedures and follow up.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • AIG hospital

    Hyderabad, Telangana, India

  • Apollo BGS Hospital

    Mysore, Karnataka, India

  • Apollo Hospital

    Bhubaneswar, Odisha, India

  • Apollo Hospital

    Chennai, Tamil Nadu, India

  • Apollo Hospital , Bannerghatta

    Bangalore, Karnataka, India

  • Aster Medicity

    Kochi, Kerala, India

  • Care Institute of medical sciences and research

    Ahmedabad, Gujarat, India

  • Eternal Heart Care center and Research

    Jaipur, Rajasthan, India

  • Fortis Escort Hospital

    Mohali, Punjab, India

  • Fortis Escorts Heart Institute

    New Delhi, National Capital Territory of Delhi, India

  • Sir Ganga Ram Hospital

    New Delhi, National Capital Territory of Delhi, 110060, India

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