Heart device study in india aims to track AF progression
NCT ID NCT04172883
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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79 people
The number who actually took part.
- Started
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Oct 2019
- Finished
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Jul 2021
- Lead sponsor
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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
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18 to 100 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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AIG hospital
Hyderabad, Telangana, India
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Apollo BGS Hospital
Mysore, Karnataka, India
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Apollo Hospital
Bhubaneswar, Odisha, India
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Apollo Hospital
Chennai, Tamil Nadu, India
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Apollo Hospital , Bannerghatta
Bangalore, Karnataka, India
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Aster Medicity
Kochi, Kerala, India
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Care Institute of medical sciences and research
Ahmedabad, Gujarat, India
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Eternal Heart Care center and Research
Jaipur, Rajasthan, India
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Fortis Escort Hospital
Mohali, Punjab, India
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Fortis Escorts Heart Institute
New Delhi, National Capital Territory of Delhi, India
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Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, 110060, India
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Other studies related to the condition(s) this trial covers.
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