Health Condition 1: I481- Persistent atrial fibrillation
Conditions
Interventions
Intervention1: Reactive-ATP: Reactive ATP (rATP) is a feature available in the implanted device for this group of pts . There is no set frequency with which it acts , its based on the identification o
Sponsors
India Medtronic Pvt Ltd
Eligibility
Inclusion criteria
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 guidelines. [26]. o Age > 60 years; o Stroke/TIA; o Diabetes; o High Blood Pressure; o Coronary artery disease; o Cardiomyopathy; o Pericardial inflammation; o Prior heart attacks; o Congestive heart failure; o Structural heart disease (valve problems or congenital defects); o Prior open-heart surgery; o Untreated atrial flutter (another type of abnormal heart rhythm); o Thyroid disease; o Chronic lung disease; o Sleep apnea; o Excessive alcohol use; o Serious illness or infection.
Exclusion criteria
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: a. The definition of permanent AF will be based on the physiciansâ?? decision that nothing further can be done to cardiovert the patient or, in historical cases, we will refer to the Cardiac Compass reports: b. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to persistent AF, defined as more than 7 consecutive days of AF, retrieved by using the device AT/AF diagnostics, or time to permanent AF. Time 0 for the time to event calculation is defined as the enrollment date or the first day in sinus rhythm after enrollmentTimepoint: 3.5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the two atrial ATP Programming arms in terms of clinical endpoints reported below, all-cause death (at the end of 24 months);cardiovascular hospitalization (HF, AF or other), measured as time to first event and annual rate, Annual rate for all-cause hospitalization; AT/AF burden metrics, measured in terms of time to first event (daily burden â?¥1 day, â?¥2 days, â?¥30 days) or the ratio between time in AT/AF and the observation period; Timepoint: 3.5 years | — |
Countries
India
Contacts
Public ContactVinay Rajan
India Medtronic Pvt Ltd
Outcome results
None listed