NCT04172883

Management of Device Detected AT and Impact of Device Treatment Algorithms on Atrial Fibrillation

Management of Device Detected Atrial Tachyarrhythmia( AT) and Impact of Device Treatment Algorithms on Atrial Fibrillation (AF) in Indian Population

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The MANDATE-AF study was designed to address evidence needs in India for device-based management of AF using AT/AF (Atrial Tachycardia/Atrial fibrillation) diagnostic features and therapies such as Reactive Atrial anti tachycardia Pacing (rATP) within Medtronic Cardiac Implantable Electronic Devices (CIED)and its impact on the time to persistent AF and progression of AT/AF.

Detailed description

New generation Cardiac Implantable Electronic devices (CIED's)such as Pacemakers, Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy (CRT) has diagnostic and treatment delivery features which helps in slowing the progression of Atrial Fibrillation. A Study conducted in Europe, called the MINERVA Trial, showed the efficacy of a feature within Medtronic CIED's called (rATP)™, in the termination of abnormal rhythms by pacing stimuli, and clinical benefit in reducing incidence of Atrial Fibrillation. However, there is dearth of local evidence of this within the Indian population and also a need to show that turning on rATP does not compromise on battery depletion. The MANDATE-AF study is a prospective , Interventional , Randomized, single blind study aiming to show that a reduced sequence programming of this rATP therapy ,can improve device battery longevity and is as effective as the Minerva trial ATP programming when it comes to showing its impact on time to persistent AF and on the progression of AT/AF within the Indian population. The study analyses patients implanted with a Medtronic cardiac implantable device with an atrial lead and equipped with atrial ATP therapies. The patients will be randomized into two groups: * an interventional arm including patients with a conservative atrial ATP therapies programming setting * a control, arm including patients with the same atrial ATP therapies programming setting adopted in the Minerva Trial Cardiovascular events will be collected prospectively for at least 24 months after enrollment. Physicians will be recommended to schedule in clinic follow-up visits every 6 months and remote follow-up visits every 3 months in between. Every patient will be followed for at least 24 months, until the last patient enrolled exits the study.

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
OTHER	Treatment arm	All pts are implanted with rATP enabled devices prior to the study start , the only intervention in both arms is switching on rATP and in the treatment arm programming changes done to optimize the rATP sequence delivery of therapy and prevent the patient from going into permanent or persistent AF

Timeline

• Start date: 2019-10-01
• Primary completion: 2021-07-15
• Completion: 2021-07-28
• First posted: 2019-11-21
• Last updated: 2026-02-27
• Results posted: 2026-02-27

Locations

11 sites across 1 country: India