Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Atrial Fibrillation
Type
Interventional
Phase
Phase 4
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

This is a multicenter trial to evaluate the impact of treatment with dapagliflozin versus placebo following catheter ablation of AF on the burden of AF during 12 months of follow-up. This prospective, randomized, multicenter, placebo-controlled trial aims to enroll 100 subjects with AF (paroxysmal o...

This is a multicenter trial to evaluate the impact of treatment with dapagliflozin versus placebo following catheter ablation of AF on the burden of AF during 12 months of follow-up. This prospective, randomized, multicenter, placebo-controlled trial aims to enroll 100 subjects with AF (paroxysmal or persistent) who are scheduled to undergo catheter ablation of patients. All enrolled subjects will be required to have a cardiac implantable electronic device (CIED) capable of assessing the burden of AF. Following catheter ablation for AF and functional CIED subjects will be randomized to treatment with dapagliflozin 10 mg once daily versus placebo. The primary endpoint for the trial will be AF burden assessed at 12 months following catheter ablation of AF. We expect that each participating site will enroll a 12-14 patients during a 24-month period. The Investigational Drug Services at the University of Rochester will be in charge of dispensing all study related drugs to subject.

Tracking Information

NCT #
NCT04792190
Collaborators
AstraZeneca
Investigators
Principal Investigator: Mehmet Aktas Principal Investigator
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