AF Ablation Devices Need Randomized Trials, Advisory Panel Tells FDA
This article was originally published in The Gray Sheet
Executive Summary
An FDA advisory panel is encouraging the agency to continue requiring randomized controlled trials of atrial fibrillation ablation devices while allowing sponsors to relax the trials' inclusion criteria
You may also be interested in...
Draft Guidance: Non-Randomized Trials OK For AFib Surgical Ablation Devices
Studies other than randomized controlled trials can support approval for surgical ablation devices to treat atrial fibrillation, FDA affirms in a Sept. 14 1draft guidance
Draft Guidance: Non-Randomized Trials OK For AFib Surgical Ablation Devices
Studies other than randomized controlled trials can support approval for surgical ablation devices to treat atrial fibrillation, FDA affirms in a Sept. 14 1draft guidance
Experts Discuss Lessons From A-Fib Ablation Trials At Boston Meeting
FDA will likely require future trials of atrial fibrillation (AF) ablation catheters to use an approved ablation catheter instead of antiarrhythmic drugs as the studies' control, experts suggested at the Boston Symposium on Atrial Fibrillation Jan. 15-17