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DIAMOND AF Post-Approval Study — DAF PAS  

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:
DIAMOND AF Post-Approval Study

Clinical Trial Summary

The DIAMOND AF Post Approval study is a prospective, global, multi-center, non-randomized, single-arm observational trial

Clinical Trial Description

The DIAMOND AF PAS is a prospective, global, multi-center, non-randomized, single-arm observational trial. This post approval study is a condition of the Pre-Market Approval order (P200028/S002) by the U.S. Food and Drug Administration." The purpose of this clinical study is to describe clinical performance and safety data in a broad patient population treated with the DiamondTemp™ Ablation System. To assess clinical performance and safety of the DiamondTemp™ Ablation System, study objectives will estimate primary efficacy through 36 months, and primary procedural safety at 12 months. Additionally, study objectives will characterize the ablation procedure, change in QoL through 36 months, single procedure success rate, freedom from symptomatic recurrence, and adverse events (AE) through 36 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05230524
Study type Observational
Source Medtronic Cardiac Rhythm and Heart Failure
Contact Ryan Radtke
Phone 712.941.9372
Email ryan.s.radtke@medtronic.com
Status Recruiting
Phase
Start date February 28, 2022
Completion date January 2029
View Details
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