NCT05230524

DIAMOND AF Post-Approval Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 84 (actual)
• Sponsor: Medtronic Cardiac Ablation Solutions · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Paroxysmal Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	DiamondTemp™ Ablation System	Pulmonary vein isolation will be performed with the DiamondTemp™ Ablation System

Timeline

• Start date: 2022-02-28
• Primary completion: 2025-12-17
• Completion: 2025-12-17
• First posted: 2022-02-09
• Last updated: 2026-04-07

Locations

5 sites across 3 countries: United States, France, Italy

Regulatory

• FDA-regulated device study