NCT03643224

DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation

A Prospective Clinical Evaluation of the DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 376 (actual)
• Sponsor: Medtronic Cardiac Ablation Solutions · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the Diamond-AF II study is to establish the safety and effectiveness of the DiamondTemp Ablation System for the treatment of drug refractory, symptomatic persistent atrial fibrillation in patients.

Detailed description

The DIAMOND-AF II Study is a prospective, non-randomized (single-group assignment) trial being performed at multiple centers in the United States, Canada and Europe to evaluate the safety and effectiveness of the DiamondTemp Ablation System for the treatment of patients with persistent atrial fibrillation.

Conditions

• Persistent Atrial Fibrillation
• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Radiofrequency Ablation	A procedure will be performed using a radiofrequency ablation catheter.

Timeline

• Start date: 2018-09-19
• Primary completion: 2024-10-31
• Completion: 2024-10-31
• First posted: 2018-08-22
• Last updated: 2025-10-23
• Results posted: 2025-10-23

Locations

28 sites across 6 countries: United States, Canada, Czechia, France, Germany, Italy

Regulatory

• FDA-regulated device study