NCT03334630

DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation

A Randomized Controlled Clinical Evaluation of the DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 482 (actual)
• Sponsor: Medtronic Cardiac Ablation Solutions · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the DIAMOND-AF study is to establish the safety and effectiveness of the DiamondTemp System for the treatment of drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation in patients.

Detailed description

The DIAMOND-AF study is a prospective, single blind, 1:1 randomized controlled study being performed at multiple centers in the United States, Canada and Europe. The study will evaluate the safety and effectiveness of the DiamondTemp System used for ablation in patients with paroxysmal atrial fibrillation (AF). Subjects will be randomized for treatment with either the DiamondTemp Ablation Catheter or the TactiCath™ Quartz Contact Force Ablation Catheter manufactured by Abbott. Patients will be followed for 12 months.

Conditions

• Paroxysmal Atrial Fibrillation
• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	DiamondTemp Ablation catheter	a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
DEVICE	TactiCath Quartz Ablation catheter	a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter

Timeline

• Start date: 2017-11-06
• Primary completion: 2019-11-18
• Completion: 2019-12-03
• First posted: 2017-11-07
• Last updated: 2025-02-13
• Results posted: 2020-12-09

Locations

23 sites across 5 countries: United States, Canada, Czechia, France, Italy

Regulatory

• FDA-regulated device study