DIAMOND AF Post-Approval Study

Recruiting

• Conditions: Paroxysmal Atrial Fibrillation

• Registration Number: NCT05230524
• Lead Sponsor: Medtronic Cardiac Ablation Solutions

Brief 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.

Study Timeline

• Study First Submitted: 2022-01-27
• Study First Submitted QC: 2022-01-28
• Study First Posted: 2022-02-09
• Study Start: 2022-02-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-10
• Primary Completion: 2029-01
• Study Completion: 2029-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

1. A diagnosis of recurrent symptomatic paroxysmal AF
2. Failure or intolerance of at least one Class I or III antiarrhythmic drug (including sotalol)
3. Patient is ≥ 18 years of age
4. Planned procedure for the treatment of AF using commercially available DiamondTemp™ Ablation System
5. Patient is willing and able to provide written informed consent
6. Patient is willing and able to comply with study requirements

Exclusion Criteria

1. Prior persistent AF (continuous AF that is sustained >7 days)
2. Patient with life expectancy that makes it unlikely 36 months of follow-up will be completed.
3. Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study not pre-approved by Medtronic
4. Patients with contraindications to a Holter monitor
5. Unwilling or unable to comply fully with study procedures and follow-up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Freedom from Atrial Fibrillation (AF) /Atrial Flutter (AFL) /Atrial Tachycardia (AT)	36 month	Estimate the 36-month freedom from AF/AFL/AT recurrence following ablation procedure using the DiamondTemp™ Ablation System.
Freedom from Primary Safety Events	12 months	Estimate primary safety adverse event rate for ablation using the DiamondTemp™ Ablation System through 12 months.

Trial Locations

Locations (8)

Florida Electrophysiology LLC; 🇺🇸 Winter Park, Florida, United States

Iowa Heart Center (West Des Moines IA); 🇺🇸 West Des Moines, Iowa, United States

University of Tennessee Methodist Physicians; 🇺🇸 Memphis, Tennessee, United States

Centre Hospitalier de Pau - Hôpital François Mitterrand; 🇫🇷 Pau, France

Reunion University Hospital - Saint Pierre; 🇫🇷 Saint-Pierre Cedex, France

Saint Lukes Hospital SA; 🇬🇷 Thessaloniki, Greece

Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona; 🇮🇹 Ancona, Italy

Humanitas Mater Domini; 🇮🇹 Varese, Italy