DIAMOND AF Post-Approval Study

Stopped early

Conditions studied: Paroxysmal Atrial Fibrillation

In brief

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

Key facts

Study ID

NCT05230524

Run by

Medtronic Cardiac Ablation Solutions

People needed

84

Starts

2022-02-28

Expected to finish

2025-12-17

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Prior persistent AF (continuous AF that is sustained >7 days)
• Patient with life expectancy that makes it unlikely 36 months of follow-up will be completed.
• 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
• Patients with contraindications to a Holter monitor
• Unwilling or unable to comply fully with study procedures and follow-up

Where it is running

• Florida Electrophysiology LLC — Winter Park, Florida, United States
• Centre Hospitalier de Pau - Hôpital François Mitterrand — Pau, France
• Reunion University Hospital - Saint Pierre — Saint-Pierre, France
• Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona — Ancona, Italy
• Humanitas Mater Domini — Varese, Italy

Full record on ClinicalTrials.gov

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