Status:
ACTIVE_NOT_RECRUITING
DIAMOND AF Post-Approval Study
Lead Sponsor:
Medtronic Cardiac Ablation Solutions
Conditions:
Paroxysmal Atrial Fibrillation
Eligibility:
All Genders
18+ years
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 th...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 28 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT05230524
Start Date
February 28 2022
End Date
January 1 2026
Last Update
November 13 2025
Active Locations (5)
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1
Florida Electrophysiology LLC
Winter Park, Florida, United States, 32792
2
Centre Hospitalier de Pau - Hôpital François Mitterrand
Pau, France, 64046
3
Reunion University Hospital - Saint Pierre
Saint-Pierre, France, 97448
4
Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona
Ancona, Italy, 60030