DIAMOND AF Post-Approval Study

Last updated: April 8, 2025
Sponsor: Medtronic Cardiac Ablation Solutions
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dysrhythmia

Chest Pain

Arrhythmia

Treatment

DiamondTemp™ Ablation System

Clinical Study ID

NCT05230524
DIAMOND AF PAS
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. A diagnosis of recurrent symptomatic paroxysmal AF

  2. Failure or intolerance of at least one Class I or III antiarrhythmic drug (includingsotalol)

  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

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 becompleted.

  3. Current or anticipated participation in any other clinical trial of a drug, deviceor 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

Total Participants: 225
Treatment Group(s): 1
Primary Treatment: DiamondTemp™ Ablation System
Phase:
Study Start date:
February 28, 2022
Estimated Completion Date:
January 31, 2029

Study 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.

Connect with a study center

  • Centre Hospitalier de Pau - Hôpital François Mitterrand

    Pau, 64046
    France

    Active - Recruiting

  • Reunion University Hospital - Saint Pierre

    Saint-Pierre Cedex, 97448
    France

    Active - Recruiting

  • Saint Lukes Hospital SA

    Thessaloniki, 552 36
    Greece

    Site Not Available

  • Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona

    Ancona, 60030
    Italy

    Active - Recruiting

  • Humanitas Mater Domini

    Varese, 21053
    Italy

    Active - Recruiting

  • Florida Electrophysiology LLC

    Winter Park, Florida 32792
    United States

    Suspended

  • Iowa Heart Center (West Des Moines IA)

    West Des Moines, Iowa 50266
    United States

    Site Not Available

  • University of Tennessee Methodist Physicians

    Memphis, Tennessee 38104
    United States

    Site Not Available

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