TerminatedNot Applicable

DIAMOND AF Post-Approval Study

Stopped: Sponsor and FDA agreed on early termination.

United States, France, Italy84 participantsStarted 2022-02-28

Plain-language summary

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

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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

Freedom from Atrial Fibrillation (AF) /Atrial Flutter (AFL) /Atrial Tachycardia (AT)

Timeframe: 36 month

Freedom from Primary Safety Events

Timeframe: 12 months

NCT IDNCT05230524

SponsorMedtronic Cardiac Ablation Solutions

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-12-17