DIAMOND AF Post-Approval Study

NCT05230524 | Terminated FDA Device

• 1 other identifier: DIAMOND AF PAS
• Study Type: observational
• Target: 84
• Locations: 3 countries
• Sites: 5

Brief Summary

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

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

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

  Estimate the 36-month freedom from AF/AFL/AT recurrence following ablation procedure using the DiamondTemp™ Ablation System.

  36 month

• Freedom from Primary Safety Events

  Estimate primary safety adverse event rate for ablation using the DiamondTemp™ Ablation System through 12 months.

  12 months

Interventions

DiamondTemp™ Ablation System DEVICE

Pulmonary vein isolation will be performed with the DiamondTemp™ Ablation System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects ≥ 18 years of age who have a recommendation for an ablation with the DiamondTemp™ Ablation System may be approached regarding enrollment in this study.

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

Sponsors & Collaborators

• Medtronic Cardiac Ablation Solutions: lead

Study Sites (5)

Florida Electrophysiology LLC

Winter Park, Florida, 32792, United States

Location

Centre Hospitalier de Pau - Hôpital François Mitterrand

Pau, 64046, France

Location

Reunion University Hospital - Saint Pierre

Saint-Pierre, 97448, France

Location

Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona

Ancona, 60030, Italy

Location

Humanitas Mater Domini

Varese, 21053, Italy

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Khaldoun Tarakji, MD

  Medtronic CAS Chief Medical Officer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 9, 2022
• Study Start: February 28, 2022
• Primary Completion: December 19, 2025
• Study Completion: December 19, 2025
• Last Updated: February 3, 2026

Record last verified: 2026-02

Locations

US (1); FR (2); IT (2)