Observational study on the DiamondTemp Ablation System for treating paroxysmal atrial fibrillation

DIAMOND AF Post-Approval Study

This study is testing the DiamondTemp Ablation System to see if it can safely help people with recurring episodes of atrial fibrillation feel better over time.

Quick facts

• Study type: Observational
• Enrollment: 225 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Medtronic Cardiac Ablation Solutions (industry)
• Locations: 8 sites (Winter Park, Florida and 7 other locations)
• Trial ID: NCT05230524 on ClinicalTrials.gov

What this trial studies

The DIAMOND AF Post Approval Study is a global, multi-center, non-randomized, single-arm observational trial aimed at evaluating the clinical performance and safety of the DiamondTemp™ Ablation System in patients with recurrent symptomatic paroxysmal atrial fibrillation. This study will assess primary efficacy over 36 months and procedural safety at 12 months, while also characterizing the ablation procedure, quality of life changes, single procedure success rates, and adverse events. Participants will be monitored for their response to the treatment and overall health outcomes throughout the study duration.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with recurrent symptomatic paroxysmal atrial fibrillation who have failed or are intolerant to at least one antiarrhythmic drug.

Not a fit: Patients with prior persistent atrial fibrillation or those who cannot comply with study procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of the DiamondTemp™ Ablation System, potentially improving treatment options for patients with paroxysmal atrial fibrillation.

How similar studies have performed: Other studies have shown success with similar ablation techniques, but this specific observational study is designed to gather post-approval data on the DiamondTemp™ Ablation System.

Eligibility criteria

Inclusion Criteria:

1. A diagnosis of recurrent symptomatic paroxysmal AF
2. Failure or intolerance of at least one Class I or III antiarrhythmic drug (including sotalol)
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 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 be completed.
3. 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
4. Patients with contraindications to a Holter monitor
5. Unwilling or unable to comply fully with study procedures and follow-up

Where this trial is running

Winter Park, Florida and 7 other locations

• Florida Electrophysiology LLC — Winter Park, Florida, United States (SUSPENDED)
• Iowa Heart Center (West Des Moines IA) — West Des Moines, Iowa, United States (WITHDRAWN)
• University of Tennessee Methodist Physicians — Memphis, Tennessee, United States (WITHDRAWN)
• Centre Hospitalier de Pau - Hôpital François Mitterrand — Pau, France (RECRUITING)
• Reunion University Hospital - Saint Pierre — Saint-Pierre Cedex, France (RECRUITING)
• Saint Lukes Hospital SA — Thessaloniki, Greece (WITHDRAWN)
• Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona — Ancona, Italy (RECRUITING)
• Humanitas Mater Domini — Varese, Italy (RECRUITING)

Study contacts

• Study coordinator: Mary Sauline

Conditions: Paroxysmal Atrial Fibrillation