DIAMOND AF Post-Approval Study (DAF PAS)

July 1, 2026 updated by: Medtronic Cardiac Ablation Solutions
The DIAMOND AF Post Approval study is a prospective, global, multi-center, non-randomized, single-arm observational trial

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 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.

Study Type

Observational

Enrollment (Actual)

84

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pau, France, 64046
        • Centre Hospitalier de Pau - Hôpital François Mitterrand
      • Saint-Pierre, France, 97448
        • Reunion University Hospital - Saint Pierre
  • Italy
      • Ancona, Italy, 60030
        • Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona
      • Varese, Italy, 21053
        • Humanitas Mater Domini
  • United States
    • Florida
      • Winter Park, Florida, United States, 32792
        • Florida Electrophysiology LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from Atrial Fibrillation (AF) /Atrial Flutter (AFL) /Atrial Tachycardia (AT)
Time Frame: 36 month
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
Time Frame: 12 months
Estimate primary safety adverse event rate for ablation using the DiamondTemp™ Ablation System through 12 months.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Ablation Solutions

Investigators

  • Study Director: Khaldoun Tarakji, MD, Medtronic CAS Chief Medical Officer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2022

Primary Completion (Actual)

December 17, 2025

Study Completion (Actual)

December 17, 2025

Study Registration Dates

First Submitted

January 27, 2022

First Submitted That Met QC Criteria

January 28, 2022

First Posted (Actual)

February 9, 2022

Study Record Updates

Last Update Posted (Actual)

July 6, 2026

Last Update Submitted That Met QC Criteria

July 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIAMOND AF PAS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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