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DIAMOND AF Post-Approval Study

NCT ID: NCT05230524

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

225 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-28

Study Completion Date

2026-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Paroxysmal Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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DiamondTemp™ Ablation System

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Cardiac Ablation Solutions

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Khaldoun Tarakji, MD

Role: STUDY_DIRECTOR

Medtronic CAS Chief Medical Officer

Locations

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Florida Electrophysiology LLC

Winter Park, Florida, United States

Site Status

Centre Hospitalier de Pau - Hôpital François Mitterrand

Pau, , France

Site Status

Reunion University Hospital - Saint Pierre

Saint-Pierre, , France

Site Status

Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona

Ancona, , Italy

Site Status

Humanitas Mater Domini

Varese, , Italy

Site Status

Countries

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Greece United States France Italy

Other Identifiers

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DIAMOND AF PAS

Identifier Type: -

Identifier Source: org_study_id