Clinical trial NCT05230524: DIAMOND AF Post-Approval Study
Official title: DIAMOND AF Post-Approval Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: Medtronic Cardiac Ablation Solutions
Sponsor class: INDUSTRY
First posted: 2022-02-09
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

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

Primary outcomes:
measure: Freedom from Atrial Fibrillation (AF) /Atrial Flutter (AFL) /Atrial Tachycardia (AT)
timeFrame: 36 month
measure: Freedom from Primary Safety Events
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Winter Park
country: United States
facility: Florida Electrophysiology LLC
state: Florida
city: West Des Moines
country: United States
facility: Iowa Heart Center (West Des Moines IA)
state: Iowa
city: Memphis
country: United States
facility: University of Tennessee Methodist Physicians
state: Tennessee
city: Pau
country: France
facility: Centre Hospitalier de Pau - Hôpital François Mitterrand
city: Saint-Pierre Cedex
country: France
facility: Reunion University Hospital - Saint Pierre
city: Thessaloniki
country: Greece
facility: Saint Lukes Hospital SA
city: Ancona
country: Italy
facility: Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona
city: Varese
country: Italy
facility: Humanitas Mater Domini
Study officials:
affiliation: Medtronic CAS Chief Medical Officer
name: Khaldoun Tarakji, MD
role: STUDY_DIRECTOR
References: