DIAMOND AF Post-Approval Study

Paroxysmal Atrial Fibrillation Clinical Trial

— DAF PAS  

Official title:

DIAMOND AF Post-Approval Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05230524
• Other study ID #: DIAMOND AF PAS
• Status: Recruiting
• Start date: February 28, 2022
• Est. completion date: January 2029

Study information

• Verified date: April 2024
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: Ryan Radtke
• Phone: 712.941.9372
• Email: ryan.s.radtke[@]medtronic.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: January 2029
• Est. primary completion date: January 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 de novo pulmonary vein isolation (PVI) procedure 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. Prior left atrial ablation or left atrial surgical procedure

3. Patient with life expectancy that makes it unlikely 36 months of follow-up will be completed.

4. 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

5. Patients with contraindications to a Holter monitor

6. Unwilling or unable to comply fully with study procedures and follow-up

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Countries where clinical trial is conducted

United States,  France,  Greece,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Freedom from Primary Safety Events	Estimate primary safety adverse event rate for ablation using the DiamondTemp™ Ablation System through 12 months.	12 months