STOP AF First Post-Approval Study

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:

STOP AF First Post-Approval Study, an Addendum to the Cryo Global Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05227053
• Other study ID #: STOP AF First PAS
• Status: Recruiting
• Start date: April 28, 2022
• Est. completion date: January 2028

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 STOP AF First PAS is a prospective, global, multi-center, observational trial.

Description:

The STOP AF First Post Approval Study (PAS) is a sub-study to the Cryo Global Registry. The STOP AF First PAS is a prospective, global, multi-center, observational trial. The purpose of the study is to describe long-term clinical performance and safety data in the recurrent symptomatic paroxysmal AF population treated with Arctic Front™ and Freezor™ MAX Families of cardiac cryoablation catheters (hereafter referred to as Arctic Front™ Cardiac Cryoablation Catheter System) as an alternative to antiarrhythmic drug therapy as an initial rhythm control strategy. This PAS is a condition of the pre-market approval order (P100010/S110) by the U.S. Food and Drug Administration.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 2028
• Est. primary completion date: January 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject has been diagnosed with symptomatic paroxysmal AF

• Subject is = 18 years of age or minimum age as required by local regulations

• Planned pulmonary vein isolation (PVI) procedure using the commercially available Arctic Front™ cardiac cryoablation catheter System at least 7 calendar days post study enrollment to allow for pre-ablation baseline data collection from sensor device

• Willing to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements

Exclusion Criteria:

• History of AF treatment with class I or III antiarrhythmic drug (AAD), including sotalol, with the intention to prevent an AF recurrence. However, patients pretreated with above AAD for less than 7 days prior to planned PVI procedure or with the intention to convert an AF episode are allowed.

• Subject has had a prior atrial ablation (except for cavo-tricuspid isthmus (CTI) ablation for AFL)

• Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager

• Subject with exclusion criteria required by local law

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Device:
• Arctic Front™ Cardiac Cryoablation Catheter
Pulmonary vein isolation will be performed with the Arctic Front™ cardiac cryoablation catheter system

Locations

Country	Name	City	State
United States	Alaska Heart Institute	Anchorage	Alaska
United States	Our Lady of the Lake	Baton Rouge	Louisiana
United States	The Lindner Research Center	Cincinnati	Ohio
United States	BayCare Medical Group Cardiology	Clearwater	Florida
United States	Texas Health Research and Education Institute	Dallas	Texas
United States	Heart Rhythm Solutions	Davie	Florida
United States	Henry Ford Heart & Vascular	Detroit	Michigan
United States	Stern Cardiovascular Foundation	Germantown	Tennessee
United States	University of Tennessee Methodist Physicians	Memphis	Tennessee
United States	Southcoast Health System	North Dartmouth	Massachusetts
United States	Cardiology Associates of Fairfield County	Stamford	Connecticut
United States	MedStar Washington Hospital Center	Washington	District of Columbia
United States	Iowa Heart	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Country where clinical trial is conducted

United States, 

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 Atrial Fibrillation (AF) /atrial flutter (AFL) /Atrial Tachycardia (AT) recurrence using the Arctic Front™ cardiac cryoablation catheter System.	36 months
Primary	Freedom from Primary Safety Events	Estimate primary safety Adverse Event (AE) rates for cryoablation using the Arctic Front™ cardiac cryoablation catheter System through 12-months.	12 months