200 Participants Needed

Treatment for Atrial Fibrillation

Recruiting at 13 trial locations
MS
TP
RR
JD
Overseen ByJennifer Diouf
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Medtronic Cardiac Ablation Solutions
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of the Arctic Front™ cardiac cryoablation catheter system in treating paroxysmal atrial fibrillation (AF), a type of irregular heartbeat. The primary goal is to determine if this treatment can alleviate noticeable symptoms in individuals with AF. Ideal participants are those diagnosed with symptomatic paroxysmal AF who plan to undergo a procedure to isolate the pulmonary veins using this system. As a Phase 3 trial, it represents the final step before FDA approval, providing participants an opportunity to contribute to the potential availability of a new treatment option.

Why are researchers excited about this trial?

Most treatments for atrial fibrillation (AF) involve medications like beta-blockers or anti-arrhythmic drugs to manage heart rhythm. However, researchers are excited about the STOP AF First treatment because it utilizes a technique called cryoablation. Unlike traditional drug therapies, cryoablation targets the source of AF by freezing and destroying the problematic heart tissue that causes irregular rhythms. This approach can potentially offer long-term relief and reduce the need for ongoing medication. Additionally, cryoablation is minimally invasive, which can lead to quicker recovery times compared to other more invasive procedures.

Who Is on the Research Team?

KT

Khaldoun Tarakji, MD

Principal Investigator

Medtronic CAS Chief Medical Officer

Are You a Good Fit for This Trial?

Inclusion Criteria

Subject has been diagnosed with symptomatic paroxysmal AF
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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are treated with the Arctic Front™ Cardiac Cryoablation Catheter System as an initial rhythm control strategy

Varies

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

What Are the Treatments Tested in This Trial?

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medtronic Cardiac Ablation Solutions

Lead Sponsor

Trials
29
Recruited
16,000+

Medtronic Cardiac Rhythm and Heart Failure

Lead Sponsor

Trials
206
Recruited
137,000+
Geoff Martha profile image

Geoff Martha

Medtronic Cardiac Rhythm and Heart Failure

Chief Executive Officer since 2020

MBA from University of Minnesota

Dr. Kweli Thompson profile image

Dr. Kweli Thompson

Medtronic Cardiac Rhythm and Heart Failure

Chief Medical Officer since 2022

MD from Harvard Medical School