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STOP AF First: Cryoballoon Catheter Ablation in an Antiarrhythmic Drug Naive Paroxysmal Atrial Fibrillation

NCT03118518 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2025-02-13

Study results available
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Summary

To provide data demonstrating the safety and effectiveness of the Arctic Front Advance™ Cardiac CryoAblation Catheter for the treatment of recurrent symptomatic paroxysmal atrial fibrillation, without the requirement that the subjects be drug refractory.

Conditions

Interventions

DEVICE

Cryoablation

Pulmonary vein isolation via ablation with cryoballoon catheter

DRUG

Antiarrhythmic drug

Antiarrhythmic drug initiation

Sponsors & Collaborators

  • Medtronic Cardiac Ablation Solutions

    lead INDUSTRY

Principal Investigators

  • Oussama Wazni, MD · The Cleveland Clinic

  • Gopi Dandamudi, MD · Franciscan Heart & Vascular Associates at St. Joseph

  • Steve Nissen, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-23
Primary Completion
2020-06-25
Completion
2020-06-25
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03118518 on ClinicalTrials.gov