NAVISTAR® THERMOCOOL® SF Catheter: Observational Study (SFAF)

Biosense Webster

Status: Completed

Conditions: Atrial Fibrillation; Paroxysmal Arrhythmia

Treatments: Device: Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter)

Study type: Observational

Funder types: Industry

Identifiers

NCT01585961

ThermoCool SF Phase IV

Details and patient eligibility

About

This is a prospective, interventional, observational, unblinded, single-arm, multicenter registry of younger and older subjects with drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation.

Full description

This study is to measure the "real-world" acute procedural outcomes (procedural efficiency, acute safety, and effectiveness at one year) associated with use of the NAVISTAR® THERMOCOOL® SF Catheter in a clinical setting in subjects with drug refractory, recurrent symptomatic paroxysmal atrial fibrillation.

Enrollment: 511 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation
• Age 18 years or older
• Patients must be able and willing to provide written informed consent to participate in the study

Exclusion criteria

• Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
• Previous ablation for atrial fibrillation
• Episodes of atrial fibrillation that last longer than 30 days and are terminated via cardioversion
• Uncontrolled heart failure, or NYHA Class III or IV heart failure
• Documented intra-atrial thrombus or other abnormality on pre-ablation echocardiogram
• Contraindication to anticoagulation
• Stroke, cardiac surgery, unstable angina, myocardial infarction or percutaneous coronary intervention within the past 3 months
• Awaiting cardiac transplantation
• Heart disease in which corrective surgery is anticipated within 6 months
• Enrollment in investigational drug, biologic or device study
• Subjects unwilling to comply with protocol or follow-up requirements
• Patients who are pregnant

Trial design

511 participants in 1 patient group

Catheter Ablation

Description:

These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and have provided written informed consent to participate in the study, including consent to undergo catheter ablation with the study device.

Treatment:

Device: Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter)