CARTO® 3 System and Real Time Intracardiac Ultrasound (IUAF)

Biosense Webster

Status: Completed

Conditions: Atrial Fibrillation; Paroxysmal AF

Treatments: Device: Catheter Ablation

Study type: Observational

Funder types: Industry

Identifiers

NCT01716663

IUAF

Details and patient eligibility

About

This is a prospective, multicenter, non-randomized observational study of subjects 18 years and older undergoing RF ablation with drug refractory recurrent symptomatic paroxysmal Atrial Fibrillation (AF).

Full description

This study is purposed to measure "real world" acute procedural outcomes (procedural efficiency and acute safety) associated with use of the CARTO® 3 System and real time intracardiac ultrasound in a clinical setting in subjects with drug refractory recurrent symptomatic paroxysmal AF.

Enrollment: 234 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Drug refractory, recurrent symptomatic paroxysmal AF
• Age 18 years or older
• Patients able and willing to provide written informed consent to participate in the study and comply with study requirements

Exclusion criteria

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

Trial design

234 participants in 1 patient group

Experimental: Catheter Ablation

Description:

These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.

Treatment:

Device: Catheter Ablation