Clinical Evaluation of Therapy™ Cool Flex Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation (FACT-AF)

Abbott

Status and phase

Completed

Phase 2

Conditions

Paroxysmal Atrial Fibrillation

Treatments

Device: Therapy™ Cool Flex Ablation Catheter

Study type

Interventional

Funder types

Industry

Identifiers

NCT01185613

AF-09-024-EU-AB

Details and patient eligibility

About

The purpose of this study is to observe the performance of Therapy™ Cool Flex™ catheter by documenting the procedural parameters, major complications and recurrence of AF after ablation using Cool Flex ablation catheter for the treatment of paroxysmal atrial fibrillation.

This study is an observational clinical study which is not based on any specific endpoints.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

A signed written Informed Consent form
18 years of age or older
Agrees to comply with follow-up visits and evaluation
Candidate for catheter ablation for the treatment of paroxysmal atrial fibrillation as per the hospital standard of care.

Exclusion criteria

Persistent or Long standing AF
CABG procedure within the last 180 days (six months).
Documented left atrial thrombus on imaging [e.g. Transesophageal echocardiogram (TEE)].
History of blood clotting or bleeding abnormalities.
Contraindication to anticoagulation (i.e. heparin or warfarin).
Enrollment in another investigational study evaluating device or drug that might impact the results of this study.
Women who are pregnant (by history of menstrual period or pregnancy test if the history is considered unreliable).
Acute illness or active systemic infection or sepsis.
Life expectancy less than 12 months.
Uncontrolled heart failure or NYHA class IV heart failure.
Myocardial Infarction within 8 weeks of enrollment or unstable angina