Atrial Fibrillation Ablation Pilot Study

Medtronic

Status and phase

Completed

Phase 1

Conditions

Atrial Fibrillation

Treatments

Procedure: Ablation procedure and/or cardioversion

Study type

Interventional

Funder types

Industry

Identifiers

NCT00744835

AFI-20

Details and patient eligibility

About

This is a prospective, non-randomized, multicenter, multi-country pilot study to evaluate the safety and effectiveness of the Ablation Frontiers Cardiac Ablation System for the ablative treatment of symptomatic permanent atrial fibrillation.

Full description

The study shall be conducted according to ISO 14155. Results of this research study will be used to assess the performance and safety of the System and its components. Data may be combined with similar research at additional sites to create a greater understanding of the endpoints. Up to sixty (60) patients (including "roll-in" or training patients) will be enrolled in a non-randomized study to assess the safety and efficacy of the Ablation Frontiers Cardiac Ablation System. Further studies may be performed to gather additional data regarding the safety and efficacy of the system.

Patients with a history of symptomatic permanent AF, willing and able to sign an informed consent, and meeting all inclusion/exclusion criteria, as identified by the clinical investigator, will be enrolled in the study. Comparative and descriptive statistics will be used to summarize patient outcomes for the specified study endpoints.

Enrollment

53 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

History of symptomatic permanent atrial fibrillation
Age between 18 and 70
Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study

Exclusion criteria

Structural heart disease of clinical significance
Any prior ablation for atrial fibrillation
Prior ablation for arrhythmias other than AF within the past three months
Enrollment in any other ongoing arrhythmia study protocol
Any ventricular tachyarrhythmias currently being treated where the arrhythmia or the management may interfere with this study
Active infection or sepsis
Any history of cerebral vascular disease including stroke or TIAs
Pregnancy or lactation
Left atrial thrombus at the time of ablation
Untreatable allergy to contrast media
Any diagnosis of AF secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiovascular causes
History of blood clotting (bleeding or thrombotic) abnormalities
Known sensitivities to heparin or warfarin
Severe COPD (identified by an FEV1 < 1)
Severe comorbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the patient to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectance, etc.)