NCT00744835

Atrial Fibrillation Ablation Pilot Study

Atrial Fibrillation Ablation Pilot Study- Study Number AFI-20

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	Ablation procedure and/or cardioversion	Ablation Frontiers Cardiac Ablation System

Timeline

• Start date: 2006-08-01
• Primary completion: 2007-08-01
• Completion: 2008-07-01
• First posted: 2008-09-01
• Last updated: 2018-09-19

Locations

5 sites across 3 countries: Netherlands, Switzerland, United Kingdom