Atrial Fibrillation Ablation Pilot Study

Atrial Fibrillation Clinical Trial

Official title:

Atrial Fibrillation Ablation Pilot Study- Study Number AFI-20

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00744835
• Other study ID #: AFI-20
• Status: Completed
• Phase: Phase 1
• Start date: August 2006
• Est. completion date: July 2008

Study information

• Verified date: September 2018
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: July 2008
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Ablation procedure and/or cardioversion
Ablation Frontiers Cardiac Ablation System

Locations

Country	Name	City	State
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
Switzerland	Klinic im Park	Zürich
United Kingdom	Papworth Hospital	Cambridge
United Kingdom	St. George's University of London	London
United Kingdom	St. Mary's Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Countries where clinical trial is conducted

Netherlands,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The acute/chronic safety endpoint is recording of all Severe Adverse Events (device and procedure related) followed for six months.		6 months
Secondary	Effectiveness		6 months

External Links

•   Company website