Atrial Fibrillation Ablation Pilot Study

NCT00744835 | Completed Phase 1 DMC

• 1 other identifier: AFI-20
• Study Type: interventional
• Target: 53
• Locations: 3 countries
• Sites: 5

Brief 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.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• The acute/chronic safety endpoint is recording of all Severe Adverse Events (device and procedure related) followed for six months.

  6 months

Secondary Outcomes (1)

• Effectiveness

  6 months

Study Arms (1)

1

EXPERIMENTAL

Ablation Management

Procedure: Ablation procedure and/or cardioversion

Interventions

Ablation procedure and/or cardioversion PROCEDURE

Ablation Frontiers Cardiac Ablation System

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (5)

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

Klinic im Park

Zurich, Switzerland

Location

Papworth Hospital

Cambridge, United Kingdom

Location

St. George's University of London

London, United Kingdom

Location

St. Mary's Hospital

London, United Kingdom

Location

Related Links

• Company website

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2008
• First Posted: September 1, 2008
• Study Start: August 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: July 1, 2008
• Last Updated: September 19, 2018

Record last verified: 2018-09

Locations

CH (1); NL (1); GB (3)