Atrial Fibrillation Ablation Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00744835
Recruitment Status : Completed
First Posted : September 1, 2008
Last Update Posted : June 5, 2012
Information provided by (Responsible Party):
Medtronic Atrial Fibrillation Solutions

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: Ablation procedure and/or cardioversion Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Atrial Fibrillation Ablation Pilot Study- Study Number AFI-20
Study Start Date : August 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Ablation Management
Procedure: Ablation procedure and/or cardioversion
Ablation Frontiers Cardiac Ablation System

Primary Outcome Measures :
  1. The acute/chronic safety endpoint is recording of all Severe Adverse Events (device and procedure related) followed for six months. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Effectiveness [ Time Frame: 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00744835

St. Antonius Ziekenhuis
Nieuwegein, Netherlands
Klinic im Park
Zürich, Switzerland
United Kingdom
Papworth Hospital
Cambridge, United Kingdom
St. George's University of London
London, United Kingdom
St. Mary's Hospital
London, United Kingdom
Sponsors and Collaborators
Medtronic Atrial Fibrillation Solutions

Additional Information:
Responsible Party: Medtronic Atrial Fibrillation Solutions Identifier: NCT00744835     History of Changes
Other Study ID Numbers: AFI-20
First Posted: September 1, 2008    Key Record Dates
Last Update Posted: June 5, 2012
Last Verified: June 2012

Keywords provided by Medtronic Atrial Fibrillation Solutions:
atrial fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes