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Atrial Fibrillation Ablation Pilot Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier:
NCT00744835
First received: August 28, 2008
Last updated: June 4, 2012
Last verified: June 2012
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Atrial Fibrillation Ablation Pilot Study- Study Number AFI-20

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medtronic Atrial Fibrillation Solutions:

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

Secondary Outcome Measures:
  • Effectiveness [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 53
Study Start Date: August 2006
Study Completion Date: July 2008
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Ablation Management
 Procedure: Ablation procedure and/or cardioversion
Ablation Frontiers Cardiac Ablation System

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00744835

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

Additional Information:
Company website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier: NCT00744835     History of Changes
Other Study ID Numbers: AFI-20
Study First Received: August 28, 2008
Last Updated: June 4, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by Medtronic Atrial Fibrillation Solutions:
atrial fibrillation

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

ClinicalTrials.gov processed this record on May 21, 2013