Status:
COMPLETED
Atrial Fibrillation Ablation Pilot Study
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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 s...
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 simila...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00744835
Start Date
August 1 2006
End Date
July 1 2008
Last Update
September 19 2018
Active Locations (5)
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1
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
2
Klinic im Park
Zurich, Switzerland
3
Papworth Hospital
Cambridge, United Kingdom
4
St. George's University of London
London, United Kingdom