Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
53 participants
INTERVENTIONAL
2006-08-31
2008-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Ablation Management
Ablation procedure and/or cardioversion
Ablation Frontiers Cardiac Ablation System
Interventions
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Ablation procedure and/or cardioversion
Ablation Frontiers Cardiac Ablation System
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.)
18 Years
70 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Locations
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St. Antonius Ziekenhuis
Nieuwegein, , Netherlands
Klinic im Park
Zurich, , Switzerland
Papworth Hospital
Cambridge, , United Kingdom
St. George's University of London
London, , United Kingdom
St. Mary's Hospital
London, , United Kingdom
Countries
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Related Links
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Company website
Other Identifiers
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AFI-20
Identifier Type: -
Identifier Source: org_study_id
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