Ablation of the Pulmonary Veins for Paroxysmal Afib

Study Overview
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Brief Summary
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The purpose of this trial was to investigate and confirm the safety, efficacy, and efficiency of the Ablation Frontiers® Cardiac Ablation System when used in the treatment of paroxysmal atrial fibrillation. (PAF)

Detailed Description
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This trial was a non-randomized, multi-center, prospective study of subjects with symptomatic, paroxysmal atrial fibrillation (PAF). The purpose of this study was to investigate and confirm the safety, efficacy and efficiency of the Medtronic Ablation Frontiers® Cardiac Ablation System when used for the treatment of paroxysmal AF. The trial was conducted over a 2 year period with enrollment occurring between 4 October 2007 and 1 December 2008.

Official Title
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Multi-Array Ablation of the Pulmonary Veins for Paroxysmal Atrial Fibrillation

Conditions
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Paroxysmal Atrial Fibrillation

Intervention / Treatment
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* Procedure: RF Ablation procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of symptomatic paroxysmal atrial fibrillation defined as: Self terminating AF lasting no more than 7 days AF events demostrating spontaneous conversion back to sinus rhythm Documentation of one or more events with PAF tracings by ECG, event recordings, pacemaker strips or monitor rhythm strips within the past year AF symptoms defined as the manisfestation of any of the following: Palpitations, Fatigue, Exertional dyspnea, effort intolerance 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 Prior ablation for arrhythmias other than AF within the past three months Prior left sided AF ablation 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 Untreatable allergy to contrast media Any diagnosis of atrial fibrillation 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 co morbidity 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.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ablated Patients<br>Patients with a history of symptomatic paroxysmal (self-terminating) AF and meeting all inclusion/exclusion criteria, as identified by the clinical investigator, will be enrolled in the study. | Procedure: RF Ablation procedure<br>* Patients with a history of symptomatic paroxysmal (self-terminating) AF and meeting all inclusion/exclusion criteria, as identified by the clinical investigator, will be enrolled in the study.<br>* Other names: Radio Frequency Ablation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Successful Pulmonary Vein Isolation | Acute effectiveness was defined as successful isolation of all pulmonary veins. Pulmonary vein isolation was documented by the absence of pulmonary vein potentials when assessed by electrogram tracings in sinus rhythm using the PVAC catheter. | 6 months | 
| Chronic Effectiveness | The primary endpoint for chronic effectiveness was the evaluation of the proportion of subjects with treatment success computed at the 6 month visit. In order to be classified as a chronic success, all subjects were required to meet the following criteria: Absence of clinically significant AF (greater than 60 seconds) or left atrial tachycardia recorded on a 7-day Holter, absence of symptomatic AF after a 3 month blanking period, off all Class I and III AADs at 6 months. | 6 months | 
| Acute Safety | The Acute Safety Endpoint was defined as the proportion of subjects with Serious Adverse Events (SAEs) that were procedure- and/or device-related within 7 days after the ablation procedure. The relatedness of each event was assessed by the investigator at each site. | 7 days post procedure | 
| Chronic Safety | The Chronic Safety Endpoint was the proportion of subjects with serious procedure- and/or device-related events in the 7 day to 6 month follow-up period post-ablation. The relatedness of each event was assessed by the investigator at each site. | 7 day post procedure to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial Fibrillation Symptom Severity Scores From Baseline to 6 Months | Subjects rated the severity of their AF-related symptoms at baseline and at each follow-up visit for the study. Symptoms that were assessed at each visit included the presence of palpitations, fatigue, shortness of breath, lightheadedness or dizziness, and/or lack of energy upon exertion or exercise. Each symptom was rated on a scale from 1 (no symptoms) to 5 (most severe). Total scores were obtained by adding up the rating for each symptom to obtain a range of results between 5 (asymptomatic) to 25 (severely symptomatic). | 6 Months | 
| The Short Form 36 Question (SF-36) Health Survey Quality of Life Survey at 6 Months Compared to Baseline | The SF-36 is a short-form health survey of 36 questions that yields an 8-scale health profile as well as psychometrically-based physical and mental health summary measures. In order to assess improvement in self-perceived quality of life, subjects were asked to complete SF-36 questionnaires at baseline and at each follow-up visit. The results of the Physical Component and Mental Component scores from the two summary measures that aggregate sub-scales were then compared.The SF-36 subscales range from 0 (lowest) to 100 (highest). The subscales are averaged together for a total score between 0 to 100. A higher score represents a better outcome when compared to a lower score. | 6 months | 
| Measurement of the Cumulative RF Time for Pulmonary Vein(PV)Isolation of All Accessible Pulmonary Veins | Cumulative RF time was calculated by the difference between the start time of catheter ablations and the end time of the ablation | After Procedure | 
| Total Procedure Time | Measurement of total procedure time defined as skin to skin and left atrial dwell time (transseptal puncture to removal of all left atrial catheters) | End of Procedure | 
| Total Fluoroscopy Time | Total time that flouroscopy was used during the ablation procedure. | Post Ablation Procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation