Clinical trial NCT00744874: Ablation of the Pulmonary Veins for Paroxysmal Afib
Official title: Multi-Array Ablation of the Pulmonary Veins for Paroxysmal Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Paroxysmal Atrial Fibrillation
Keywords: atrial fibrillation
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2008-09-01
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Number of Participants With Successful Pulmonary Vein Isolation
timeFrame: 6 months
measure: Chronic Effectiveness
timeFrame: 6 months
measure: Acute Safety
timeFrame: 7 days post procedure
measure: Chronic Safety
timeFrame: 7 day post procedure to 6 months
Secondary outcomes:
measure: Atrial Fibrillation Symptom Severity Scores From Baseline to 6 Months
timeFrame: 6 Months
measure: The Short Form 36 Question (SF-36) Health Survey Quality of Life Survey at 6 Months Compared to Baseline
timeFrame: 6 months
measure: Measurement of the Cumulative RF Time for Pulmonary Vein(PV)Isolation of All Accessible Pulmonary Veins
timeFrame: After Procedure
measure: Total Procedure Time
timeFrame: End of Procedure
measure: Total Fluoroscopy Time
timeFrame: Post Ablation Procedure
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Varde
country: Denmark
facility: Hjertecenter Varde
city: Bad Berka
country: Germany
facility: Zentralklinik
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Zurich
country: Switzerland
facility: Klinik im Park
Study officials:
References: