Ablation of the Pulmonary Veins for Paroxysmal Afib (MAP-PAF)

Medtronic

Status and phase: Completed; Phase 4

Conditions: Paroxysmal Atrial Fibrillation

Treatments: Procedure: RF Ablation procedure

Study type: Interventional

Funder types: Industry

Identifiers

NCT00744874

AFI-40

Details and patient eligibility

About

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)

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

Ablated Patients

Experimental group

Description:

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.

Treatment:

Procedure: RF Ablation procedure