Ablation of the Pulmonary Veins for Paroxysmal Afib

Medtronic Cardiac Rhythm and Heart Failure55 enrolled

Overview

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)

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Paroxysmal Atrial Fibrillation

Interventions

RF Ablation procedurePROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.)

Locations (5)

Rigshospitalet

Copenhagen, Denmark

Hjertecenter Varde

Varde, Denmark

Zentralklinik

Bad Berka, Germany

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Klinik im Park

Zurich, Switzerland

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 7 day post procedure to 6 months

Secondary Outcomes

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).

Data from ClinicalTrials.gov

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