Ablation of the Pulmonary Veins for Paroxysmal Afib

NCT ID: NCT00744874

Last Updated: 2018-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2011-07-31

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.

Conditions

Paroxysmal Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ablated Patients

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.

Group Type: EXPERIMENTAL

RF Ablation procedure

Intervention Type: PROCEDURE

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.

Interventions

RF Ablation procedure

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.

Intervention Type: PROCEDURE

Other Intervention Names

Radio Frequency Ablation

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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rigshospitalet

Copenhagen, , Denmark

Hjertecenter Varde

Varde, , Denmark

Zentralklinik

Bad Berka, , Germany

St. Antonius Ziekenhuis

Nieuwegein, , Netherlands

Klinik im Park

Zurich, , Switzerland

Countries

Denmark; Germany; Netherlands; Switzerland

Related Links

http://www.ablationfrontiers.com

Company website

Other Identifiers

AFI-40

Identifier Type: -

Identifier Source: org_study_id