Study of HD Mesh Ablation System for Treatment of Paroxysmal Atrial Fibrillation

Paroxysmal Atrial Fibrillation Clinical Trial

— MAGELLAN  

Official title:

A Randomized Controlled Trial of Radiofrequency Ablation for the Treatment of Paroxysmal Atrial Fibrillation Using the Bard High Density Mesh Ablation System (MAGELLAN)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00741611
• Other study ID #: BEP-4408-2007
• Secondary ID: IDE # G070179
• Status: Terminated
• Phase: Phase 3
• First received: August 25, 2008
• Last updated: September 26, 2012
• Start date: July 2008
• Est. completion date: November 2009

Study information

• Verified date: September 2012
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a randomized controlled study of the Bard High Density Mesh Ablation System for treatment of paroxysmal atrial fibrillation. This study will determine if the HD Mesh Ablation System is as safe as and more effective than anti-arrhythmic drugs.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients with symptomatic paroxysmal atrial fibrillation who have failed at least one class I or III anti-arrhythmic drug

• Other inclusion criteria

Exclusion Criteria:

• Previous surgical or catheter ablation to treat AF

• Permanent AF

• Uncontrolled or unstable medical conditions

• Other exclusion criteria

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Device:
• HD Mesh Ablation System
Ablation using the HD Mesh Ablation System

Drug:
• Anti-arrhythmic drugs
5 anti-arrhythmic drugs administered at the labeled dosage for atrial fibrillation

Locations

Country	Name	City	State
United States	Lehigh Valley Heart Specialists	Allentown	Pennsylvania
United States	Piedmont Hospital Research Institute	Atlanta	Georgia
United States	Aurora Denver Cardiology Associates	Aurora	Colorado
United States	Northeast Cardiology Associates	Bangor	Maine
United States	Caritas St. Elizabeth's Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Florida	Gainesville	Florida
United States	Mayo Clinic	Jacksonville	Florida
United States	Florida Heart Group	Orlando	Florida
United States	Rhode Island Hospital	Providence	Rhode Island
United States	University of California, San Diego Medical Center	San Diego	California
United States	St. John's Medical Research Institute	Springfield	Missouri
United States	Bay Heart Group	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
C. R. Bard

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Major Complications	A Major Complication was defined as any adverse event that met the following criteria: 1) event was a Serious Adverse Event; 2) event was related to study device (mesh/mesh toolkit) or study procedure and 3)event was a) a cardiovascular adverse event occurring within 7 days of the procedure and/or b) a direct ablation effect adverse event occurring within 12 months of the study procedure.	12 months	Yes
Primary	Number of Participants With Serious Atrial Fibrillation Events	Due to the early study termination and the small number of randomized patients (seven), this primary endpoint analysis (comparison of the rate of events in the mesh group to the rate in the drug group) could not be performed. Counts of events occurring in the 36 treated patients are reported by study group instead.	12 months	Yes
Primary	Number of Participants With Freedom From Symptomatic Atrial Fibrillation	Due to the early termination and the enrollment of only seven randomized patients, the endpoint was not evaluable.	12 months	No
Secondary	Number of Participants With the Occurrence of Pulmonary Vein Stenosis in Mesh Treated Patients.	Defined as a greater than or equal to 70% diameter reduction in a pulmonary vein compared with the baseline measurement as assessed by an independent core imaging laboratory.	12 months	Yes
Secondary	Number of Participants With Acute Procedural Success in Mesh Treated Patients.	Acute procedural success was defined as the ability to isolate 3 of 4 pulmonary veins with the mesh ablation system alone without the need for further ablation with a distal tip catheter	During the mesh ablation procedure	No