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GENESIS Feasibility Study of the BARD Over-the-Wire Mesh Ablation System for the Treatment of Paroxysmal Atrial Fibrillation

NCT01430949 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2013-09-30

No results posted yet for this study

Summary

The Genesis Feasibility Study will collect clinical information on the use of the Bard Over-the-Wire Mesh Ablation System to access and perform electrophysiological mapping, cardiac stimulation and radiofrequency ablation in the region of the pulmonary vein (PV) ostia for the treatment of patients with Paroxysmal Atrial Fibrillation. Patients will be followed up for 12 months to assess the primary safety endpoint of Major Complications (a composite safety endpoint)and effectiveness, defined as Long-Term Success (freedom from recurrent atrial arrhythmia.

Conditions

  • Paroxysmal Atrial Fibrillation

Interventions

PROCEDURE

Catheter Ablation of Paroxysmal Atrial Fibrillation

Catheter ablation for the treatment of paroxysmal atrial fibrillation. A pulmonary vein isolation procedure will be performed using the OTW MAS and radiofrequency ablation.

Sponsors & Collaborators

  • C. R. Bard

    lead INDUSTRY

Principal Investigators

  • David Ciavarella, MD · CR Bard Inc

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • Canada
  • Germany
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01430949 on ClinicalTrials.gov