NCT01430949

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2011

Geographic Reach
3 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

September 30, 2013

Status Verified

September 1, 2013

Enrollment Period

1.8 years

First QC Date

September 7, 2011

Last Update Submit

September 27, 2013

Conditions

Paroxysmal Atrial Fibrillation

Keywords

Paroxysmal Atrial FibrillationCatheter AblationPulmonary Vein IsolationRadio Frequency Ablation

Outcome Measures

Primary Outcomes (1)

  • Efficacy

    Freedom from recurrence of symptomatic atrial fibrillation, atrial tachycardia or atrial flutter. Includes both acute success (successful electrical isolation of all pulmonary veins) and chronic success. Re-treatment for AF with ablation during the 3 month blanking period will not constitute a treatment failure.

    12 months

Secondary Outcomes (1)

  • Safety

    12 months

Study Arms (1)

Over-the-Wire Mesh Ablation System

EXPERIMENTAL
Procedure: Catheter Ablation of Paroxysmal Atrial Fibrillation

Interventions

Catheter Ablation of Paroxysmal Atrial FibrillationPROCEDURE

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

Also known as: GENESIS, BEP-4409, Bard Over-the-Wire Mesh Ablation System, OTW MAS, Paroxysmal Atrial Fibrillation, PAF, Feasibility
Over-the-Wire Mesh Ablation System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic PAF refractory to at least one Class I-IV antiarrhythmic drug.
  • Minimum one documented PAF episode \>30 sec duration within prior 12 months.
  • Minimum three PAF episodes during prior 12 months.
  • years or older.

You may not qualify if:

  • AF due to reversible causes.
  • More than 2 cardioversions during the 6 months
  • Previous surgical or catheter based ablation of the LA to treat AF.
  • Permanent or persistent AF.
  • Requirement for ablation lesions other than those defined in protocol
  • LA \> 50 mm in major dimension(measured by TTE).
  • Any single PV \> 25 mm in major diameter and/or presence of common os not suitable for ablation
  • Ejection fraction \<35%.
  • Patent foramen ovale (PFO)or atrial septal defect (ASD)
  • Cardiac myopathy (e.g., HOCM, cardiac sarcoidosis).
  • Myocardial infarction in previous 2 months screening.
  • Currently unstable angina.
  • Any cardiac surgery in previous 3 months prior to screening.
  • Implantable device capable of recording cardiac rhythm, (e.g ICD, pacemaker or implantable loop recorder.
  • Clinically significant valvular heart disease or a replacement heart valve.
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University Hospital

London, Ontario, N6A 5A5, Canada

Location

Southlake Regional Health Centre

Newmarket, Ontario, L3Y8C3, Canada

Location

Herz-und Gefässzentrum Bad Bevensen

Bad Bevensen, 29549, Germany

Location

Deutsches Herzzentrum Berlin (DHZB)

Berlin, 13353, Germany

Location

Herzzentrum Mūnchen

Munich, 80636, Germany

Location

The Heart Hospital

London, W1G 8HP, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Feasibility Studies

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesEvaluation Studies as TopicHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • David Ciavarella, MD

    CR Bard Inc

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2011

First Posted

September 9, 2011

Study Start

November 1, 2011

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

September 30, 2013

Record last verified: 2013-09

Locations

GB(1)CA(2)DE(3)