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

Paroxysmal Atrial Fibrillation Clinical Trial

— GENESIS  

Official title:

A Single-Arm Multi-Center Trial of Radiofrequency Ablation for the Treatment of Paroxysmal Atrial Fibrillation Using the Bard Over-the-Wire Ablation System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01430949
• Other study ID #: BEP-4409-2010
• Status: Completed
• Phase: Phase 2
• First received: September 7, 2011
• Last updated: September 27, 2013
• Start date: November 2011
• Est. completion date: August 2013

Study information

• Verified date: September 2013
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyCanada: Health CanadaGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Description:

Atrial fibrillation (AF) is the most common sustained arrhythmia seen by the physician. Its prevalence in the population increases with age, and it is estimated to affect over 4% of the population above the age of 60. Common approaches to AF management includes the use of anti-arrhythmic drugs to control the arrhythmia.

An alternative to treatment of AF using drug therapy is ablation of cardiac tissue, with the goal of disrupting the aberrant electrical pathways that cause AF through the creation of ablation lesions within the left atrium. There are several different approaches to creating lesions to treat AF, although both substrate derived and focal AF mechanisms share a common ablation therapy protocol in which the PVs are isolated by a series of ablation lines placed endocardially, either around the PV ostia or more proximally from the PV ostia at the atrial carinae.

The Over-the-Wire Mesh Ablation System (OTW MAS) catheter is a combined mapping and ablation catheter designed to create lesions at the PV ostium. The Genesis Feasibility Study is designed to collect clinical information on the use of the OTW MAS 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 (PAF).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

• 18 years or older.

Exclusion Criteria:

• 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.

• Congestive heart failure (NYHA classification III or IV).

• Renal dialysis or creatinine > 2.0 mg/dl.

• Contraindication to anti-coagulation therapy (e.g., warfarin, heparin).

• Contraindication to transseptal procedure.

• Any cerebral ischemic event, including TIA in the 6 months prior to screening.

• Any known uncontrolled bleeding or thrombotic disorder.

• Women who are known to be pregnant or nursing.

• Uncontrolled hyperthyroidism.

• Patients currently enrolled in any other study during the 30 days prior to screening.

• Any other significant uncontrolled or unstable medical condition (e.g., active systemic infection).

• A life expectancy of less than one year.

• Currently documented intracardiac thrombus.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

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.

Locations

Country	Name	City	State
Canada	University Hospital	London	Ontario
Canada	Southlake Regional Health Centre	Newmarket	Ontario
Germany	Herz-und Gefässzentrum Bad Bevensen	Bad Bevensen
Germany	Deutsches Herzzentrum Berlin (DHZB)	Berlin
Germany	Herzzentrum Munchen	Munich
United Kingdom	The Heart Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
C. R. Bard

Countries where clinical trial is conducted

Canada,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Safety	Incidence of device-related early-onset primary serious adverse events or adverse device effects. Includes serious adverse events occurring within 7 days of the index procedure and diagnosed at any time during the follow-up period.	12 months	Yes