Safety and Efficacy Study of The Combined Ablation Procedure To Treat Longstanding Persistent Atrial Fibrillation

NCT01103661 | Terminated DMC

• 1 other identifier: VAL-1140
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 4

Brief Summary

This is a multi-center, prospective open label, feasibility study evaluating the safety and efficacy of the combined ablation procedure for the treatment of longstanding persistent atrial fibrillation.

Conditions

Atrial Fibrillation

Keywords

Longstanding Persistent Atrial Fibrillation; AF; Chronic AF; RF Ablation; nContact Surgical; Therapy Cool Path Ablation Catheter; St. Jude Medical

Outcome Measures

Primary Outcomes (1)

• AF free, off all Class I and III Anti Arrhythmic Drugs (AADs)

  The primary efficacy data will be an evaluation of the number of subjects free from AF and free of all Class I and III Anti Arrhythmic Drugs (AADs) from 3 months through 12 months post procedure.

  12 months

Secondary Outcomes (1)

• AF free regardless of the Class I and III AADs status

  12 months

Study Arms (1)

Numeris-AF Guided Coagulation System

OTHER

Device: Numeris®-AF Guided Coagulation System with VisiTrax®

Interventions

Numeris®-AF Guided Coagulation System with VisiTrax® DEVICE

Combined epicardial / endocardial procedure using the nContact Numeris®-AF Guided Coagulation System with VisiTrax® epicardially and the St. Jude Medical Therapy™ Cool Path™ Ablation Catheter endocardially.

Numeris-AF Guided Coagulation System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years; \< 80 years
• Left atrium less than or equal to 6.5 cm (TTE)
• History of AF for less than or equal to 10 years
• Provided written informed consent
• Symptomatic longstanding persistent Atrial Fibrillation (AF).

You may not qualify if:

• Patients requiring concomitant surgery
• Left ventricular ejection fraction \< 30%
• Pregnant or planning to become pregnant during study
• Co-morbid medical conditions that limit one year life expectancy
• Measured left ventricular wall thickness \> 1.5 cm
• History of coagulopathy
• Previous cardiac surgery
• History of pericarditis
• Previous cerebrovascular accident (CVA), excluding fully resolved TIA
• Patients who have active infection or sepsis
• Patients who have uncorrected reversible cause(s) of AF
• Patients who are contraindicated for anticoagulants
• Patients who are being treated for arrhythmias other than AF
• Patients who have had any previous AF or left atrial catheter ablation
• Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment

Sponsors & Collaborators

• nContact Surgical Inc.: lead

Study Sites (4)

The Care Group, St Vincent Hospital

Indianapolis, Indiana, 46250, United States

Location

Baptist Memorial Hospital

Memphis, Tennessee, 38120, United States

Location

Texas Cardiac Arrhythmia Institute, St. David's Hospital

Austin, Texas, 78705, United States

Location

Cardiothoracic Surgical Associates, CJW Medical Center

Richmond, Virginia, 23225, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2010
• First Posted: April 15, 2010
• Study Start: April 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: April 1, 2013
• Last Updated: April 3, 2014

Record last verified: 2013-04

Locations

US (4)