NCT01103674

Brief Summary

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

Trial Health

57
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Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2010

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 13, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 15, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

April 3, 2014

Status Verified

July 1, 2012

Enrollment Period

2 years

First QC Date

April 13, 2010

Last Update Submit

April 2, 2014

Conditions

Paroxysmal Atrial Fibrillation

Keywords

Paroxysmal Atrial FibrillationAFAtrial FibrillationRF ablation

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 Numeris®-AF Guided Coagulation System with VisiTrax® epicardially and the Biosense Webster ThermoCool Catheter in conjunction with the Carto Navigation System endocardially.

Numeris-AF Guided Coagulation System

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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)
  • Symptomatic paroxysmal AF
  • Provided written informed consent
  • Refractory to at least one AAD (class I, II, III or IV)

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
  • Right ventricular outflow tract obstruction
  • History of pericarditis
  • Previous cerebrovascular accident (CVA), excluding fully resolved TIA
  • Patients who have severe chronic obstructive pulmonary disease (COPD)
  • Patients who have an 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Baptist Memorial Hospital

Memphis, Tennessee, 38120, United States

Location

Texas Cardiac Arrhythmia Institute, St. David's Hospital

Austin, Texas, 78705, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Rodney Horton, MD

    Texas Cardiac Arrhythmia Institute, St. David's Medical Center

    PRINCIPAL INVESTIGATOR

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

March 1, 2010

Primary Completion

March 1, 2012

Study Completion

July 1, 2012

Last Updated

April 3, 2014

Record last verified: 2012-07

Locations

US(2)