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TerminatedNCT01103661CAPstopsLSPAFUpdated Apr 3, 2014

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

An interventional study of Numeris®-AF Guided Coagulation System with VisiTrax® in Atrial Fibrillation, sponsored by nContact Surgical Inc.. Terminated at 4 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-04-03.

Sponsored by nContact Surgical Inc. (part of AtriCure, Inc.) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed description

The purpose of this feasibility study is to evaluate the safety and efficacy of the epicardial / endocardial combined procedure using the nContact Numeris®-AF Guided Coagulation System with VisiTrax® epicardially and the St. Jude Medical Therapy™ Cool Path™ Ablation Catheter endocardially to treat longstanding persistent Atrial Fibrillation (AF) patients.

02

Conditions studied

  • Atrial Fibrillation

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Keywords

  • Longstanding Persistent Atrial Fibrillation
  • AF
  • Chronic AF
  • RF Ablation
  • nContact Surgical
  • Therapy Cool Path Ablation Catheter
  • St. Jude Medical
03

In context

Atrial Fibrillation

3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.

This study's enrollment of 7 is below the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

nContact Surgical Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.

First submitted before nContact Surgical Inc. became part of AtriCure, Inc..

Browse nContact Surgical Inc. studies →All AtriCure, Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • 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
  • Not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Other
    Numeris-AF Guided Coagulation System

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

Interventions

  • DeviceNumeris®-AF Guided Coagulation System with VisiTrax®

    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.

06

What researchers measure

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.

    Time frame: 12 months

Secondary outcomes

  1. AF free regardless of the Class I and III AADs status

    The secondary efficacy data will be an assessment of the number of subjects free from AF regardless of their Class I and III AADs status from 3 months through 12 months post procedure.

    Time frame: 12 months

07

Study locations

4 sites
  • The Care Group, St Vincent Hospital
    Indianapolis, Indiana 46250, United States
  • Baptist Memorial Hospital
    Memphis, Tennessee 38120, United States
  • Texas Cardiac Arrhythmia Institute, St. David's Hospital
    Austin, Texas 78705, United States
  • Cardiothoracic Surgical Associates, CJW Medical Center
    Richmond, Virginia 23225, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2010, a primary completion of Oct 2012 and a completion of Apr 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 13, 2010
First posted
Apr 15, 2010
Start
Apr 2010
Primary completionActual
Oct 2012
CompletionActual
Apr 2013
Last update
Apr 3, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 3, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01103661
Lead sponsor
nContact Surgical Inc.
Responsible party
Sponsor
First posted
Apr 15, 2010
Start date
Apr 2010
Primary completion
Oct 2012
Completion
Apr 2013
Last update
Apr 3, 2014

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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