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

Primary Purpose

Atrial Fibrillation

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Numeris®-AF Guided Coagulation System with VisiTrax®
Sponsored by
nContact Surgical Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Longstanding Persistent Atrial Fibrillation, AF, Chronic AF, RF Ablation, nContact Surgical, Therapy Cool Path Ablation Catheter, St. Jude Medical

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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).

Sites / Locations

  • The Care Group, St Vincent Hospital
  • Baptist Memorial Hospital
  • Texas Cardiac Arrhythmia Institute, St. David's Hospital
  • Cardiothoracic Surgical Associates, CJW Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Numeris-AF Guided Coagulation System

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 13, 2010
Last Updated
April 2, 2014
Sponsor
nContact Surgical Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01103661
Brief Title
Safety and Efficacy Study of The Combined Ablation Procedure To Treat Longstanding Persistent Atrial Fibrillation
Acronym
CAPstopsLSPAF
Official Title
Feasibility Study For Safety and Efficacy Evaluation Of The Combined Ablation Procedure For The Treatment Of LongStanding Persistent Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Terminated
Study Start Date
April 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
nContact Surgical Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Longstanding Persistent Atrial Fibrillation, AF, Chronic AF, RF Ablation, nContact Surgical, Therapy Cool Path Ablation Catheter, St. Jude Medical

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Numeris-AF Guided Coagulation System
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Numeris®-AF Guided Coagulation System with VisiTrax®
Intervention Description
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.
Primary Outcome Measure Information:
Title
AF free, off all Class I and III Anti Arrhythmic Drugs (AADs)
Description
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 Outcome Measure Information:
Title
AF free regardless of the Class I and III AADs status
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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).
Facility Information:
Facility Name
The Care Group, St Vincent Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Baptist Memorial Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Texas Cardiac Arrhythmia Institute, St. David's Hospital
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Cardiothoracic Surgical Associates, CJW Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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