Safety and Efficacy Study of the Combined Ablation Procedure to Treat Paroxysmal Atrial Fibrillation

Paroxysmal Atrial Fibrillation Clinical Trial

— CAP STOPS AF  

Official title:

Feasibility Study For Safety and Efficacy Evaluation Of The Combined Ablation Procedure For The Treatment Of Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01103674
• Other study ID #: VAL-1150
• Status: Terminated
• Phase: N/A
• First received: April 13, 2010
• Last updated: April 2, 2014
• Start date: March 2010
• Est. completion date: July 2012

Study information

• Verified date: July 2012
• Source: nContact Surgical Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

The purpose of this feasibility study is to evaluate the safety and efficacy of the epicardial / endocardial combined procedure for the treatment of drug refractory symptomatic Paroxysmal Atrial Fibrillation (AF) patients, using the nContact Numeris®-AF Guided Coagulation System with VisiTrax® epicardially and the Biosense Webster NaviStar® ThermoCool® Diagnostic/Ablation deflectable Tip Catheter in conjunction with the Carto Navigation System endocardially.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: July 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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)

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

• 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

• 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).

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

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

Locations

Country	Name	City	State
United States	Texas Cardiac Arrhythmia Institute, St. David's Hospital	Austin	Texas
United States	Baptist Memorial Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
nContact Surgical Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	AF free regardless of the Class I and III AADs status	The secondary efficacy data will be an evaluation 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.	12 months	No