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

Atrial Fibrillation Clinical Trial

— CAPstopsLSPAF  

Official title:

Feasibility Study For Safety and Efficacy Evaluation Of The Combined Ablation Procedure For The Treatment Of LongStanding Persistent Atrial Fibrillation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01103661
• Other study ID #: VAL-1140
• Status: Terminated
• Phase: N/A
• First received: April 13, 2010
• Last updated: April 2, 2014
• Start date: April 2010
• Est. completion date: April 2013

Study information

• Verified date: April 2013
• 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 study evaluating the safety and efficacy of the combined ablation procedure for the treatment of longstanding persistent atrial fibrillation.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: April 2013
• Est. primary completion date: October 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)

• 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).

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Numeris®-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.

Locations

Country	Name	City	State
United States	Texas Cardiac Arrhythmia Institute, St. David's Hospital	Austin	Texas
United States	The Care Group, St Vincent Hospital	Indianapolis	Indiana
United States	Baptist Memorial Hospital	Memphis	Tennessee
United States	Cardiothoracic Surgical Associates, CJW Medical Center	Richmond	Virginia

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 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.	12 months	No