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

Stopped early · Not applicable

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT01103661

Run by

nContact Surgical Inc.

People needed

7

Starts

2010-04-01

Expected to finish

2013-04-01

Last updated by the study team

2014-04-03

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

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
• 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).

Where it is running

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

Full record on ClinicalTrials.gov

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