nContactSurgical Numeris-AF Tethered Coagulation System for Treatment of Persistent & LSP AF

Stopped early · Not applicable

Conditions studied: Atrial Fibrillation

In brief

This is a multi center, non-randomized, prospective, open label, clinical trial evaluating the safety and efficacy of the nContact Surgical Numeris-AF Tethered Coagulation System when used to treat patients with persistent and longstanding persistent AF during concomitant cardiac surgery.

Key facts

Study ID

NCT00950092

Run by

nContact Surgical Inc.

People needed

5

Starts

2009-10-01

Expected to finish

2013-10-01

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 =< 6.0 cm
• Documented persistent or longstanding persistent AF
• History of AF =< 10 years
• Scheduled for a concomitant cardiac procedure
• Coronary bypass surgery (CABG)
• Mitral valve repair/replacement
• Aortic valve replacement
• ASD repair
• Tricuspid valve repair/replacement
• Myxoma
• Any combination of the above procedures
• Provided written informed consent

You may not qualify if…

• Left atrial size > 6.0 cm (pre-op TTE - parasternal 4 chamber view)
• History of AF > 10 years
• Left ventricular ejection fraction < 30%
• Pregnant or planning to become pregnant during study
• Co-morbid medical conditions that limit one year life expectancy
• History of coagulopathy
• Patients who are contraindicated for anticoagulants(heparin, warfarin etc.)
• Previous cardiac surgery
• History of pericarditis
• Previous cerebrovascular accident (CVA)
• Patients who have active infection or sepsis
• Patients who have uncorrected reversible cause(s) of AF such as hyperthyroidism and electrolyte imbalance
• Patients who are being treated for ventricular arrhythmias
• Patients who have had a previous catheter ablation for AF (does not include ablation for Aflutter)
• 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

• Venice Regional Medical Center — Venice, Florida, United States
• Baptist Memorial Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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