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

nContact Surgical

Status

Terminated

Conditions

Atrial Fibrillation

Treatments

Device: Numeris-AF Tethered Coagulation System with VisiTrax

Study type

Interventional

Funder types

Industry

Identifiers

NCT00950092

VAL-1116(C)

Details and patient eligibility

About

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.

Full description

The purpose of this study is to determine the safety and efficacy of the Numeris-AF Tethered Coagulation System with VisiTrax when used to treat persistent and longstanding persistent Atrial Fibrillation(AF)during concomitant cardiac surgery.

Enrollment

5 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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).