Safety and Efficacy Study of the Combined Ablation Procedure to Treat Paroxysmal Atrial Fibrillation
Stopped early · Not applicable
Conditions studied: Paroxysmal Atrial Fibrillation
In brief
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.
Key facts
- Study ID
- NCT01103674
- Run by
- nContact Surgical Inc.
- People needed
- 1
- Starts
- 2010-03-01
- Expected to finish
- 2012-07-01
- 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)
- Symptomatic paroxysmal AF
- Provided written informed consent
- Refractory to at least one AAD (class I, II, III or IV)
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
- 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).
Where it is running
- Baptist Memorial Hospital — Memphis, Tennessee, United States
- Texas Cardiac Arrhythmia Institute, St. David's Hospital — Austin, Texas, United States
Full record on ClinicalTrials.gov
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