Safety and Efficacy Study of the Combined Ablation Procedure to Treat Paroxysmal Atrial Fibrillation (NCT01103674) | Clinical Trial Compass
TerminatedNot Applicable
Safety and Efficacy Study of the Combined Ablation Procedure to Treat Paroxysmal Atrial Fibrillation
Stopped: enrollment challenges, only one patient enrolled
United States1 participantsStarted 2010-03
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
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
* 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).
What they're measuring
1
AF free off all Class I and III Anti Arrhythmic Drugs (AADs).