Atrial Fibrillation Clinical Trial
— CryoLAEFOfficial title:
Effect of Cryoballoon Versus Radiofrequency Ablation for Pulmonary Vein Isolation on Left Atrial Function in Patients With Non-valvular Paroxysmal Atrial Fibrillation
120 consecutive patients with paroxysmal AF, slated for PV isolation, will be randomly assigned to RF or cryoballoon ablation (in a 1:2 allocation scheme). Real-time 3D echocardiography (RT3DE) will be performed before the ablation procedure and 1 month post-ablation. The RT3DE datasets will be stored digitally and quantitative analyses will be performed off-line at a core echo laboratory. Quantification of left atrial volumes will be performed and left atrial functional quantification will be performed by calculating the following indices: Left atrial ejection fraction, Active atrial emptying fraction, Passive atrial emptying fraction, Atrial expansion index. All patients will be hospitalized for 48 hours post-ablation. Blood samples will be obtained at 12-hour intervals to measure troponin T with a high-sensitivity assay, as well as other biochemical parameters.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | September 2017 |
Est. primary completion date | May 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 80 Years |
Eligibility |
Inclusion Criteria: - At least two AF episodes within the last 12 months (either self-terminating within 7 days or cardioverted, medically or electrically, in less than 48 hours), - AF episodes should have been symptomatic on at least 2 occasions within the last 12 months, - Failure of at least one class I or III antiarrhythmic to prevent AF paroxysms, - Age 40-80 years old. Exclusion Criteria: - Previous left atrial ablation procedure, - Left atrial diameter >50 mm on TTE (parasternal long axis view), - Known primary electrical heart disease (e.g. Brugada syndrome), - Presence of atrial thrombus, - Prosthetic valve at any position, - Moderate/severe mitral stenosis, - Severe mitral regurgitation, - Active infectious disease or malignancy, - Moderate or severe hepatic impairment (Child-Pugh class B or C), - Severe renal failure (estimated glomerular filtration rate <20 ml/min/1.73 m2), - Participation in a different research protocol (current or within 1 year), - Inability or unwillingness to adhere to standard treatment or to provide consent. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Greece | 2nd Dept. of Cardiology, Univ of Athens Med Sch | Athens | |
Greece | Department of Cardiology, Athens General Hospital "G. Gennimatas" | Athens |
Lead Sponsor | Collaborator |
---|---|
G.Gennimatas General Hospital | Attikon Hospital |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in left atrial ejection fraction | 30 days | No | |
Secondary | Maximal post-procedural troponin T | 48 h | Yes |
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