Atrial Fibrillation
Conditions
Keywords
Pulmonary veins ablation, Paroxysmal atrial fibrillation
Brief summary
Atrial fibrillation is the most common serious abnormal heart rhythm affecting about 2% to 3% of the population, being associated with a 1.5- to 1.9-fold higher risk of death. Patients with paroxysmal AF in whom antiarrhythmic drug therapy does not elicit a response are potential candidates for RF ablation of AF. The success rate of RF ablation in the treatment of AF varies depending on the type and duration of AF (ie, paroxysmal vs persistent), structural remodeling of the heart, co-morbidities and the technique of the cardiac electrophysiologist, but it usually ranges from 60-80% over 1-2 years of follow-up. To study and predict the successful outcome of RF ablation is of great clinical importance. Moreover, the detection of predictive factors for successful outcome may alter the therapeutic strategy determining a subgroup of patients in the need of more invasive management.
Detailed description
The study will include 150 patients scheduled to undergo pulmonary vein (PV) ablation because of non-responsive to medical therapy PAF. ECG recordings will be obtained during sinus rhythm before and after PV ablation with a 3 - channel digital recorder for 10 minutes, and digitized with a 16-bit accuracy at a sampling rate of 1000 Hz. The P wave will be analyzed using the Morlet wavelet. Other parameters to be analyzed include 12 lead surface ECG, the burden of main and secondary morphologies and echocardiographic indexes of left atrial mechanical function. Follow-up visits will be held in 3, 6 and 12 months after the ablation procedure.
Interventions
OTHERpulmonary veins ablation's successful outcome
Assessment of predictive factors in patients with successful outcome of pulmonary veins ablations and suffer from paroxysmal atrial fibrillation.
Sponsors
Elpen Pharmaceutical Co. Inc.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Males and Females * Age \>18 years * Paroxysmal AF (PAF) scheduled to undergo pulmonary vein (PV) ablation * Singed written consent form * Patients who will comply with study procedures
Exclusion criteria
* Age \<18 years Permanent atrial fibrillation * Acute myocardial infraction, coronary artery bypass graft surgery or percutaneous transluminal coronary angioplasty within less than 2 months prior to ablation procedure * Life expectancy less than 12 months, according to investigator's judgment * Participation to other clinical trial * Patients who will not be compliant with study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Paroxysmal Atrial Fibrillation (PAF) relapse(s) | 12 months | Primary end point is one or more PAF relapse(s) during a period of 12 months after the ablation procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events | 12 months | Adverse Events occurred during study period |
Countries
Greece
Outcome results
None listed