Clinical trial NCT02614521: Predictive Factors for Successful Outcome After Pulmonary Veins Ablation to Treat Paroxysmal Atrial Fibrillation
Official title: A Single-center, Observational, 12-months Study to Examine the Predictive Factors for Successful Outcome After Pulmonary Veins Ablation to Treat Patients With Paroxysmal Atrial Fibrillation.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Atrial Fibrillation
Keywords: Pulmonary veins ablation
Paroxysmal atrial fibrillation
Lead sponsor: Elpen Pharmaceutical Co. Inc.
Sponsor class: INDUSTRY
First posted: 2015-11-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Paroxysmal Atrial Fibrillation (PAF) relapse(s)
timeFrame: 12 months
Secondary outcomes:
measure: Number of Adverse Events
timeFrame: 12 months
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Hippokrateion University Hospital
Study officials:
affiliation: Aristoteleion University of Thessaloniki, Hippokrateion Hospital
name: Vassilios P Vassilikos, MD, FACC
role: STUDY_CHAIR
References:
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