Predictive Factors for Successful Outcome After Pulmonary Veins Ablation to Treat Paroxysmal Atrial Fibrillation

Withdrawn

• Conditions: Atrial Fibrillation

• Registration Number: NCT02614521
• Lead Sponsor: Elpen Pharmaceutical Co. Inc.

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.

Study Timeline

• Study First Submitted: 2015-11-23
• Study First Submitted QC: 2015-11-23
• Study First Posted: 2015-11-25
• Study Start: 2017-01
• Status Verified: 2018-12
• Primary Completion: 2019-02
• Study Completion: 2019-02
• Last Update Submitted: 2019-05-10
• Last Update Posted: 2019-05-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of Adverse Events	12 months	Adverse Events occurred during study period

Trial Locations

Locations (1)

Hippokrateion University Hospital; 🇬🇷 Thessaloniki, Greece