An observational study in Atrial Fibrillation, sponsored by Elpen Pharmaceutical Co. Inc.. Withdrawn at 1 site in Greece. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-05-13.
Sponsored by Elpen Pharmaceutical Co. Inc. · Observational
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.
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
Browse Atrial Fibrillation studies →Elpen Pharmaceutical Co. Inc. is the lead sponsor of 43 studies on the registry; 7 are open to participants now.
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Patients with paroxysmal atrial fibrillation
Exclusion Criteria:
Assessment of predictive factors in patients with successful outcome of pulmonary veins ablations and suffer from paroxysmal atrial fibrillation.
Number of Paroxysmal Atrial Fibrillation (PAF) relapse(s)
Primary end point is one or more PAF relapse(s) during a period of 12 months after the ablation procedure.
Time frame: 12 months
Number of Adverse Events
Adverse Events occurred during study period
Time frame: 12 months
Plan to share: No
This study is withdrawn, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Elpen Pharmaceutical Co. Inc.