Atrial Fibrillation Clinical Trial
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.
NCT number | NCT02614521 |
Other study ID # | 2015-IIS-GR-AF |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | January 2017 |
Est. completion date | February 2019 |
Verified date | December 2018 |
Source | Elpen Pharmaceutical Co. Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | 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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | February 2019 |
Est. primary completion date | February 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Greece | Hippokrateion University Hospital | Thessaloniki |
Lead Sponsor | Collaborator |
---|---|
Elpen Pharmaceutical Co. Inc. |
Greece,
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Camm AJ, Lip GY, De Caterina R, Savelieva I, Atar D, Hohnloser SH, Hindricks G, Kirchhof P; ESC Committee for Practice Guidelines (CPG). 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation. Developed with the special contribution of the European Heart Rhythm Association. Eur Heart J. 2012 Nov;33(21):2719-47. doi: 10.1093/eurheartj/ehs253. Epub 2012 Aug 24. Erratum in: Eur Heart J. 2013 Mar;34(10):790. Eur Heart J. 2013 Sep;34(36):2850-1. — View Citation
Ketels S, Houben R, Van Beeumen K, Tavernier R, Duytschaever M. Incidence, timing, and characteristics of acute changes in heart rate during ongoing circumferential pulmonary vein isolation. Europace. 2008 Dec;10(12):1406-14. doi: 10.1093/europace/eun287. Epub 2008 Oct 19. — View Citation
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Martínez A, Alcaraz R, Rieta JJ. Application of the phasor transform for automatic delineation of single-lead ECG fiducial points. Physiol Meas. 2010 Nov;31(11):1467-85. doi: 10.1088/0967-3334/31/11/005. Epub 2010 Sep 24. — View Citation
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Oral H. Mechanisms of atrial fibrillation: lessons from studies in patients. Prog Cardiovasc Dis. 2005 Jul-Aug;48(1):29-40. Review. — View Citation
Ouyang F, Antz M, Ernst S, Hachiya H, Mavrakis H, Deger FT, Schaumann A, Chun J, Falk P, Hennig D, Liu X, Bänsch D, Kuck KH. Recovered pulmonary vein conduction as a dominant factor for recurrent atrial tachyarrhythmias after complete circular isolation of the pulmonary veins: lessons from double Lasso technique. Circulation. 2005 Jan 18;111(2):127-35. Epub 2004 Dec 27. — View Citation
Packer DL, Kowal RC, Wheelan KR, Irwin JM, Champagne J, Guerra PG, Dubuc M, Reddy V, Nelson L, Holcomb RG, Lehmann JW, Ruskin JN; STOP AF Cryoablation Investigators. Cryoballoon ablation of pulmonary veins for paroxysmal atrial fibrillation: first results of the North American Arctic Front (STOP AF) pivotal trial. J Am Coll Cardiol. 2013 Apr 23;61(16):1713-23. doi: 10.1016/j.jacc.2012.11.064. Epub 2013 Mar 21. — View Citation
Pappone C, Rosanio S, Oreto G, Tocchi M, Gugliotta F, Vicedomini G, Salvati A, Dicandia C, Mazzone P, Santinelli V, Gulletta S, Chierchia S. Circumferential radiofrequency ablation of pulmonary vein ostia: A new anatomic approach for curing atrial fibrillation. Circulation. 2000 Nov 21;102(21):2619-28. — View Citation
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 12 months | |
Secondary | Number of Adverse Events | Adverse Events occurred during study period | 12 months |
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