Left Atrial Low vOltage Zone, GenetIC Markers and Outcomes in Patients After Atrial Fibrillation abLation (LOGICAL)
|ClinicalTrials.gov Identifier: NCT02074826|
Recruitment Status : Unknown
Verified February 2015 by Mathias Forkmann, Technische Universität Dresden.
Recruitment status was: Recruiting
First Posted : February 28, 2014
Last Update Posted : February 13, 2015
This prospective, single-centre cohort study aims to investigate the association between known genetic Atrial Fibrillation (AF) risk variants and the amount of left atrial fibrosis found in patients undergoing clinically indicated AF catheter ablation procedures.
Left atrial fibrosis is increasingly recognized as a fundamental part of the pathomorphological substrate creating an electrophysiological environment needed for electrical conduction heterogeneities. Such identification and treatment of left atrial fibrosis has already entered routine clinical use for RF catheter ablation in an attempt to develop an individualized and tailored treatment strategy. Today, it is unclear what impacts the development, the extent and the localization of left atrial fibrosis in different patients.
A number of genetic risk variants have been described that confer risk of AF and have been widely replicated. This indicates that genetic variants contribute to the risk of the individual to develop AF throughout his life. However, the mechanisms of how genetic variant impact the development of clinical arrhythmias is not yet well understood.
We hypothesize that genetic influences that lead to tissue changes may play a role in the development of the arrhythmia substrate for AF. This is likely to be especially true for those with a relatively brief history of AF and modest clinical disease burden. Therefore, we plan to investigate the association between known genetic AF variants and a detailed disease phenotype obtained from individual left atrial voltage mapping.
|Condition or disease|
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|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1000 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||Analysis of the Interplay Between Genetic Risk Variants for Atrial Fibrillation and Pathological Changes That Associate With the Disease|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2017|
- Association between the suggested genetic AF risk variants and the amount of left atrial low voltage zones [ Time Frame: baseline ]The primary endpoint of the study measures the association between the suggested genetic AF risk variants and the amount of left atrial fibrosis found on detailed endocardial voltage mapping.
- Fluoroscopy exposure [ Time Frame: baseline ]
- Procedural ablation duration [ Time Frame: baseline ]
- Freedom from recurrences of AF or MRT (magnetic resonance tomography) after substrate guided AF ablation during follow up [ Time Frame: 6 and 12 months after inclusion ]
- Association between the proposed genetic markers and the patients clinical characteristics [ Time Frame: baseline ]
- Association between the proposed genetic markers and short and long term ablation success [ Time Frame: 6 and 12 months afte inclusion ]
- Association between the proposed genetic markers and hard clinical outcome parameters [ Time Frame: 6 and 12 months after inclusion ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02074826
|Contact: Mathias Forkmann, Dr. med.||+ 49 351 450 firstname.lastname@example.org|
|Contact: Yan Huo, Dr. med.||+ 49 351 450 email@example.com|
|Heart Center Dresden, Depart. of Electrophysiology||Recruiting|
|Dresden, Germany, 01307|
|Contact: Mathias Forkmann, Dr. med. + 49 351 450 1901 firstname.lastname@example.org|
|Contact: Yan Huo, Dr. med. + 49 351 450 1901 email@example.com|
|Principal Investigator: Christopher Piorkowski, PD|
|Study Chair:||Christopher Piorkowski, PD||Department of Electrophysiology, University of Dresden - Heart Center|
|Study Chair:||David O. Arnar, Dr||Department of Cardiology, Landspitali University Hospital Heart|
|Principal Investigator:||Thomas P Gaspar, Dr.||Department of Electrophysiology, University of Dresden - Heart Center|
|Principal Investigator:||Mathias Forkmann, Dr.||Department of Electrophysiology, University of Dresden - Heart Center|