Left Atrial Low vOltage Zone, GenetIC Markers and Outcomes in Patients After Atrial Fibrillation abLation
LOGICAL
Analysis of the Interplay Between Genetic Risk Variants for Atrial Fibrillation and Pathological Changes That Associate With the Disease
1 other identifier
observational
1,000
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2014
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2014
CompletedFirst Posted
Study publicly available on registry
February 28, 2014
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedFebruary 13, 2015
February 1, 2015
2.8 years
February 27, 2014
February 12, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Association between the suggested genetic AF risk variants and the amount of left atrial low voltage zones
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.
baseline
Secondary Outcomes (6)
Fluoroscopy exposure
baseline
Procedural ablation duration
baseline
Freedom from recurrences of AF or MRT (magnetic resonance tomography) after substrate guided AF ablation during follow up
6 and 12 months after inclusion
Association between the proposed genetic markers and the patients clinical characteristics
baseline
Association between the proposed genetic markers and short and long term ablation success
6 and 12 months afte inclusion
- +1 more secondary outcomes
Study Arms (1)
Atrial fibrillation
* Genotyping of the AF associated variants * Measurement of the amount of left atrial fibrosis
Eligibility Criteria
Patients will be recruited from our primary care clinic
You may qualify if:
- Documented atrial fibrillation in 12-lead ECG
- Paroxysmal or persistent symptomatic atrial fibrillation
- Ineffectiveness of antiarrhythmic medication (at least 1 medication) or indication for primary AF ablation according to current guidelines
- Age 18-75 years
You may not qualify if:
- Reversible etiology of atrial fibrillation
- Pregnancy
- Women of childbearing potential without a negative pregnancy test within 48 hours prior to the ablation procedure
- Known intracardiac or other thrombi
- Contraindication to anticoagulation
- Previous left atrial ablation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Technische Universität Dresdenlead
- Landspitali University Hospitalcollaborator
Study Sites (1)
Heart Center Dresden, Depart. of Electrophysiology
Dresden, 01307, Germany
Biospecimen
Blood samples in EDTA plastic vaccutainers will be collected from the study participants for genetic testing
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. med.
Study Record Dates
First Submitted
February 27, 2014
First Posted
February 28, 2014
Study Start
March 1, 2014
Primary Completion
December 1, 2016
Study Completion
December 1, 2017
Last Updated
February 13, 2015
Record last verified: 2015-02