Left Atrial Low vOltage Zone, GenetIC Markers and Outcomes in Patients After Atrial Fibrillation abLation (LOGICAL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Technische Universität Dresden
Sponsor:
Collaborator:
Landspitali University Hospital
Information provided by (Responsible Party):
Mathias Forkmann, Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT02074826
First received: February 27, 2014
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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
Atrial Fibrillation

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • Association between the suggested genetic AF risk variants and the amount of left atrial low voltage zones [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Fluoroscopy exposure [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Procedural ablation duration [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Association between the proposed genetic markers and the patients clinical characteristics [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Association between the proposed genetic markers and short and long term ablation success [ Time Frame: 6 and 12 months afte inclusion ] [ Designated as safety issue: No ]
  • Association between the proposed genetic markers and hard clinical outcome parameters [ Time Frame: 6 and 12 months after inclusion ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood samples in EDTA plastic vaccutainers will be collected from the study participants for genetic testing


Estimated Enrollment: 1000
Study Start Date: March 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Atrial fibrillation
  • Genotyping of the AF associated variants
  • Measurement of the amount of left atrial fibrosis

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients will be recruited from our primary care clinic

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02074826

Contacts
Contact: Mathias Forkmann, Dr. med. + 49 351 450 1901 mathias.forkmann@mailbox.tu-dresden.de
Contact: Yan Huo, Dr. med. + 49 351 450 1901 dr.huoyan@gmail.com

Locations
Germany
Heart Center Dresden, Depart. of Electrophysiology Recruiting
Dresden, Germany, 01307
Contact: Mathias Forkmann, Dr. med.    + 49 351 450 1901    mathias.forkmann@mailbox.tu-dresden.de   
Contact: Yan Huo, Dr. med.    + 49 351 450 1901    dr.huoyan@gmail.com   
Principal Investigator: Christopher Piorkowski, PD         
Sponsors and Collaborators
Technische Universität Dresden
Landspitali University Hospital
Investigators
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
  More Information

No publications provided

Responsible Party: Mathias Forkmann, Dr. med., Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT02074826     History of Changes
Other Study ID Numbers: GEN-AFIB-REG
Study First Received: February 27, 2014
Last Updated: March 18, 2014
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014