The Influence of Genetic Predisposition on Outcome After Catheter Ablation of Atrial Fibrillation. (AF GEN)

Untersuchung Des Einflusses Von Genetischem Risiko Auf Den Erfolg Einer Katheterablation Bei Paroxysmalem Und Persistierendem Vorhofflimmern

Catheter ablation is an established standard therapy in interventional treatment of atrial fibrillation.The trial investigates the influence of genetic risk for the recurrence of atrial fibrillation after catheter ablation.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Other: no intervention

Detailed Description

Catheter ablation is an established standard therapy in interventional treatment of atrial fibrillation. electric isolation of the pulmonary veins, from which atrial fibrillation is originating in most patients, is cornerstone of all atrial fibrillation patients.

The most common cause for AF recurrence is still incomplete isolation of the pulmonary veins, on the other hand, only 80% of paroxysmal and 60 % of persistent patients can successfully be cured from atrial fibrillation (despite of isolated pulmonary veins after multiple ablation procedures).

By now, non-procedure related predictive risk factors, resulting in recurrence of atrial fibrillation after catheter ablation, are only partially identified, such as obesity, hypertension and sleep apnea.

In the past year several genetic risk alleles were identified, which are associated with atrial fibrillation. By now the relation between genetic risk, which is determined for every patient by its specific genotype and the outcome of catheter ablation in paroxysmal and persistent atrial fibrillation has not yet been investigated.

The aim is to investigate the influence of genetic risk for the recurrence of atrial fibrillation after catheter ablation.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Felix Bourier, MD; Phone Number: 2020 +49891218; Email: bourier@dhm.mhn.de
• Study Contact Backup: Name: Heike Starkmann; Phone Number: 1192 +49891218; Email: starkmannh@dhm.mhn.de

Study Locations

• Germany
  • Munich, Germany, 80636
    • Recruiting
    • Deutsches Herzzentrum Muenchen
    • Contact: Isabel Deisenhofer, MD; Phone Number: +49 89 1218 2020; Email: deisenhofer@dhm.mhn.de
    • Sub-Investigator: Isabel Deisenhofer, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients planned for primary ablation due to paroxysmale or persistent atrial fibrillation

Description

Inclusion Criteria:

• patients planned for primary ablation due to paroxysmale or persistent atrial fibrillation
• written informed consent

Exclusion Criteria:

• patients under 18 years of age or patients not able to give informed consent
• prior left atrial ablation

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Influence of genetic risk on atrial fibrillation	Analysation of the influence of genetic risk on the probability of recurrence of atrial fibrillation after catheter ablation	10ml blood sample taken at baseline visit (routine blood sample)

Collaborators and Investigators

• Sponsor: Deutsches Herzzentrum Muenchen
• Investigators: Principal Investigator: Bourier Felix, MD, Deutsches Herzzentrum Munchen

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2020
• Primary Completion (ANTICIPATED): June 1, 2023
• Study Completion (ANTICIPATED): June 1, 2023

Study Registration Dates

• First Submitted: February 11, 2021
• First Submitted That Met QC Criteria: February 11, 2021
• First Posted (ACTUAL): February 15, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 15, 2021
• Last Update Submitted That Met QC Criteria: February 11, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 304/20 S-KH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No