The Influence of Genetic Predisposition on Outcome After Catheter Ablation of Atrial Fibrillation.

Atrial Fibrillation Clinical Trial

— AF GEN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04753541
• Other study ID #: 304/20 S-KH
• Status: Recruiting
• Start date: November 1, 2020
• Est. completion date: June 2023

Study information

• Verified date: February 2021
• Source: Deutsches Herzzentrum Muenchen
• Contact: Felix Bourier, MD
• Phone: +49891218
• Email: bourier[@]dhm.mhn.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• no intervention
this is not an interventional study

Locations

Country	Name	City	State
Germany	Deutsches Herzzentrum Muenchen	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)