NCT04753541

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 15, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

February 15, 2021

Status Verified

February 1, 2021

Enrollment Period

2.6 years

First QC Date

February 11, 2021

Last Update Submit

February 11, 2021

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • 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)

Interventions

no interventionOTHER

this is not an interventional study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deutsches Herzzentrum Muenchen

Munich, 80636, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

10 ml EDTA-blood routine samples taken will be analysed for risk allele loci associated with atrial fibrillation

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bourier Felix, MD

    Deutsches Herzzentrum München

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Felix Bourier, MD

CONTACT

+49891218bourier@dhm.mhn.de

Heike Starkmann

CONTACT

+49891218starkmannh@dhm.mhn.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2021

First Posted

February 15, 2021

Study Start

November 1, 2020

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

February 15, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)