Atrial FibrillationAF GENNCT04753541
The Influence of Genetic Predisposition on Outcome After Catheter Ablation of Atrial Fibrillation.
An observational study of Atrial Fibrillation, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2020to Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients planned for primary ablation due to paroxysmale or persistent atrial fibrillation
Who may be able to join
- patients planned for primary ablation due to paroxysmale or persistent atrial fibrillation
- written informed consent
Who cannot join
- patients under 18 years of age or patients not able to give informed consent
- prior left atrial ablation
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Deutsches Herzzentrum Muenchen
Munich, 80636
Isabel Deisenhofer, MD, +49 89 1218 2020, deisenhofer@dhm.mhn.de
Isabel Deisenhofer, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- no intervention
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
this is not an interventional study
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10ml blood sample taken at baseline visit (routine blood sample)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start1 Nov 2020
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bourier Felix, MD, Principal investigator, Deutsches Herzzentrum München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753541
- Sponsor's protocol ID
- 304/20 S-KH
- Acronym
- AF GEN
- Status last verified
- Feb 2021
- First submitted
- 11 Feb 2021
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Untersuchung Des Einflusses Von Genetischem Risiko Auf Den Erfolg Einer Katheterablation Bei Paroxysmalem Und Persistierendem Vorhofflimmern
- ClinicalTrials.gov ID
- NCT04753541
- Acronym / sponsor ID
- AF GEN / 304/20 S-KH
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 15 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients planned for primary ablation due to paroxysmale or persistent atrial fibrillation
Key inclusion criteria (2 listed)
- patients planned for primary ablation due to paroxysmale or persistent atrial fibrillation
- written informed consent
Key exclusion criteria (2 listed)
- patients under 18 years of age or patients not able to give informed consent
- prior left atrial ablation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionthis is not an interventional study | Other | – |
Primary outcome
Influence of genetic risk on atrial fibrillation
Time frame: 10ml blood sample taken at baseline visit (routine blood sample)
Analysation of the influence of genetic risk on the probability of recurrence of atrial fibrillation after catheter ablation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bourier Felix, MD principal investigator
Deutsches Herzzentrum München
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Felix Bourier, MD (+49891218 ext. 2020, bourier@dhm.mhn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influence of genetic risk on atrial fibrillation (time frame: 10ml blood sample taken at baseline visit (routine blood sample)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2021.