Atrial FibrillationNCT05023590
Atrial Fibrillation Registry 2017
A study testing ablation of left atrium during mitral valve open chest intervention in people with Atrial Fibrillation and Mitral Valve Failure, run by Herz- und Gefaesszentrum Bad Bevensen at 1 site in Germany.
Trial summary
Monocentric, prospective, randomized trial of cardiac surgical arrhythmia using endocardial radiofrequency atrial ablation compared with a cryo ablation system in the setting of cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Mitral Valve Failure
- What is being tested?
- ablation of left atrium during mitral valve open chest intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 22 Feb 2017to 31 Jul 2023
- Phase
- Interventional
- 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
Who may be able to join
- Patients ≥ 18 years
- Present, written informed consent from the patient
- paroxysmal, persistent, or permanent atrial fibrillation not longer than 10 years according to guidelines (ACC, AHA, ESC)
- planned cardiac surgery on the mitral valve
- ECHO parameters : LA size a.p. ≤ 55mm
Who cannot join
- permanent atrial fibrillation longer than 10 years
- ECHO parameters : LA size a.p. > 55mm
- pregnancy
- life expectancy < 12 months
- lack of cognitive or mental capacity to participate in the study
- Patients who are to be included in another clinical (interventional) study at the same time or who are already participating in such a study
Trial locations and contacts
1 site in 1 country.
Germany1 site
Herz- und Gefaesszentrum Bad Bevensen
Bad Bevensen, Lower Saxony, 29549
About this study
Official title: Monocentric, Randomized, Prospective Study to Compare Endocardiac Radio Frequency Ablation and Cryo Ablation of the Left Atrium During an Open Chest Mitral Valve Intervention
Monocentric, prospective, randomized trial of cardiac surgical arrhythmia using endocardial radiofrequency atrial ablation compared with a cryo ablation system in the setting of cardiac surgery.
Read the detailed description
Regular, rhythmic monitoring (24-hour Holter ECG, 5 and 28 days, 3 and 6 months po) of patients after cardiac surgery on the mitral valve with atrial ablation for paroxysmal, persistent, and permanent atrial fibrillation with regard to the presence or stability of sinus rhythm.
- Conditions
- Atrial Fibrillation, Mitral Valve Failure
- Being tested
- ablation of left atrium during mitral valve open chest intervention
- Keywords
- sinus rhythm, atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ablation of left atrium during mitral valve open chest interventionProcedure or surgery
open chest mitral valve surgery (reconstruction or replacement) with additional ablation of left atrium by cryo or radio frequency method
| Study group | Role | What they receive |
|---|---|---|
| cryo ablation | Active comparator | cryo ablation of left atrium during mitral valve open chest intervention Receives: Procedure: ablation of left atrium during mitral valve open chest intervention |
| radio frequency ablation | Active comparator | radio frequency ablation of left atrium during mitral valve open chest intervention Receives: Procedure: ablation of left atrium during mitral valve open chest intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with stabil sinus rhythm 6 month after ablation
number of patients with stabil sinus rhythm 6 month after ablation
Measured: 6 month after index surgery / ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start22 Feb 2017
- Primary completion30 Dec 2022 (estimated)
- Study completion31 Jul 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- monocentric, 1:1 randomized (cryo ablation vs. radiofrequency ablation), open-label, parallel, registry
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herz- und Gefaesszentrum Bad Bevensen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerhard Wimmer-Greinecker, Prof., Principal investigator, Herz- und Gefäßzentrum Bad Bevensen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023590
- Sponsor's protocol ID
- VHA17-Registry
- Status last verified
- Aug 2021
- First submitted
- 5 May 2021
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentric, Randomized, Prospective Study to Compare Endocardiac Radio Frequency Ablation and Cryo Ablation of the Left Atrium During an Open Chest Mitral Valve Intervention
- ClinicalTrials.gov ID
- NCT05023590
- Acronym / sponsor ID
- VHA17-Registry
- Conditions
- Atrial Fibrillation, Mitral Valve Failure
- Keywords
- sinus rhythm, atrial fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Herz- und Gefaesszentrum Bad BevensenUniversity, hospital or other
- Study start
- 22 Feb 2017 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 26 Aug 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.
Monocentric, prospective, randomized trial of cardiac surgical arrhythmia using endocardial radiofrequency atrial ablation compared with a cryo ablation system in the setting of cardiac surgery.
Detailed description
Regular, rhythmic monitoring (24-hour Holter ECG, 5 and 28 days, 3 and 6 months po) of patients after cardiac surgery on the mitral valve with atrial ablation for paroxysmal, persistent, and permanent atrial fibrillation with regard to the presence or stability of sinus rhythm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- monocentric, 1:1 randomized (cryo ablation vs. radiofrequency ablation), open-label, parallel, registry
| Arm | Type | Receives |
|---|---|---|
| cryo ablation | Active comparator | Procedure: ablation of left atrium during mitral valve open chest interventioncryo ablation of left atrium during mitral valve open chest intervention |
| radio frequency ablation | Active comparator | Procedure: ablation of left atrium during mitral valve open chest interventionradio frequency ablation of left atrium during mitral valve open chest intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients ≥ 18 years
- Present, written informed consent from the patient
- paroxysmal, persistent, or permanent atrial fibrillation not longer than 10 years according to guidelines (ACC, AHA, ESC)
- planned cardiac surgery on the mitral valve
- ECHO parameters : LA size a.p. ≤ 55mm
Key exclusion criteria (6 listed)
- permanent atrial fibrillation longer than 10 years
- ECHO parameters : LA size a.p. > 55mm
- pregnancy
- life expectancy < 12 months
- lack of cognitive or mental capacity to participate in the study
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 |
|---|---|---|
| ablation of left atrium during mitral valve open chest interventionopen chest mitral valve surgery (reconstruction or replacement) with additional ablation of left atrium by cryo or radio frequency method | Procedure or surgery | cryo ablation, radio frequency ablation |
Primary outcome
number of patients with stabil sinus rhythm 6 month after ablation
Time frame: 6 month after index surgery / ablation
number of patients with stabil sinus rhythm 6 month after ablation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
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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.
Gerhard Wimmer-Greinecker, Prof. principal investigator
Herz- und Gefäßzentrum Bad Bevensen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ablation of left atrium during mitral valve open chest intervention in people with Atrial Fibrillation and Mitral Valve Failure, run by Herz- und Gefaesszentrum Bad Bevensen 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 5 inclusion and 6 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 26 Aug 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients with stabil sinus rhythm 6 month after ablation (time frame: 6 month after index surgery / ablation). 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 26 Aug 2021.