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Status unknownNCT05023590Updated Aug 26, 2021

Atrial Fibrillation Registry 2017

An interventional study of ablation of left atrium during mitral valve open chest intervention in Atrial Fibrillation and Mitral Valve Failure, sponsored by Herz- und Gefaesszentrum Bad Bevensen. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-26.

Sponsored by Herz- und Gefaesszentrum Bad Bevensen · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2021), so the status shown — last known as Enrolling by invitation — may be out of date.

From the registry’s dates

  • Registered 4 years 2 months after the study started (first participant enrolled Feb 2017, registered May 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Atrial Fibrillation
  • Mitral Valve Failure

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Keywords

  • sinus rhythm
  • atrial fibrillation
03

In context

Atrial Fibrillation

3,958 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.

This study's planned enrollment of 50 is below the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

This is the only study on the registry with Herz- und Gefaesszentrum Bad Bevensen as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    cryo ablation

    cryo ablation of left atrium during mitral valve open chest intervention

    Procedure: ablation of left atrium during mitral valve open chest intervention

  • Active comparator
    radio frequency ablation

    radio frequency ablation of left atrium during mitral valve open chest intervention

    Procedure: ablation of left atrium during mitral valve open chest intervention

Interventions

  • Procedureablation of left atrium during mitral valve open chest intervention

    open chest mitral valve surgery (reconstruction or replacement) with additional ablation of left atrium by cryo or radio frequency method

06

What researchers measure

Primary outcomes

  1. number of patients with stabil sinus rhythm 6 month after ablation

    number of patients with stabil sinus rhythm 6 month after ablation

    Time frame: 6 month after index surgery / ablation

07

Study locations

1 site
  • Herz- und Gefaesszentrum Bad Bevensen
    Bad Bevensen, Lower Saxony 29549, Germany
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2017 (actual). Primary completion is estimated for Dec 2022, 70 months after the start.

Of 789 non-industry interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's planned 70 months is above that.

Counting every sponsor, half of 1,031 studies reached it within 34 months; a quarter within 18 and three quarters within 54.

How these figures are worked out, and which studies are left out of them.

Registered
May 5, 2021
First posted
Aug 26, 2021
StartActual
Feb 22, 2017
Primary completionEst.
Dec 30, 2022
CompletionEst.
Jul 31, 2023
Last update
Aug 26, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05023590
Lead sponsor
Herz- und Gefaesszentrum Bad Bevensen
Responsible party
Sponsor
First posted
Aug 26, 2021
Start date
Feb 22, 2017
Primary completion
Dec 30, 2022 (estimated)
Completion
Jul 31, 2023 (estimated)
Last update
Aug 26, 2021

Study contacts

Gerhard Wimmer-Greinecker, Prof.
principal investigator · Herz- und Gefäßzentrum Bad Bevensen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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