Atrial Fibrillation Registry 2017

Monocentric, Randomized, Prospective Study to Compare Endocardiac Radio Frequency Ablation and Cryo Ablation of the Left Atrium During an Open Chest Mitral Valve Intervention

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05023590

Enrollment

Registered

2021-08-26

Start date

2017-02-22

Completion date

2023-07-31

Last updated

2021-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Mitral Valve Failure

Keywords

sinus rhythm, atrial fibrillation

Brief 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.

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.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

monocentric, 1:1 randomized (cryo ablation vs. radiofrequency ablation), open-label, parallel, registry

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

* 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

Design outcomes

Primary

Measure	Time frame	Description
number of patients with stabil sinus rhythm 6 month after ablation	6 month after index surgery / ablation	number of patients with stabil sinus rhythm 6 month after ablation

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026