Atrial Fibrillation Registry 2017

NCT05023590 | Unknown

• 1 other identifier: VHA17-Registry
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Mitral Valve Failure

Keywords

sinus rhythm; atrial fibrillation

Outcome Measures

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

  6 month after index surgery / ablation

Study Arms (2)

cryo ablation

ACTIVE COMPARATOR

cryo ablation of left atrium during mitral valve open chest intervention

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

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

Interventions

ablation of left atrium during mitral valve open chest intervention PROCEDURE

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

cryo ablation; radio frequency ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Herz- und Gefaesszentrum Bad Bevensen: lead

Study Sites (1)

Herz- und Gefaesszentrum Bad Bevensen

Bad Bevensen, Lower Saxony, 29549, Germany

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gerhard Wimmer-Greinecker, Prof.

  Herz- und Gefäßzentrum Bad Bevensen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: August 26, 2021
• Study Start: February 22, 2017
• Primary Completion: December 30, 2022
• Study Completion: July 31, 2023
• Last Updated: August 26, 2021

Record last verified: 2021-08

Locations

DE (1)