Atrial Fibrillation Registry 2017

August 24, 2021 updated by: Herz- und Gefaesszentrum Bad Bevensen

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
open chest mitral valve surgery (reconstruction or replacement) with additional ablation of left atrium by cryo or radio frequency method
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
open chest mitral valve surgery (reconstruction or replacement) with additional ablation of left atrium by cryo or radio frequency method

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 month after index surgery / ablation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herz- und Gefaesszentrum Bad Bevensen

Investigators

  • Principal Investigator: Gerhard Wimmer-Greinecker, Prof., Herz- und Gefasszentrum Bad Bevensen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2017

Primary Completion (Anticipated)

December 30, 2022

Study Completion (Anticipated)

July 31, 2023

Study Registration Dates

First Submitted

May 5, 2021

First Submitted That Met QC Criteria

August 24, 2021

First Posted (Actual)

August 26, 2021

Study Record Updates

Last Update Posted (Actual)

August 26, 2021

Last Update Submitted That Met QC Criteria

August 24, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VHA17-Registry

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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