AV Node Isolation in Atrial Fibrillation vs. Modulation by "Pace and Ablate" Strategy

AV-node ablation (AVNA) is a common therapy option for rate control strategy of permanent atrial fibrillation with numerous side effects. The investigators hypothesised that an isolation of the AV node is concomitant with less occurrence of new bundle brunch blocks, more frequent preservation and higher rate of escape rhythm compared to AVNA. This retrospective study includes 20 patients being treated with AV-node isolation (AVNI) and 40 historical AVNA-controls. Among others these two methods were compared regarding escape rhythm, delta QRS, procedure time, ablation points, fluoroscopy time and total dose area product (DAP).

Study Overview

Study Type

Observational

Enrollment (Actual)

60

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

      • Bad Oeynhausen, Germany, 32545
        • Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum

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 to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to Heart- and Diabetes Centre NRW for AV-node ablation/isolation.

Description

Inclusion Criteria:

  • paroxysmal, persistend or permanent atrial fibrillation; indication for AVNA

Exclusion Criteria:

  • other indications for AVNA than atrial fibrillation as AVNRT, atrial flutter, atrial tachycardia

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AVNA group
Group of historical controls beeing treated with AV-node ablation
Right sided ablation of the AV-node
Other Names:
  • AVNA
AVNI group
Inculudes all patients beeing treated with AV-node isolation
Abaltion performed in the right atrium isolating the AV-node from the atrium
Other Names:
  • AVNI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AV-node escape rhythm
Time Frame: intraoperative, follow-up after 1 to 3 month
intraoperative, follow-up after 1 to 3 month
bundle branch blocks
Time Frame: intraoperative, follow-up after 1 to 3 month
intraoperative, follow-up after 1 to 3 month

Collaborators and Investigators

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

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)

October 1, 2020

Primary Completion (Actual)

February 28, 2022

Study Completion (Actual)

February 28, 2022

Study Registration Dates

First Submitted

April 22, 2021

First Submitted That Met QC Criteria

April 22, 2021

First Posted (Actual)

April 26, 2021

Study Record Updates

Last Update Posted (Actual)

August 9, 2022

Last Update Submitted That Met QC Criteria

August 8, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • HDZ_ER_003_GI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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