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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04859933
Other study ID # HDZ_ER_003_GI
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date February 28, 2022

Study information

Verified date August 2022
Source Heart and Diabetes Center North-Rhine Westfalia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date February 28, 2022
Est. primary completion date February 28, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
AV-node isolation
Abaltion performed in the right atrium isolating the AV-node from the atrium
AV-node ablation
Right sided ablation of the AV-node

Locations

Country Name City State
Germany Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum Bad Oeynhausen

Sponsors (1)

Lead Sponsor Collaborator
Heart and Diabetes Center North-Rhine Westfalia

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary AV-node escape rhythm intraoperative, follow-up after 1 to 3 month
Primary bundle branch blocks intraoperative, follow-up after 1 to 3 month
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