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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04859933
• Other study ID #: HDZ_ER_003_GI
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Atrial Fibrillation

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