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

NCT04859933 | Completed

• 1 other identifier: HDZ_ER_003_GI
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Atrial Fibrillation; AV Node Ablation; Escape; Rhythm

Outcome Measures

Primary Outcomes (2)

• AV-node escape rhythm

  intraoperative, follow-up after 1 to 3 month

• bundle branch blocks

  intraoperative, follow-up after 1 to 3 month

Study Arms (2)

AVNA group

Group of historical controls beeing treated with AV-node ablation

Procedure: AV-node ablation

AVNI group

Inculudes all patients beeing treated with AV-node isolation

Procedure: AV-node isolation

Interventions

AV-node isolation PROCEDURE

Abaltion performed in the right atrium isolating the AV-node from the atrium

Also known as: AVNI

AVNI group

AV-node ablation PROCEDURE

Right sided ablation of the AV-node

Also known as: AVNA

AVNA group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Heart and Diabetes Center North-Rhine Westfalia: lead

Study Sites (1)

Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum

Bad Oeynhausen, 32545, Germany

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 26, 2021
• Study Start: October 1, 2020
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: August 9, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)