NCT04512586

His-pacing and AV-node Ablation vs. Pulmonary Vein Isolation for Atrial Fibrillation

Physiological Pacemaker Treatment in Combination With AV Node Ablation Compared With Pulmonary Vein Isolation for Patients With Symptomatic Atrial Fibrillation - a Randomized Controlled Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Region Skane · Academic / Other
• Sex: All
• Age: 70 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Objective To investigate if conduction system pacing ((CSP) i.e. atrioventricular node ablation + His bundle pacing or Left Bundle Branch pacing) is as good as (or better than) atrial fibrillation ablation with pulmonary vein isolation for older patients (70-85yrs) with symptomatic atrial fibrillation and at least moderately dilated left atrium. Patient population: 90 patients aged 70-85 years with atrial fibrillation, referred to either AV node ablation or pulmonary vein isolation. Primary endpoint: Improvement in health-related quality of life as measured by the physical component summary (PCS) of the well-validated SF-36 form, at one year after AV node ablation + CSP or AF ablation. Secondary endpoints: Physical performance measured by 6-minute walk test, biochemical markers of heart failure (NT-ProBNP), frequency of complications, left ventricular systolic and diastolic function, and left atrial size evaluated after 12 months. Arrhythmia specific symptoms and anxiety will be measured with the ASTA and HADS questionnaires. Arrhythmia symptom correlation between subjective and objective findings. After three years, clinical endpoints will be evaluated regarding overall survival, and risk of heart failure hospitalization or death. The cost of the treatments will be compared, and estimated cost per quality adjusted year of life will be calculated, based on the EQ5D questionnaire.

Conditions

• Atrial Fibrillation
• Left Atrial Dilatation

Interventions

Type	Name	Description
PROCEDURE	Conduction System pacing and AV node ablation	See study arm description.
PROCEDURE	Atrial fibrillation ablation by pulmonary vein isolation	See study arm description

Timeline

• Start date: 2020-09-01
• Primary completion: 2025-02-26
• Completion: 2025-02-26
• First posted: 2020-08-13
• Last updated: 2025-03-04

Locations

4 sites across 1 country: Sweden