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

NCT04512586 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-03-04

No results posted yet for this study

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

Interventions

PROCEDURE

Conduction System pacing and AV node ablation

See study arm description.

PROCEDURE

Atrial fibrillation ablation by pulmonary vein isolation

See study arm description

Sponsors & Collaborators

  • Region Skane

    lead OTHER

Principal Investigators

  • Rasmus Borgquist, MD PhD · Lund University, Skane University Hospital, Arrhythmia Section, Lund, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2025-02-26
Completion
2025-02-26

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04512586 on ClinicalTrials.gov