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

Not Applicable

Terminated

• Conditions: Left Atrial Dilatation; Atrial Fibrillation

• Registration Number: NCT04512586
• Lead Sponsor: Region Skane

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-01
• Study First Submitted QC: 2020-08-12
• Study First Posted: 2020-08-13
• Study Start: 2020-09-01
• Status Verified: 2024-02
• Primary Completion: 2025-02-26
• Study Completion: 2025-02-26
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-03-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Indication for invasive treatment of symptomatic atrial fibrillation according to current guidelines
• LVEF >35%
• Age 70-85 years
• Persistent atrial fibrillation, or paroxysmal atrial fibrillation with at least moderate enlargement of the left atrium (≥42ml/m2)
• Chronic and well-tolerated treatment with anticoagulants (either non-vitamin K oral anticoagulant or vitamin K antagonist)
• Willingness to participate, to understand the instructions and fill out the questionnaires, and ability to sign informed consent

Exclusion Criteria

• Chronic atrial fibrillation with >1 year duration
• BMI >40kg/m2
• Hypertrophic cardiomyopathy
• Severe heart failure with symptoms ≥ NYHA class IIIb
• Heart amyloidosis
• Cardiac sarcoidosis
• Recent (<3 months) myocardial infarction
• Significant heart valve disease (pronounced insufficiency or stenosis)
• Pacemaker or ICD treatment ongoing, or current pacemaker indication
• Congenital heart disease that required surgical correction
• Comorbidity that is assessed significantly affect the patient's quality of life over the next year, or 3-year survival

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Health related Quality of Life: questionnaire	12 months	Improvement in the Physical Component Summary (PCS) of the SF-36 questionnaire

Secondary Outcome Measures

Name	Time	Method
Physical performance	12 months	Change in six minute walk test distance
Safety endpoint: Proportion of patients with major adverse events	12 months	Proportion of patients with major adverse events that are devicerelated or related to ablation procedure (including but not limited to exit block, infection, perforation/tamponade, pericardial effusion, lead dislodgement, TIA/stroke, oesophago-atrial fistula, groin hematoma or vascular complication, pseudoaneurysm, phrenic nerve injury).
Mental Quality of Life: questionnaire	12 months	Improvement of the "mental" health related quality of life, measured by the mental component summary (MCS) of the SF-36 questionnaire
Hospitalization for heart failure	3 years	Risk of hospitalization for heart failure assessed by Kaplan Meier time dependent analysis using time from ablation to first hospitalization for heart failure within three years
Arrhythmia related Quality of Life: ASTA questionnaire	12 months	Change in arrhythmia related quality of life as measured by the The Arrhythmia-Specific questionnaire in Tachycardia. The ASTA questionnaire consists of 13 items, each with a score of 0-4. A higher score denotes more symptoms associated with the arrhythmia.; and Arrhythmia (ASTA) questionnaire
Anxiety and depression	12 months	Anxiety and depression symptoms, measured by the Hospital Anxiety and Depression Scale (HADS). The scale consists of 14 questions with 0 to 3 points for each, with a higher score denoting more depression/anxiety
Ejection fraction	12 months	Change in left ventricular systolic ejection fraction
Biomarker for heart failure	12 months	Change in NT-ProBNP level
Health economy	12 months	Total atrial fibrillation and device related health care cost
Survival	3 years	Total survival and survival free of major complications
Electrocardiography changes	12 months	Change in QRS duration on ECG

Trial Locations

Locations (4)

Linköping University; 🇸🇪 Linköping, Sweden

Skane University Hospital; 🇸🇪 Lund, Sweden

Stockholm Arrhythmia Center; 🇸🇪 Stockholm, Sweden

Varberg Hospital; 🇸🇪 Varberg, Sweden