Clinical trial NCT04512586: His-pacing and AV-node Ablation vs. Pulmonary Vein Isolation for Atrial Fibrillation
Official title: Physiological Pacemaker Treatment in Combination With AV Node Ablation Compared With Pulmonary Vein Isolation for Patients With Symptomatic Atrial Fibrillation - a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation
Left Atrial Dilatation
Keywords: Atrial fibrillation
Left atrial dilatation
Pulmonary vein isolation
AV node ablation
Conduction System pacing
Quality of Life
Age group 70 to 85 years
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2020-08-13
Enrollment: 45
Sex: ALL
Minimum age (years): 70
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are randomized to either

1. Conduction system pacing via His-pacing electrode, in combination with AV node ablation
2. Pulmonary vein isolation ablation
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Health related Quality of Life: questionnaire
timeFrame: 12 months
Secondary outcomes:
measure: Safety endpoint: Proportion of patients with major adverse events
timeFrame: 12 months
measure: Mental Quality of Life: questionnaire
timeFrame: 12 months
measure: Arrhythmia related Quality of Life: ASTA questionnaire
timeFrame: 12 months
measure: Anxiety and depression
timeFrame: 12 months
measure: Ejection fraction
timeFrame: 12 months
measure: Biomarker for heart failure
timeFrame: 12 months
measure: Physical performance
timeFrame: 12 months
measure: Electrocardiography changes
timeFrame: 12 months
measure: Health economy
timeFrame: 12 months
measure: Survival
timeFrame: 3 years
measure: Hospitalization for heart failure
timeFrame: 3 years
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Linköping University
city: Lund
country: Sweden
facility: Skane University Hospital
city: Stockholm
country: Sweden
facility: Stockholm Arrhythmia Center
city: Varberg
country: Sweden
facility: Varberg Hospital
Study officials:
affiliation: Lund University, Skane University Hospital, Arrhythmia Section, Lund, Sweden
name: Rasmus Borgquist, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: