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

Atrial Fibrillation Clinical Trial

— His-PAAF  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04512586
• Other study ID #: His_PAAF_study
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: Region Skane
• Contact: Rasmus Borgquist, MD PhD
• Phone: +4646171010
• Email: rasmus.borgquist[@]med.lu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Left Atrial Dilatation

Intervention

Procedure:
• Conduction System pacing and AV node ablation
See study arm description.
• Atrial fibrillation ablation by pulmonary vein isolation
See study arm description

Locations

Country	Name	City	State
Sweden	Linköping University	Linköping
Sweden	Skane University Hospital	Lund
Sweden	Stockholm Arrhythmia Center	Stockholm
Sweden	Varberg Hospital	Varberg

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health related Quality of Life: questionnaire	Improvement in the Physical Component Summary (PCS) of the SF-36 questionnaire	12 months
Secondary	Safety endpoint: Proportion of patients with major adverse events	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).	12 months
Secondary	Mental Quality of Life: questionnaire	Improvement of the "mental" health related quality of life, measured by the mental component summary (MCS) of the SF-36 questionnaire	12 months
Secondary	Arrhythmia related Quality of Life: ASTA questionnaire	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	12 months
Secondary	Anxiety and depression	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	12 months
Secondary	Ejection fraction	Change in left ventricular systolic ejection fraction	12 months
Secondary	Biomarker for heart failure	Change in NT-ProBNP level	12 months
Secondary	Physical performance	Change in six minute walk test distance	12 months
Secondary	Electrocardiography changes	Change in QRS duration on ECG	12 months
Secondary	Health economy	Total atrial fibrillation and device related health care cost	12 months
Secondary	Survival	Total survival and survival free of major complications	3 years
Secondary	Hospitalization for heart failure	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	3 years