His-pacing and AV-node Ablation vs. Pulmonary Vein Isolation for Atrial Fibrillation (His-PAAF)
Atrial Fibrillation, Left Atrial Dilatation
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Left atrial dilatation, Pulmonary vein isolation, AV node ablation, Conduction System pacing, Quality of Life, Age group 70 to 85 years
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
Sites / Locations
- Linköping University
- Skane University Hospital
- Stockholm Arrhythmia Center
- Varberg HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Conduction System pacing plus AV node ablation
Pulmonary vein isolation
A His-pacing lead in combination with a backup RV pacing lead or an LBB pacing lead, and a right atrial lead (if needed) will be placed using standard technique. The His-pacing or LBB pacing lead will be Medtronic 3830, and the outer sheath will be either Medtronic C304 or C315 deflectable. If failure to implant with these tools, other leads and sheaths can be used at the discretion of the operator. A standard DDD pacemaker or CRT-P device from Medtronic will be used. A minimum of three weeks post-implant, the device will be interrogated and His-bundle threshold will be evaluated. A threshold of ≤2.0V@1.0ms is acceptable. If the device is well-functioning and successful His-pacing is documented, AV node ablation will be performed.
Atrial fibrillation will be performed as a complete pulmonary vein isolation. Either Cryoballon or radio frequency ablation with irrigated tip contact force enabled catheter can be used. Pulsed field ablation can be used if available. Endpoint is complete electrical isolation of all pulmonary veins, verified by entry- and exit block using a multipolar catheter during pacing.