Ablation in Patients With HF and Symptomatic AF: PULVERISE-AF-CRT

Study Overview
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Brief Summary
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Pulmonary vein isolation (PVI) is currently the cornerstone non pharmacological therapy for drug-refractory atrial fibrillation (AF). Where rhythm control has been shown to be inferior as compared to rate control in older trials. New data suggest that for patients with heart failure and AF PVI may improve prognosis (mortality) as compared to medical rate or rhythm control. Whether optimal rate control as can be achieved with atrioventricular node ablation is comparable with regard to all-cause mortality of heart failure hospitalization to PVI in patients with heart failure and AF is unknown.

Official Title
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Pulmonary Vein Isolation or Atrioventricular Node Ablation in Patients With Heart Failure and Symptomatic Atrial Fibrillation Diminishing CRT Response (PULVERISE-AF-CRT): a Randomized Study

Conditions
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Heart Failure, Atrial Fibrillation

Intervention / Treatment
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* Procedure: Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of a cardiac resynchronization therapy device (CRT-D or CRT-P) and optimal medical therapy according to current guidelines. Patients with paroxysmal or persistent AF, having AF or HF related symptoms. Patient with paroxysmal AF should have >25% burden or inadequate biventricular pacing (<95%) based on device counters. The patient is willing and able to comply with the protocol and has provided written informed consent. Age ≥ 18 years Exclusion Criteria: Documented left atrial diameter > 6 cm (parasternal long axis). Longstanding persistent AF longer than 2 years. Contraindication to chronic anticoagulation therapy or heparin Previous left heart ablation procedure for AF Acute coronary syndrome, cardiac surgery, angioplasty or stroke within 2 months prior to enrolment Untreated hypothyroidism or hyperthyroidism Enrolment in another investigational drug or device study. Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertility age. Mental or physical inability to participate in the study. Listed for heart transplant. Cardiac assist device implanted. Planned cardiovascular intervention. Life expectancy ≤ 12 months. Uncontrolled hypertension. Requirement for dialysis due to terminal renal failure. Participation in another telemonitoring concept

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pulmonary vein isolation<br>Ablation of the pulmonary veins. | Procedure: Ablation<br>* Ablation of either the pulmonary veins or the atrioventricular node<br>|
| Active Comparator: atrioventricular node ablation.<br>Ablation of the atrioventricular node. | Procedure: Ablation<br>* Ablation of either the pulmonary veins or the atrioventricular node<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause death. | Occurence of all-cause death. | 1 year | 
| cardiovascular hospitalization. | Occurence of cardiovascular hospitalization (heart failure or stroke). | 1 year | 
| Quality of life | Change in quality of life (using the Kansas City Cardiomyopathy Questionnaire (KCCQ)). | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death from any cause | Occurence of death from any cause. | 1 year | 
| Unplanned hospitalization | Occurence of unplanned hospitalization related to heart failure. | 1 year | 
| death from cardiovascular disease | Occurence of death from cardiovascular disease. | 1 year | 
| cerebrovascular accident. | Occurence of stroke. | 1 year | 
| unplanned hospitalization for cardiovascular disease | Any unplanned hospitalization for cardiovascular disease. | 1 year | 
| Any hospitaliation | Any hospitalization for non-cardiovascular disease. | 1 year | 
| changes in the Kansas city cardiomyopathy questionnaire | Changes in quality of life (any) | 1 year | 
| procedure related adverse events | Occurence of procedure related adverse events. | 1 year | 
| atrial fibrillation-free intervals were assessed. | Assessment of AF free intervals. | 1 year |