Ablation in Patients With HF and Symptomatic AF: PULVERISE-AF-CRT
- Conditions
- Atrial FibrillationHeart Failure
- Interventions
- Procedure: Ablation
- Registration Number
- NCT05760833
- Lead Sponsor
- University Medical Center Groningen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Pulmonary vein isolation Ablation Ablation of the pulmonary veins. atrioventricular node ablation. Ablation Ablation of the atrioventricular node.
- Primary Outcome Measures
Name Time Method All-cause death. 1 year Occurence of all-cause death.
cardiovascular hospitalization. 1 year Occurence of cardiovascular hospitalization (heart failure or stroke).
Quality of life 1 year Change in quality of life (using the Kansas City Cardiomyopathy Questionnaire (KCCQ)).
- Secondary Outcome Measures
Name Time Method Death from any cause 1 year Occurence of death from any cause.
unplanned hospitalization for cardiovascular disease 1 year Any unplanned hospitalization for cardiovascular disease.
changes in the Kansas city cardiomyopathy questionnaire 1 year Changes in quality of life (any)
Unplanned hospitalization 1 year Occurence of unplanned hospitalization related to heart failure.
Any hospitaliation 1 year Any hospitalization for non-cardiovascular disease.
atrial fibrillation-free intervals were assessed. 1 year Assessment of AF free intervals.
death from cardiovascular disease 1 year Occurence of death from cardiovascular disease.
cerebrovascular accident. 1 year Occurence of stroke.
procedure related adverse events 1 year Occurence of procedure related adverse events.
Trial Locations
- Locations (1)
University Medical Center Groningen
🇳🇱Groningen, Netherlands