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

University Medical Center Groningen (UMCG)

Status: Withdrawn

Conditions: Atrial Fibrillation; Heart Failure

Treatments: Procedure: Ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT05760833

PULVERISE-AF-CRT

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Pulmonary vein isolation

Active Comparator group

Description:

Ablation of the pulmonary veins.

Treatment:

Procedure: Ablation

atrioventricular node ablation.

Active Comparator group

Description:

Ablation of the atrioventricular node.

Treatment:

Procedure: Ablation