Clinical trial NCT05760833: Ablation in Patients With HF and Symptomatic AF: PULVERISE-AF-CRT
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Atrial Fibrillation
Heart Failure
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: All-cause death.
timeFrame: 1 year
measure: cardiovascular hospitalization.
timeFrame: 1 year
measure: Quality of life
timeFrame: 1 year
Secondary outcomes:
measure: Death from any cause
timeFrame: 1 year
measure: Unplanned hospitalization
timeFrame: 1 year
measure: death from cardiovascular disease
timeFrame: 1 year
measure: cerebrovascular accident.
timeFrame: 1 year
measure: unplanned hospitalization for cardiovascular disease
timeFrame: 1 year
measure: Any hospitaliation
timeFrame: 1 year
measure: changes in the Kansas city cardiomyopathy questionnaire
timeFrame: 1 year
measure: procedure related adverse events
timeFrame: 1 year
measure: atrial fibrillation-free intervals were assessed.
timeFrame: 1 year
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
References: