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

Not Applicable

Withdrawn

• Conditions: Atrial Fibrillation; Heart Failure

• 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

Study Timeline

• Study Start: 2022-12-01
• Study First Submitted: 2022-12-22
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-06
• Study First Posted: 2023-03-08
• Primary Completion: 2024-04-08
• Study Completion: 2024-04-08
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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)).
All-cause death.	1 year	Occurence of all-cause death.

Secondary Outcome Measures

Name	Time	Method
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.
Death from any cause	1 year	Occurence of death from any cause.

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands