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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Heart Failure; Atrial Fibrillation
• Intervention / Treatment: Procedure: Ablation

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9700VB
    • University Medical Center Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pulmonary vein isolation; Ablation of the pulmonary veins.	Procedure: Ablation; Ablation of either the pulmonary veins or the atrioventricular node
Active Comparator: atrioventricular node ablation.; Ablation of the atrioventricular node.	Procedure: Ablation; Ablation of either the pulmonary veins or the atrioventricular node

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): April 8, 2024
• Study Completion (Actual): April 8, 2024

Study Registration Dates

• First Submitted: December 22, 2022
• First Submitted That Met QC Criteria: March 6, 2023
• First Posted (Actual): March 8, 2023

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Failure; Atrial Fibrillation
• Other Study ID Numbers: PULVERISE-AF-CRT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No