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

NCT05760833 | Withdrawn DMC

• 1 other identifier: PULVERISE-AF-CRT
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Heart Failure

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Death from any cause

  1 year

• Unplanned hospitalization

  1 year

• death from cardiovascular disease

  1 year

• cerebrovascular accident.

  1 year

• unplanned hospitalization for cardiovascular disease

  1 year

Study Arms (2)

Pulmonary vein isolation

ACTIVE COMPARATOR

Ablation of the pulmonary veins.

Procedure: Ablation

atrioventricular node ablation.

ACTIVE COMPARATOR

Ablation of the atrioventricular node.

Procedure: Ablation

Interventions

Ablation PROCEDURE

Ablation of either the pulmonary veins or the atrioventricular node

Pulmonary vein isolation; atrioventricular node ablation.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9700VB, Netherlands

Location

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: March 8, 2023
• Study Start: December 1, 2022
• Primary Completion: April 8, 2024
• Study Completion: April 8, 2024
• Last Updated: May 17, 2024

Record last verified: 2023-03

Locations

NL (1)