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

• Sponsor: University Medical Center Groningen (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05760833
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation; Heart Failure	Procedure: Ablation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Dec 1, 2022
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Dec 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. All-cause death. [1 year]

   Occurence of all-cause death.

2. cardiovascular hospitalization. [1 year]

   Occurence of cardiovascular hospitalization (heart failure or stroke).

3. Quality of life [1 year]

   Change in quality of life (using the Kansas City Cardiomyopathy Questionnaire (KCCQ)).

Secondary Outcome Measures

1. Death from any cause [1 year]

   Occurence of death from any cause.

2. Unplanned hospitalization [1 year]

   Occurence of unplanned hospitalization related to heart failure.

3. death from cardiovascular disease [1 year]

   Occurence of death from cardiovascular disease.

4. cerebrovascular accident. [1 year]

   Occurence of stroke.

5. unplanned hospitalization for cardiovascular disease [1 year]

   Any unplanned hospitalization for cardiovascular disease.

6. Any hospitaliation [1 year]

   Any hospitalization for non-cardiovascular disease.

7. changes in the Kansas city cardiomyopathy questionnaire [1 year]

   Changes in quality of life (any)

8. procedure related adverse events [1 year]

   Occurence of procedure related adverse events.

9. atrial fibrillation-free intervals were assessed. [1 year]

   Assessment of AF free intervals.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Medical Center Groningen	Groningen		Netherlands	9700VB

Sponsors and Collaborators

• University Medical Center Groningen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Medical Center Groningen
• ClinicalTrials.gov Identifier: NCT05760833
• Other Study ID Numbers: PULVERISE-AF-CRT
• First Posted: Mar 8, 2023
• Last Update Posted: Mar 8, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Heart Failure; Atrial Fibrillation

Study Results

No Results Posted as of Mar 8, 2023