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

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05760833
• Other study ID #: PULVERISE-AF-CRT
• Status: Withdrawn
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: April 8, 2024

Study information

• Verified date: March 2023
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 8, 2024
• Est. primary completion date: April 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Failure

Intervention

Procedure:
• Ablation
Ablation of either the pulmonary veins or the atrioventricular node

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause death.	Occurence of all-cause death.	1 year
Primary	cardiovascular hospitalization.	Occurence of cardiovascular hospitalization (heart failure or stroke).	1 year
Primary	Quality of life	Change in quality of life (using the Kansas City Cardiomyopathy Questionnaire (KCCQ)).	1 year
Secondary	Death from any cause	Occurence of death from any cause.	1 year
Secondary	Unplanned hospitalization	Occurence of unplanned hospitalization related to heart failure.	1 year
Secondary	death from cardiovascular disease	Occurence of death from cardiovascular disease.	1 year
Secondary	cerebrovascular accident.	Occurence of stroke.	1 year
Secondary	unplanned hospitalization for cardiovascular disease	Any unplanned hospitalization for cardiovascular disease.	1 year
Secondary	Any hospitaliation	Any hospitalization for non-cardiovascular disease.	1 year
Secondary	changes in the Kansas city cardiomyopathy questionnaire	Changes in quality of life (any)	1 year
Secondary	procedure related adverse events	Occurence of procedure related adverse events.	1 year
Secondary	atrial fibrillation-free intervals were assessed.	Assessment of AF free intervals.	1 year