Back to resultsAblation in Patients With HF and Symptomatic AF: PULVERISE-AF-CRT
Primary Purpose
Atrial Fibrillation, Heart Failure
Status
Active
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Ablation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
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
Sites / Locations
- University Medical Center Groningen
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Pulmonary vein isolation
atrioventricular node ablation.
Arm Description
Ablation of the pulmonary veins.
Ablation of the atrioventricular node.
Outcomes
Primary Outcome Measures
All-cause death.
Occurence of all-cause death.
cardiovascular hospitalization.
Occurence of cardiovascular hospitalization (heart failure or stroke).
Quality of life
Change in quality of life (using the Kansas City Cardiomyopathy Questionnaire (KCCQ)).
Secondary Outcome Measures
Death from any cause
Occurence of death from any cause.
Unplanned hospitalization
Occurence of unplanned hospitalization related to heart failure.
death from cardiovascular disease
Occurence of death from cardiovascular disease.
cerebrovascular accident.
Occurence of stroke.
unplanned hospitalization for cardiovascular disease
Any unplanned hospitalization for cardiovascular disease.
Any hospitaliation
Any hospitalization for non-cardiovascular disease.
changes in the Kansas city cardiomyopathy questionnaire
Changes in quality of life (any)
procedure related adverse events
Occurence of procedure related adverse events.
atrial fibrillation-free intervals were assessed.
Assessment of AF free intervals.
Full Information
NCT ID
NCT05760833
First Posted
December 22, 2022
Last Updated
March 6, 2023
Sponsor
University Medical Center Groningen
1. Study Identification
Unique Protocol Identification Number
NCT05760833
Brief Title
Ablation in Patients With HF and Symptomatic AF: PULVERISE-AF-CRT
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Medical Center Groningen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pulmonary vein isolation
Arm Type
Active Comparator
Arm Description
Ablation of the pulmonary veins.
Arm Title
atrioventricular node ablation.
Arm Type
Active Comparator
Arm Description
Ablation of the atrioventricular node.
Intervention Type
Procedure
Intervention Name(s)
Ablation
Intervention Description
Ablation of either the pulmonary veins or the atrioventricular node
Primary Outcome Measure Information:
Title
All-cause death.
Description
Occurence of all-cause death.
Time Frame
1 year
Title
cardiovascular hospitalization.
Description
Occurence of cardiovascular hospitalization (heart failure or stroke).
Time Frame
1 year
Title
Quality of life
Description
Change in quality of life (using the Kansas City Cardiomyopathy Questionnaire (KCCQ)).
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Death from any cause
Description
Occurence of death from any cause.
Time Frame
1 year
Title
Unplanned hospitalization
Description
Occurence of unplanned hospitalization related to heart failure.
Time Frame
1 year
Title
death from cardiovascular disease
Description
Occurence of death from cardiovascular disease.
Time Frame
1 year
Title
cerebrovascular accident.
Description
Occurence of stroke.
Time Frame
1 year
Title
unplanned hospitalization for cardiovascular disease
Description
Any unplanned hospitalization for cardiovascular disease.
Time Frame
1 year
Title
Any hospitaliation
Description
Any hospitalization for non-cardiovascular disease.
Time Frame
1 year
Title
changes in the Kansas city cardiomyopathy questionnaire
Description
Changes in quality of life (any)
Time Frame
1 year
Title
procedure related adverse events
Description
Occurence of procedure related adverse events.
Time Frame
1 year
Title
atrial fibrillation-free intervals were assessed.
Description
Assessment of AF free intervals.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9700VB
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Ablation in Patients With HF and Symptomatic AF: PULVERISE-AF-CRT
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