Atrial FibrillationNCT05760833
Ablation in Patients With HF and Symptomatic AF: PULVERISE-AF-CRT
A study testing Ablation in people with Atrial Fibrillation and Heart Failure, run by University Medical Center Groningen at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Heart Failure
- What is being tested?
- Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2022to 8 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Ablation
- Medical subject headings
- Atrial Fibrillation, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AblationProcedure or surgery
Ablation of either the pulmonary veins or the atrioventricular node
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary vein isolation | Active comparator | Ablation of the pulmonary veins. Receives: Procedure: Ablation |
| atrioventricular node ablation. | Active comparator | Ablation of the atrioventricular node. Receives: Procedure: Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause death.
Occurence of all-cause death.
Measured: 1 year
cardiovascular hospitalization.
Occurence of cardiovascular hospitalization (heart failure or stroke).
Measured: 1 year
Quality of life
Change in quality of life (using the Kansas City Cardiomyopathy Questionnaire (KCCQ)).
Measured: 1 year
Secondary outcomes (9)
Death from any cause
Occurence of death from any cause.
Measured: 1 year
Unplanned hospitalization
Occurence of unplanned hospitalization related to heart failure.
Measured: 1 year
death from cardiovascular disease
Occurence of death from cardiovascular disease.
Measured: 1 year
cerebrovascular accident.
Occurence of stroke.
Measured: 1 year
unplanned hospitalization for cardiovascular disease
Any unplanned hospitalization for cardiovascular disease.
Measured: 1 year
Any hospitaliation
Any hospitalization for non-cardiovascular disease.
Measured: 1 year
changes in the Kansas city cardiomyopathy questionnaire
Changes in quality of life (any)
Measured: 1 year
procedure related adverse events
Occurence of procedure related adverse events.
Measured: 1 year
atrial fibrillation-free intervals were assessed.
Assessment of AF free intervals.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start1 Dec 2022
- Primary completion8 Apr 2024
- Study completion8 Apr 2024
Why it stopped: No inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05760833
- Sponsor's protocol ID
- PULVERISE-AF-CRT
- Status last verified
- Mar 2023
- First submitted
- 22 Dec 2022
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05760833
- Acronym / sponsor ID
- PULVERISE-AF-CRT
- Conditions
- Atrial Fibrillation, Heart Failure
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No inclusion
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 8 Apr 2024 (actual)
- Study completion
- 8 Apr 2024 (actual)
- First posted
- 8 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary vein isolation | Active comparator | Procedure: AblationAblation of the pulmonary veins. |
| atrioventricular node ablation. | Active comparator | Procedure: AblationAblation of the atrioventricular node. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AblationAblation of either the pulmonary veins or the atrioventricular node | Procedure or surgery | Pulmonary vein isolation, atrioventricular node ablation. |
Primary outcome
All-cause death.
Time frame: 1 year
Occurence of all-cause death.
cardiovascular hospitalization.
Time frame: 1 year
Occurence of cardiovascular hospitalization (heart failure or stroke).
Quality of life
Time frame: 1 year
Change in quality of life (using the Kansas City Cardiomyopathy Questionnaire (KCCQ)).
9 secondary outcomes
Death from any cause
Time frame: 1 year
Unplanned hospitalization
Time frame: 1 year
death from cardiovascular disease
Time frame: 1 year
cerebrovascular accident.
Time frame: 1 year
unplanned hospitalization for cardiovascular disease
Time frame: 1 year
Any hospitaliation
Time frame: 1 year
changes in the Kansas city cardiomyopathy questionnaire
Time frame: 1 year
procedure related adverse events
Time frame: 1 year
atrial fibrillation-free intervals were assessed.
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Individual participant dataSharing planned: Undecided
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ablation in people with Atrial Fibrillation and Heart Failure, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause death. (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.