WithdrawnNot Applicable

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

Stopped: No inclusion

Netherlands0Started 2022-12-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

All-cause death.

Timeframe: 1 year

cardiovascular hospitalization.

Timeframe: 1 year

Quality of life

Timeframe: 1 year

Trial details

NCT IDNCT05760833

SponsorUniversity Medical Center Groningen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-08

View on ClinicalTrials.gov More Atrial Fibrillation trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.