UnknownNot Applicable

Accelerated Pacing in Patients Undergoing Pace-and-ablate Strategy With LBBAP: a Randomized Controlled Pilot Trial

50 participantsStarted 2024-05

Plain-language summary

The goal of this clinical trial is to determine the effect of accelerated pacing (pacemaker lower rate programmed to 80bpm) compared to pacing at the standard programmed lower rate of 60bpm in symptomatic atrial fibrillation patients undergoing pace-and-ablate strategy with LBBAP. The main question it aims to answer is: \- To determine the effect of accelerated pacing on health-related quality of life compared to the current standard of care. Secondary questions it aims to answer are: * To study the acute hemodynamic effect of different (accelerated) pacing rates on pulmonary capillary wedge pressure, cardiac output and arterial blood pressure among atrial fibrillation patients undergoing pace-and-ablate strategy. * To study the long-term effects (at 6 months) of accelerated pacing compared to the current standard of care among atrial fibrillation patients undergoing pace-and-ablate strategy on: * NT pro BNP levels * device detected atrial fibrillation burden and daily activity * echocardiographic measurements (LVEF, left ventricular ejection fraction; LVEDD, left ventricular end- diastolic diameter; LVESD, left ventricular end-systolic diameter; LAVI left atrial volume index; diastolic parameters; strain

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: * Adults \> 18 years of age * Referred for pace-and-ablate strategy with LBBAP for symptomatic AF * Left ventricular ejection fraction ≥ 40%. * Willingness to participate, to understand the instructions and fill out the questionnaires, and ability to sign informed consent. Exclusion Criteria: * Infiltrative or constrictive cardiomyopathy (cardiac amyloidosis/sarcoidosis/ constrictive pericarditis) * Severe Valvular heart disease (more than moderate valvular stenosis or regurgitation, aortic or mitral valve replacement) * Patient participating in another interventional clinical trial * Recent (\< 3 months) Myocardial infarction (MI), Transient Ischemic Attack or Cerebro- Vascular Accident

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

The effect of accelerated pacing (lower programmed rate of 80 bpm) compared to pacing at the standard programmed rate of 60 bpm on health-related quality of life (HRQoL) in symptomatic AF patients undergoing pace-and-ablate strategy with LBBAP.

Timeframe: 6 months after the AV node ablation

Trial details

NCT IDNCT06377046

SponsorMaastricht University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11

Contact for this trial

Kevin Vernooy, MD, PhD

+31433877095 kevin.vernooy@mumc.nl

View on ClinicalTrials.gov More Atrial Fibrillation trials