CompletedNot Applicable

Impact of Atrio-ventricular Optimization With His Bundle Pacing on Treatment of Atrio-ventricular Dromotropathy

Slovenia17 participantsStarted 2019-12-23

Plain-language summary

This study aims to determine the clinical and hemodynamic benefit of atrio-ventricular (AV) resynchronization with His bundle pacing in patients with symptomatic first degree AV block.

Who can participate

Age range

18 Years – 80 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: * First OR second degree Mobitz type 1 atrioventricular block with a PR interval \> 250 ms * left ventricular ejection fraction \> 50% * echocardiographic criteria of atrioventricular dyssynchrony (diastolic filling time/RR interval ratio \< 0,4 OR fusion of E and A waves OR diastolic mitral regurgitation) * symptoms on exertion (dyspnea, palpitations) * insufficient shortening of PR interval during exercise (PR interval \> 200 ms at heart rate of 100 beats per minute) Exclusion Criteria: * left ventricular ejection fraction \< 50% * third degree atrioventricular block * atrial fibrillation * sinus node disease * left bundle branch block * right bundle branch block * ventricular arrhythmia that indicates implantation of cardioverter defibrillator * consumption of drugs that influence atrioventricular conduction * active bacterial infection * inability to undergo cardiopulmonary exercise test * anaemia (haemoglobin concentration \< 100 g/L) * pregnancy

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

Changes in exercise capacity

Timeframe: Baseline, 3 months, 6 months

Changes in left ventricular stroke volume

Timeframe: Baseline, 3 months, 6 months

Changes in quality of life using the 5 level EQ-5D questionnaire

Timeframe: Baseline, 3 months, 6 months

Trial details

NCT IDNCT04544345

SponsorUniversity Medical Centre Ljubljana

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-13

View on ClinicalTrials.gov More Atrioventricular Block trials

Who can participate

Age range

18 Years – 80 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.