CompletedNot Applicable

Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post-TAVI

Spain24 participantsStarted 2020-09-14

Plain-language summary

Single-center randomized trial in patients with pacing indication (AV block) after TAVI (transfemoral aortic valve implantation) and LVEF\> 50%, that aims to study the percentage of patients who improve at 12 months in a combined clinical endpoint.

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: * Successful implantation of TAVI according to VARC-2 criteria. * Indication of cardiac pacing due to AV block according to ESC Guidelines. * LVEF\> 50%. * The patient must indicate their acceptance to participate in the study by signing an informed consent document. Exclusion Criteria: * Ventricular dysfunction: LVEF \<50%. * Transapical TAVI. * Participating currently in a clinical investigation that includes an active treatment. * Patients with left bundle branch block but without indication of pacing (AV block). * Life expectancy \<12 months.

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

Clinical combined endpoint: survival; and improvement > 1 point in NYHA class or > 25% increase in the distance covered in the 6-minute walking test.

Timeframe: 12 months

Trial details

NCT IDNCT04482816

SponsorJosep Lluis Mont Girbau

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-30

View on ClinicalTrials.gov More Transcatheter Aortic Valve Implantation trials

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.