Evaluation of the Non-invasive Electrocardiographic Monitoring Strategy Associated With Early Dis… (NCT07456280) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluation of the Non-invasive Electrocardiographic Monitoring Strategy Associated With Early Discharge in Patients With Conduction Disorder Through TAVI Implantation
Spain100 participantsStarted 2026-04-01
Plain-language summary
Study to evaluate the efficacy and safety of a non-invasive electrocardiographic monitoring strategy associated with early discharge in patients with conduction disorder after transfemoral TAVI implantation, and its potential benefits compared to standard care.
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:
All inclusion criteria must be met
* Age ≥ 18 years and
* Undergone successful transfemoral or transaortic TAVI for severe aortic stenosis and
* Presence of at least one of the following conduction disorders and
* Pre-procedural basal conduction disorder (e.g., right/left bundle branch block, bifascicular block, IVCD) with QRS between 120-160 msec.
* De novo conduction disorder after TAVI (de novo bundle branch block) with QRS between 120-160 msec.
* Clinical stability at 24 hours post-procedure and
* Capacity to give informed consent.
Exclusion Criteria:
No exclusion criteria must be met
* Immediate indication for permanent pacemaker following the procedure.
* Persistent complete atrioventricular block.
* QRS \>160 msec and/or PR prolongation.
* Haemodynamic instability or complications of TAVI (major bleeding, stroke, decompensated heart failure) that contraindicate early discharge.
* Technical or clinical impossibility of using the PhysioMem PM 1004G monitoring system.
* Life expectancy \< 12 months due to non-cardiovascular comorbidity.
* Refusal or inability to undergo outpatient follow-up.
* Pregnant or breastfeeding.
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
1
Composite of all-cause death and rehospitalization for any reason
Timeframe: 30 days
2
Clinically relevant arrhythmic event requiring a change in therapy
Timeframe: 30 days
Trial details
NCT IDNCT07456280
SponsorHospital Universitari Vall d'Hebron Research Institute