Noninvasive ECG Monitoring to Support Early Discharge After TAVI for Conduction Disorders
Official title: Pilot Study to Evaluate a Noninvasive Electrocardiographic Monitoring Strategy Associated With Early Discharge in Patients With Conduction Disorders Following TAVI Implantation (IMPROVE Study)
Run by Hospital Universitari Vall d'Hebron Research Institute · NCT07456280 · Data updated 2026-11-12
A noninvasive ECG monitoring approach is tested to see if it safely allows patients with conduction issues after TAVI to go home earlier.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Hospital Universitari Vall d'Hebron Research Institute Academic / other |
| Locations | 1 site (Barcelona) |
| Status | Recruiting |
| Started | July 20, 2026 |
| Main results expected | July 1, 2028 |
| Study ends | August 1, 2028 |
| Registry record updated | July 22, 2026 |
| Trial ID | NCT07456280 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older who have undergone successful transfemoral or transaortic TAVI for severe aortic stenosis and have a qualifying conduction disorder with specific QRS criteria or a de novo block, and are clinically stable 24 hours after the procedure.
✕Probably not a fit
Patients without a qualifying conduction disorder or who have hemodynamic instability, high-risk complications, or cannot use the monitoring device may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study tests a non-invasive electrocardiographic monitoring strategy in adults who Develop conduction disorders after transfemoral TAVI for severe aortic stenosis. Participants are assigned to use the PhysioMem PM 100 4G ambulatory monitor to support early discharge versus standard care. The goal is to evaluate safety and potential benefits, including earlier discharge, by continuous remote ECG monitoring. The trial compares outcomes related to safety, feasibility, and likely improvements in hospital stay duration and resource use. It is a pilot with a focus on patients at heightened risk for conduction disturbances after TAVI.
Why it matters
Potential benefit: If successful, patients may be discharged earlier with safe and continuous ECG monitoring, potentially reducing hospital stay and associated costs.
How similar studies have gone: Previous noninvasive monitoring approaches have shown promise in guiding discharge decisions after cardiac procedures, but this specific strategy post-TAVI is exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Hospital Unniversitari Vall d'Hebron
Barcelona, Spain Recruiting
Study contacts
- Study coordinator: Bruno García del Blanco, MD, PhD
- Email: bruno.garcia@vallhebron.cat
- Phone: 00342746155
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Abnormal menstrual bleeding in women on antithrombotic drugs after heart surgery
This study looks at whether women on blood thinners after heart surgery have abnormal menstrual bleeding and what factors might put some at higher risk.
-
AI-powered ECG to help diagnose and predict outcomes in heart disease
Researchers test an AI-enhanced ECG to help diagnose and predict outcomes for people with cardiovascular diseases.
-
Colchicine for preventing cardiovascular disease in adults with type 2 diabetes
A 24-week study will test whether low-dose colchicine can help protect blood vessels in adults with type 2 diabetes who have not yet developed artery disease, compared with a placebo.
-
Optimised Cardio-Renal Care for CKD and heart disease
This study tests whether a specialised Cardio-Renal Clinic can improve heart and kidney health and quality of life for adults with chronic kidney disease and cardiovascular disease.
-
Inhaled mosliciguat for pulmonary hypertension in interstitial lung disease (PH-ILD) patients
This study tests inhaled mosliciguat versus placebo in people with PH-ILD to see if it helps with their condition.
-
One-stop photon-counting CT for patients after PCI
This study tests a single CT exam using photon-counting technology to image the heart after stent placement in people who have had PCI.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.