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Recruiting NCT07456280

Pilot Study to Evaluate a Noninvasive Electrocardiographic Monitoring Strategy Associated With Early Discharge in Patients With Conduction Disorders Following TAVI Implantation (IMPROVE Study)

Conditions: Severe Aortic Valve Stenosis, Cardiovascular Diseases

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Location: Hospital Unniversitari Vall d'Hebron Barcelona

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.

Eligibility 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07456280). StuddyBuddy aggregates publicly available trial information.