Remote monitoring for patients after heart valve replacement
Remote Acute Monitoring-based Same-day Discharge Strategy of Post Transcatheter Aortic Valve Implantation Patients Versus Standard Care at 30-Day Follow-up
This study tests if using remote monitoring can help patients who have had heart valve replacement recover better and go home sooner by catching any problems early.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 216 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Imperial College London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT06602609 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to implement a remote monitoring algorithm to collect vital clinical data for patients who have undergone Transcatheter Aortic Valve Implantation (TAVI). By utilizing technology, the study seeks to reduce hospital length of stay and readmissions by addressing potential heart conduction issues that may arise post-procedure. Eligible patients will be monitored remotely to predict and manage any complications, allowing for same-day discharge when appropriate. The trial will assess whether this approach can effectively enhance patient care and outcomes following TAVI.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone TAVI without serious complications and are eligible for same-day discharge.
Not a fit: Patients with hemodynamic instability or significant complications post-TAVI that require inpatient care will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to shorter hospital stays and improved management of post-TAVI complications for patients.
How similar studies have performed: Previous studies have shown promise in using remote monitoring for post-operative care, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient age must be 18 years or above. * Post-TAVI patients without serious complications hindering same-day discharge, including vascular, neurological, and cardiac postprocedural complications necessitating inpatient care: * Vascular: Controlled with adequate vascular hemostasis. * Neurological: Conscious and oriented, not under the effect of residual sedation. * Cardiac: No significant pericardial effusion. * Elective non-emergent patient admission and nonelective cases fitting discharge criteria. * Comfortable ambulation post-procedure. * The patient or their caregiver must have access to a smart device. * Ability to provide informed consent (the patient must be alert and oriented for consent). * Adequate social support. Exclusion Criteria: * Hemodynamically unstable post-TAVI condition, periprocedural cardiac arrest, cerebral vascular accident, acute kidney injury (AKI) and major/life-threatening bleeding requiring blood transfusion. * Patients with a permanent (pre-existing or new) implanted pacing device. * Procedural failure in device delivery. * Major vascular access complications require patients to stay. * Inability to engage with the technology. * Significant communication barrier.
Where this trial is running
London
- Hammersmith Hospital — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Ramzi Khamis, MBChB DIC PhD FESC FRCP — Imperial College London, Imperial College Healthcare NHS Trust
- Study coordinator: Badr Al Harbi, BScEMS, MSc
- Email: b.al-harbi23@imperial.ac.uk
- Phone: +44(0)7771429219
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.