NCT06602609 Remote Cardiovascular Monitoring in Post-TAVI Patients
| NCT ID | NCT06602609 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Imperial College London |
| Condition | Aortic Valve Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 216 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 216 participants in total. It began in 2024-11-01 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this randomised clinical trial is to utilise a remote monitoring algorithm to gather essential clinical data, aiming to guide the management of post-Transcatheter Aortic Valve Implantation (TAVI) patients and reduce both postprocedural hospital length of stay and readmissions. This strategic integration of technology aims to address gaps identified in previous studies and enhance the effectiveness of post-TAVI patient care. One significant concern after TAVI is the development of heart conduction abnormalities on the ECG and abnormal rhythms, such as heart block, potentially requiring permanent pacemaker insertion. Addressing these rhythm issues is crucial for reducing the overall length of stay. The main question it aims to answer is: Does a remote patient monitoring protocol-driven strategy reduce post-TAVI hospital length of stay and adverse events? Participants post-TAVI procedure and eligible for same-day discharge, as determined by their primary cardiologist, will be randomized upon informed consent into the active arm (remote monitoring) or control group (standard of care). Participants in the active arm will: receive four remote monitoring devices. Receive support from a validated clinical decision-making algorithm for further management. Participants in the control group will: adhere to the best standard of care as per current practice. Researchers will compare the active arm to the control group to see if the remote patient monitoring protocol-driven strategy reduces post-TAVI hospital length of stay and adverse events.
Eligibility 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.
Contact & Investigator
Ramzi Khamis, MBChB DIC PhD FESC FRCP
PRINCIPAL INVESTIGATOR
Imperial College London, Imperial College Healthcare NHS Trust
Frequently Asked Questions
Who can join the NCT06602609 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aortic Valve Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06602609 currently recruiting?
Yes, NCT06602609 is actively recruiting participants. Contact the research team at b.al-harbi23@imperial.ac.uk for enrollment information.
Where is the NCT06602609 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT06602609 clinical trial?
NCT06602609 is sponsored by Imperial College London. The principal investigator is Ramzi Khamis, MBChB DIC PhD FESC FRCP at Imperial College London, Imperial College Healthcare NHS Trust. The trial plans to enroll 216 participants.