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New treatment option for Aortic Valve Stenosis
Official title Remote Cardiovascular Monitoring in Post-TAVI Patients
ClinicalTrials.gov ID: NCT06602609
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient age must be 18 years or above.
- Post-TAVI patients without serious complications hindering same-day discharge, including vascular, neurological, and cardiac postprocedural...
- Vascular: Controlled with adequate vascular hemostasis.
- Neurological: Conscious and oriented, not under the effect of residual sedation.
- Cardiac: No significant pericardial effusion.
You likely can't join if
- Hemodynamically unstable post-TAVI condition, periprocedural cardiac arrest, cerebral vascular accident, acute kidney injury (AKI) and...
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- London, United Kingdom
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.