CompletedNot Applicable

"Hypotension Probability Indicator" in TAVI/MitraClip for Hypotension Management

Greece100 participantsStarted 2024-01-10

Plain-language summary

The study will investigate whether the use of Goal Directed Hemodynamic Therapy implemented with the HPI algorithm using a treatment algorithm will reduce the incidence of hypotension and improve treatment of hypotension.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age \>18 years * Will be monitored intraoperatively for \>1 hour or will receive general anesthesia for \>1 hour * Will undergo intraoperative monitoring with invasive arterial pressure measurement * Mean arterial pressure (MAP) target will be ≥ 65 mmHg intraoperatively * Will sign written informed consent preoperatively * Will undergo TAVI or Mitral Clip under general anesthesia or monitored anesthesia care (MAC) and sedation * American Society of Anesthesiologists (ASA) Physical Status ≤ 4 Exclusion Criteria: * Target for MAP different from 65 mmHg * Severe hypotension preoperatively MAP \<65 mmHg * Severe heart failure (e.g., Left Ventricular Ejection Fraction\<20%) * Patients needing or will need mechanical circulatory support postoperatively (e.g., intra-aortic pump) * Urgent surgery * Patients with severe pulmonary hypertension (preexisting or detected intraoperatively) * Patients with hemodynamic instability requiring extracorporeal circulation support

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

TWA hypotension (measured with Acumen IQ sensor)

Timeframe: Intraoperatively,10 min after induction of anesthesia or commencement of sedation

Trial details

NCT IDNCT06347211

SponsorAttikon Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-10

View on ClinicalTrials.gov More Hypotension During Surgery trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.