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Prospective comparative randomized study of procedural sedation during TAVR (Transcatheter Aortic Valve Replacement)
EU CTIS ID: 2024-511018-18-00
What this study is testing
- Determine if there are differences in the incidence of intra-procedural respiratory acidosis. - Determine if there are differences in the incidence of emergence delirium within the first 24 hours following the end of the procedure.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients undergoing TAVR
- Age between 18 and 95 years.
- Patient's agreement to participate in the protocol and to sign the informed consent form.
You likely can't join if
- Lack of informed consent
- Acute cerebrovascular conditions;
- Advanced heart failure.
- allergies to sedative medications used or to any of the excipients
- presence of preoperative delirium
- Patients with psychiatric disorders on pharmacological therapy;
See the full eligibility criteria
- Patients undergoing TAVR
- Age between 18 and 95 years.
- Patient's agreement to participate in the protocol and to sign the informed consent form.
- Lack of informed consent
- Acute cerebrovascular conditions;
- Advanced heart failure.
- allergies to sedative medications used or to any of the excipients
- presence of preoperative delirium
- Patients with psychiatric disorders on pharmacological therapy;
- Participation in a clinical study where an experimental drug has been administered within 30 days of screening or within the 5 half-lives of the investigational drug (whichever period is longer)
- Women of potentially childbearing age (potentially childbearing age: any woman who has had her first menstruation until the post-menopausal period; postmenopausal woman: woman at least 45 years old who has not had menstrual periods for at least 12 months);
- Concomitant procedures other than TAVR (e.g., Percutaneous Coronary Intervention);
- Advanced 2nd or 3rd degree atrioventricular block in patients without a pacemaker;
- Uncontrolled hypotension
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.