Prospective comparative randomized study of procedural sedation during TAVR (Transcatheter Aortic Valve Replacement)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Azienda Socio Sanitaria Territoriale Ovest Milanese

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Health Care [N] - Health Care Quality, Access, and Evaluation [N05], Diseases [C] - Cardiovascular Diseases [C14], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Trial duration

9 Aug 2024 → ongoing

Decision date (initial)

2024-07-01

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy

- 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.

Secondary objectives 2

1. Assessment of sedation effectiveness.
2. - Evaluation of the incidence of adverse events during and after the procedure

Conditions and MedDRA coding

patients with aortic stenosis underwent transcatheter aortic valve replacement

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Patients undergoing TAVR
2. Age between 18 and 95 years.
3. Patient's agreement to participate in the protocol and to sign the informed consent form.

Exclusion criteria 11

1. Lack of informed consent
2. allergies to sedative medications used or to any of the excipients
3. presence of preoperative delirium
4. Patients with psychiatric disorders on pharmacological therapy;
5. 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)
6. 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);
7. Concomitant procedures other than TAVR (e.g., Percutaneous Coronary Intervention);
8. Advanced 2nd or 3rd degree atrioventricular block in patients without a pacemaker;
9. Uncontrolled hypotension
10. Acute cerebrovascular conditions;
11. Advanced heart failure.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Incidence of respiratory acidosis: Defined as pH<7.35 and an increase in PaCO2 compared to baseline, measured through serial arterial blood gas analysis during the procedure.
2. Incidence of emergence delirium: Assessed through the administration of the CAM-ICU (Confusion Assessment Method for the Intensive Care Unit) within the first 24 hours following the end of the procedure.

Secondary endpoints 3

1. The assessment of sedation effectiveness includes: - Time to achieve the desired sedation target (from the start of sedation to reaching a Richmond Agitation Sedation Scale of -2/-3). - Time to meet discharge criteria from the operating room (from sedation cessation to achieving an Aldrete's scoring system score >9). - Incidence of agitation episodes (RASS > +1). - Intraprocedural need to deviate from the established protocol beyond the therapeutic ranges indicated.
2. The assessment of the incidence of intra-procedural adverse events includes: - Incidence of respiratory events (desaturation, need for supplemental oxygen, loss of respiratory drive, need for mask ventilation, respiratory acidosis with pH<7.35 and an increase in PaCO2 compared to baseline). - Incidence of hemodynamic events (hypotension, bradycardia, need for vasopressor support).
3. The evaluation of post-operative adverse events includes: - Total duration of hospitalization. - Incidence of post-operative cognitive decline (changes in Mini Mental State postoperative compared to baseline).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Comparator 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Azienda Socio Sanitaria Territoriale Ovest Milanese

Sponsor organisation

Azienda Socio Sanitaria Territoriale Ovest Milanese

Address

Via Papa Giovanni Paolo II

City

Legnano

Postcode

20025

Country

Italy

Scientific contact point

Organisation

Azienda Socio Sanitaria Territoriale Ovest Milanese

Contact name

Matteo Lucchelli

Public contact point

Organisation

Azienda Socio Sanitaria Territoriale Ovest Milanese

Contact name

Liana Bevilacqua

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications