Transcatheter Aortic Valve Replacement (TAVR)Phase 4NCT07556523
Patient Quality of Recovery After TAVR With Different Sedation Regimens
A Phase 4 study testing Propofol, Dexmedetomidine and Midazolam in people with Transcatheter Aortic Valve Replacement (TAVR) and Aortic Valve Stenosis, run by David Lyubashevsky at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn whether the type of sedation medication used during a transcatheter aortic valve replacement (TAVR) affects how people recover after the procedure. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Transcatheter Aortic Valve Replacement (TAVR), Aortic Valve Stenosis
- What is being tested?
- Propofol, Dexmedetomidine and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2026to Jun 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-90 years old, inclusive
- Undergoing transfemoral TAVR under Monitored Anesthesia Care (MAC)
- Speaks English or Spanish
- Consents to participate
Who cannot join
- Preoperative heart rate < 50 bpm or arrhythmias (e.g., AFib with RVR)
- Conduction abnormalities (e.g., 2nd/3rd degree AV block without pacer)
- Allergy or contraindication to study drugs
- Pulmonary artery pressure > 70mmHg
- Morbid obesity BMI > 50
- Pregnancy
- Unable to consent in English or Spanish
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Endeavor Health
Glenview, Illinois, 60026
Jessica Brickner, 847-570-1197, jessica.brickner@endeavorhealth.org
David Lyubashevsky, MD
About this study
The goal of this clinical trial is to learn whether the type of sedation medication used during a transcatheter aortic valve replacement (TAVR) affects how people recover after the procedure. The main question this study aims to answer is whether different sedation regimens (propofol, dexmedetomidine, or midazolam with fentanyl) lead to differences in quality of recovery on the first day after the procedure.
Researchers will compare three commonly used sedation medications (propofol, dexmedetomidine, or midazolam with fentanyl) to determine whether they lead to differences in recovery following a TAVR.
Read more
Participants will:
- Be enrolled before their scheduled TAVR procedure
- Be randomly assigned to receive one of the three sedation medications during their procedure
- Complete short surveys on postoperative days 1 and 7 about pain levels, how they feel during their recovery, and how satisfied they were with their anesthesia experience
- Being tested
- Propofol, Dexmedetomidine, Midazolam, Fentanyl
- Keywords
- Transcatheter aortic valve replacement, TAVR, Sedation strategy, Anesthesia
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Propofol will be administered intravenously for intraoperative sedation during transcatheter aortic valve replacement (TAVR), with initiation and maintenance infusion dosing of 5-100 mcg/kg/min, titrated to clinical effect according to standard anesthesia practice.
DexmedetomidineDrug
Dexmedetomidine will be administered intravenously for intraoperative sedation during transcatheter aortic valve replacement (TAVR), with initiation and maintenance infusion dosing of 0.2-1.0 mcg/kg/hr, titrated to clinical effect according to standard anesthesia practice.
MidazolamDrug
Midazolam will be administered intravenously for intraoperative sedation during TAVR and titrated to achieve adequate sedation and analgesia according to standard anesthesia practice.
FentanylDrug
Fentanyl will be administered intravenously for intraoperative sedation during TAVR and titrated to achieve adequate sedation and analgesia according to standard anesthesia practice.
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Experimental | Participants will receive propofol for intraoperative sedation during transcatheter aortic valve replacement (TAVR). Receives: Drug: Propofol |
| Dexmedetomidine | Experimental | Participants will receive dexmedetomidine for intraoperative sedation during transcatheter aortic valve replacement (TAVR). Receives: Drug: Dexmedetomidine |
| Midazolam and Fentanyl | Experimental | Participants will receive a combination of midazolam and fentanyl for intraoperative sedation during transcatheter aortic valve replacement (TAVR). Receives: Drug: Midazolam; Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery on Postoperative Day 1 Measured by QoR-15 Survey
The primary outcome of the study will be the quality of recovery, as measured by the Quality of Recovery-15 (QoR-15) score. A baseline QoR-15 survey will be taken before or on the day of the procedure, and the resulting aggregate score will be compared to the score from the QoR-15 survey completed on post-operative day 1 (POD 1).
The QoR-15 survey is 15-item questionnaire which has a scale of 0-10 pertaining to a patient's comfort, support system, pain, well-being, and ability to carry out daily activities. For questions 1-10, number "0" indicates none of the time and number "10" indicates all of the time. For questions 11-15, number "0" indicates all of the time and number "10" indicates none of the time. A higher overall score indicates a better outcome (i.e. better quality of recovery) and a lower score indicates a worse outcome (i.e. poorer quality of recovery).
Measured: From baseline assessment prior to transcatheter aortic valve replacement (TAVR) through postoperative day 1
Secondary outcomes (14)
Heart Rate Change
Change in heart rate from baseline to nadir intraoperatively and at Post-Anesthesia Care Unit (PACU) admission.
Measured: Intraoperative period through PACU admission
Length of Stay
PACU length of stay and total hospital length of stay
Measured: From date of procedure through hospital discharge (up to 30 days after procedure date, whichever comes first)
Patient Satisfaction with Anesthesia Measured by 5-Point Likert Scale
Patient-reported satisfaction with anesthesia measured using a 5-point Likert scale. Patients will respond to this statement: The anesthesia care I received during my transcatheter aortic valve replacement (TAVR) procedure met my expectations (5 = Strongly Agree; 1 = Strongly Disagree).
Measured: Postoperative day 1 and postoperative day 7
Pain Scores Measured by Visual Analog Scale (VAS)
Pain severity measured using the Visual Analog Scale (VAS).
Measured: Upon post-anesthesia care unit (PACU) arrival (within ~2 hours after procedure), upon PACU discharge (~4 hours after procedure/medically cleared to leave PACU), on postoperative day 1, and postoperative day 7
Quality of Recovery on Postoperative Day 7 Measured by QoR-15 Survey
Quality of recovery measured using the Quality of Recover-15 (QoR-15) questionnaire on postoperative day 7. The QoR-15 survey is 15-item questionnaire which has a scale of 0-10 pertaining to a patient's comfort, support system, pain, well-being, and ability to carry out daily activities. For questions 1-10, number "0" indicates none of the time and number "10" indicates all of the time. For questions 11-15, number "0" indicates all of the time and number "10" indicates none of the time. A higher overall score indicates a better outcome (i.e. better quality of recovery) and a lower score indicates a worse outcome (i.e. poorer quality of recovery).
Measured: Postoperative day 7
Cardiologist Operating Conditions Rating
Cardiologist-rated procedural conditions assessed using a 5-point Likert scale. The cardiologist will report their satisfaction with the TAVR patient's surgical condition (5 = Very Satisfied; 1 = Very Dissatisfied)
Measured: Immediately after completion of the TAVR procedure (intraoperative period)
30-Day Readmission Rates
Hospital readmission rates within 30 days following TAVR
Measured: Within 30 days post-hospital discharge.
Incidence of Hypotension Requiring Medical Intervention
Incidence of hypotension (defined as ≥20% reduction from baseline) requiring medical intervention.
Measured: Intraoperative period
Fluid Administration From Start of Procedure Through PACU Discharge
Total intravenous fluid volume administered.
Measured: From procedure start through post-anesthesia care unit discharge (~4 hours after procedure/medically cleared to leave PACU)
Incidence of Intraoperative Bradycardia
Incidence of heart rate < 60 beats per minute.
Measured: Intraoperative period
Surgical Bleeding
Incidence of clinically significant surgical bleeding.
Measured: Intraoperative period
Conversion to General Anesthesia
Need for conversion from planned sedation to general anesthesia.
Measured: Intraoperative period
Postoperative Pacemaker Placement
Need for new permanent pacemaker implantation after TAVR.
Measured: During postoperative period (within 30 days)
Postoperative Delirium Measured by 4AT Assessment
Incidence of postoperative delirium assessed using the 4AT screening tool.
Measured: Preoperative baseline, upon PACU discharge (~4 hours after procedure/medically cleared to leave PACU), and 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start16 Mar 2026
- Primary completionApr 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcatheter Aortic Valve Replacement (TAVR)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to one of three anesthetic regimen cohorts in a 1:1:1 ratio: dexmedetomidine (with option for midazolam/fentanyl) or propofol infusion (with option for midazolam and fentanyl) or midazolam/fentanyl alone.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Lyubashevsky
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David Lyubashevsky, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556523
- Sponsor's protocol ID
- IRB2025-0154
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional policies and to protect participant privacy.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Quality of Recovery After TAVR With Different Sedation Regimens
- ClinicalTrials.gov ID
- NCT07556523
- Acronym / sponsor ID
- IRB2025-0154
- Keywords
- Transcatheter aortic valve replacement, TAVR, Sedation strategy, Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- David LyubashevskyUniversity, hospital or other
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn whether the type of sedation medication used during a transcatheter aortic valve replacement (TAVR) affects how people recover after the procedure. The main question this study aims to answer is whether different sedation regimens (propofol, dexmedetomidine, or midazolam with fentanyl) lead to differences in quality of recovery on the first day after the procedure.
Researchers will compare three commonly used sedation medications (propofol, dexmedetomidine, or midazolam with fentanyl) to determine whether they lead to differences in recovery following a TAVR.
Participants will:
- Be enrolled before their scheduled TAVR procedure
- Be randomly assigned to receive one of the three sedation medications during their procedure
- Complete short surveys on postoperative days 1 and 7 about pain levels, how they feel during their recovery, and how satisfied they were with their anesthesia experience
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Participants will be randomized to one of three anesthetic regimen cohorts in a 1:1:1 ratio: dexmedetomidine (with option for midazolam/fentanyl) or propofol infusion (with option for midazolam and fentanyl) or midazolam/fentanyl alone.
| Arm | Type | Receives |
|---|---|---|
| Propofol | Experimental | Drug: PropofolParticipants will receive propofol for intraoperative sedation during transcatheter aortic valve replacement (TAVR). |
| Dexmedetomidine | Experimental | Drug: DexmedetomidineParticipants will receive dexmedetomidine for intraoperative sedation during transcatheter aortic valve replacement (TAVR). |
| Midazolam and Fentanyl | Experimental | Drug: Midazolam, Drug: FentanylParticipants will receive a combination of midazolam and fentanyl for intraoperative sedation during transcatheter aortic valve replacement (TAVR). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-90 years old, inclusive
- Undergoing transfemoral TAVR under Monitored Anesthesia Care (MAC)
- Speaks English or Spanish
- Consents to participate
Key exclusion criteria (7 listed)
- Preoperative heart rate < 50 bpm or arrhythmias (e.g., AFib with RVR)
- Conduction abnormalities (e.g., 2nd/3rd degree AV block without pacer)
- Allergy or contraindication to study drugs
- Pulmonary artery pressure > 70mmHg
- Morbid obesity BMI > 50
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolPropofol will be administered intravenously for intraoperative sedation during transcatheter aortic valve replacement (TAVR), with initiation and maintenance infusion dosing of 5-100 mcg/kg/min, titrated to clinical effect according to standard anesthesia practice. | Drug | Propofol |
| DexmedetomidineDexmedetomidine will be administered intravenously for intraoperative sedation during transcatheter aortic valve replacement (TAVR), with initiation and maintenance infusion dosing of 0.2-1.0 mcg/kg/hr, titrated to clinical effect according to standard anesthesia practice. | Drug | Dexmedetomidine |
| MidazolamMidazolam will be administered intravenously for intraoperative sedation during TAVR and titrated to achieve adequate sedation and analgesia according to standard anesthesia practice. | Drug | Midazolam and Fentanyl |
| FentanylFentanyl will be administered intravenously for intraoperative sedation during TAVR and titrated to achieve adequate sedation and analgesia according to standard anesthesia practice. | Drug | Midazolam and Fentanyl |
Primary outcome
Quality of Recovery on Postoperative Day 1 Measured by QoR-15 Survey
Time frame: From baseline assessment prior to transcatheter aortic valve replacement (TAVR) through postoperative day 1
The primary outcome of the study will be the quality of recovery, as measured by the Quality of Recovery-15 (QoR-15) score. A baseline QoR-15 survey will be taken before or on the day of the procedure, and the resulting aggregate score will be compared to the score from the QoR-15 survey completed on post-operative day 1 (POD 1). The QoR-15 survey is 15-item questionnaire which has a scale of 0-10 pertaining to a patient's comfort, support system, pain, well-being, and ability to carry out daily activities. For questions 1-10, number "0" indicates none of the time and number "10" indicates all of the time. For questions 11-15, number "0" indicates all of the time and number "10" indicates none of the time. A higher overall score indicates a better outcome (i.e. better quality of recovery) and a lower score indicates a worse outcome (i.e. poorer quality of recovery).
14 secondary outcomes
Heart Rate Change
Time frame: Intraoperative period through PACU admission
Length of Stay
Time frame: From date of procedure through hospital discharge (up to 30 days after procedure date, whichever comes first)
Patient Satisfaction with Anesthesia Measured by 5-Point Likert Scale
Time frame: Postoperative day 1 and postoperative day 7
Pain Scores Measured by Visual Analog Scale (VAS)
Time frame: Upon post-anesthesia care unit (PACU) arrival (within ~2 hours after procedure), upon PACU discharge (~4 hours after procedure/medically cleared to leave PACU), on postoperative day 1, and postoperative day 7
Quality of Recovery on Postoperative Day 7 Measured by QoR-15 Survey
Time frame: Postoperative day 7
Cardiologist Operating Conditions Rating
Time frame: Immediately after completion of the TAVR procedure (intraoperative period)
30-Day Readmission Rates
Time frame: Within 30 days post-hospital discharge.
Incidence of Hypotension Requiring Medical Intervention
Time frame: Intraoperative period
Fluid Administration From Start of Procedure Through PACU Discharge
Time frame: From procedure start through post-anesthesia care unit discharge (~4 hours after procedure/medically cleared to leave PACU)
Incidence of Intraoperative Bradycardia
Time frame: Intraoperative period
Surgical Bleeding
Time frame: Intraoperative period
Conversion to General Anesthesia
Time frame: Intraoperative period
Postoperative Pacemaker Placement
Time frame: During postoperative period (within 30 days)
Postoperative Delirium Measured by 4AT Assessment
Time frame: Preoperative baseline, upon PACU discharge (~4 hours after procedure/medically cleared to leave PACU), and 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional policies and to protect participant privacy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol, Dexmedetomidine and Midazolam in people with Transcatheter Aortic Valve Replacement (TAVR) and Aortic Valve Stenosis, run by David Lyubashevsky at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Brickner (847-570-1197, jessica.brickner@endeavorhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovery on Postoperative Day 1 Measured by QoR-15 Survey (time frame: From baseline assessment prior to transcatheter aortic valve replacement (TAVR) through postoperative day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.