Aortic StenosisNCT03084978
Conscious Sedation vs General Anesthesia in TAVR Patients
A study testing General Anesthesia and Conscious Sedation in people with Aortic Stenosis, run by Montefiore Medical Center.
Trial summary
This is a randomized controlled trial investigating the effect of general anesthesia versus conscious sedation on operative times in patients undergoing transcatheter aortic valve replacement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- General Anesthesia and Conscious Sedation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2017to Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent, signed Health Insurance Portability and Accountability Act (HIPAA) documentation)
- Age over 18 years of age.
- Women of child bearing age must have a negative urine or serum pregnancy test.
- Clinical indication for a transfemoral aortic valve replacement.
- English or Spanish speaking
- No evidence of neurological impairment as defined by a NIHSS ≤ 1 and modified Rankin scale (mRS) ≤ 2 within 7 days prior to randomization.
Who cannot join
- BMI > 40
- Diagnosis of severe obstructive sleep apnea based on previous polysomnography, with severe defined as an apnea-hypopnea index (AHI) >30 episodes/hr.
- High risk for aspiration such as severe esophageal disease (e.g. achalasia, gastroparesis, etc).
- Inability to lie supine for more than 30 minutes.
- Marginal femoral vessels with concern for possible conversion to transapical or transaortic access.
- Patient refusal
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- Patient involved in another research study
- Psychiatric condition precluding ability to provide informed consent
- History of clinical stroke within 3 months prior to randomization
About this study
Official title: Randomized Prospective Study in Transcatheter Aortic Valve Replacement Patients- Conscious Sedation VS. General Anesthesia Examining the Effect on Operative Time
This is a randomized controlled trial investigating the effect of general anesthesia versus conscious sedation on operative times in patients undergoing transcatheter aortic valve replacement.
- Conditions
- Aortic Stenosis
- Being tested
- General Anesthesia, Conscious Sedation
- 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.
General AnesthesiaProcedure or surgery
General anesthesia by standard endotracheal intubation.
Conscious SedationProcedure or surgery
Conscious sedation
| Study group | Role | What they receive |
|---|---|---|
| General Anesthesia | Active comparator | Subjects will undergo general anesthesia with endotracheal intubation. Receives: Procedure: General Anesthesia |
| Conscious Sedation | Experimental | Subjects will undergo conscious sedation anesthesia. Receives: Procedure: Conscious Sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-on-table
- time to patient on table to surgical drapes down
- time to patient on table to when deemed safe for transport by anesthesiologist and surgeon
Measured: <1 day
Secondary outcomes (6)
Number of patients with serious adverse events
- deaths
- conversion from sedation to intubation
- hypersensitivity reactions
Measured: within 30 days
Length of stay
- ICU length of stay (days)
- Hospital length of stay (days)
Measured: within 30 days
Readmissions
Number of patients readmitted within 30 days of initial procedure
Measured: within 30 days
Number of Patients with Valve Complications
- paravalvular leak on echocardiogram
- pacemaker requirement
- vascular complications requiring reintervention
- post-procedure requiring valve dilation
Measured: within 30 days
Contrast usage
Amount of contrast used in mL for procedure
Measured: <1 day
Fluoroscopy time
Amount of time fluoroscopy used
Measured: <1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study startApr 2017 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionApr 2019 (estimated)
Why it stopped: Study was never approved by the IRB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph DeRose, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03084978
- Sponsor's protocol ID
- 2016-7021
- Status last verified
- Jun 2019
- First submitted
- 25 Jan 2017
- Last updated
- 14 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brecker SJ, Bleiziffer S, Bosmans J, Gerckens U, Tamburino C, Wenaweser P, Linke A; ADVANCE Study Investigators. Impact of Anesthesia Type on Outcomes of Transcatheter Aortic Valve Implantation (from the Multicenter ADVANCE Study). Am J Cardiol. 2016 Apr 15;117(8):1332-8. doi: 10.1016/j.amjcard.2016.01.027. Epub 2016 Jan 28.
PubMed 26892451
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Prospective Study in Transcatheter Aortic Valve Replacement Patients- Conscious Sedation VS. General Anesthesia Examining the Effect on Operative Time
- ClinicalTrials.gov ID
- NCT03084978
- Acronym / sponsor ID
- 2016-7021
- Conditions
- Aortic Stenosis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was never approved by the IRB
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Apr 2017 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 21 Mar 2017 (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.
This is a randomized controlled trial investigating the effect of general anesthesia versus conscious sedation on operative times in patients undergoing transcatheter aortic valve replacement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia | Active comparator | Procedure: General AnesthesiaSubjects will undergo general anesthesia with endotracheal intubation. |
| Conscious Sedation | Experimental | Procedure: Conscious SedationSubjects will undergo conscious sedation anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent, signed Health Insurance Portability and Accountability Act (HIPAA) documentation)
- Age over 18 years of age.
- Women of child bearing age must have a negative urine or serum pregnancy test.
- Clinical indication for a transfemoral aortic valve replacement.
- English or Spanish speaking
Key exclusion criteria (9 listed)
- BMI > 40
- Diagnosis of severe obstructive sleep apnea based on previous polysomnography, with severe defined as an apnea-hypopnea index (AHI) >30 episodes/hr.
- High risk for aspiration such as severe esophageal disease (e.g. achalasia, gastroparesis, etc).
- Inability to lie supine for more than 30 minutes.
- Marginal femoral vessels with concern for possible conversion to transapical or transaortic access.
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 |
|---|---|---|
| General AnesthesiaGeneral anesthesia by standard endotracheal intubation. | Procedure or surgery | General Anesthesia |
| Conscious SedationConscious sedation | Procedure or surgery | Conscious Sedation |
Primary outcome
Time-on-table
Time frame: <1 day
* time to patient on table to surgical drapes down * time to patient on table to when deemed safe for transport by anesthesiologist and surgeon
6 secondary outcomes
Number of patients with serious adverse events
Time frame: within 30 days
Length of stay
Time frame: within 30 days
Readmissions
Time frame: within 30 days
Number of Patients with Valve Complications
Time frame: within 30 days
Contrast usage
Time frame: <1 day
Fluoroscopy time
Time frame: <1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
- Background: PubMed 26892451Brecker SJ, Bleiziffer S, Bosmans J, Gerckens U, Tamburino C, Wenaweser P, Linke A; ADVANCE Study Investigators. Impact of Anesthesia Type on Outcomes of Transcatheter Aortic Valve Implantation (from the Multicenter ADVANCE Study). Am J Cardiol. 2016 Apr 15;117(8):1332-8. doi: 10.1016/j.amjcard.2016.01.027. Epub 2016 Jan 28.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Joseph DeRose, MD principal investigator
Montefiore Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing General Anesthesia and Conscious Sedation in people with Aortic Stenosis, run by Montefiore Medical Center.
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 6 inclusion and 9 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: withdrawn, as of the sponsor's last update on 14 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-on-table (time frame: <1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03084978, which also lists 1 linked publication.
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 14 Jun 2019.