Conscious Sedation vs General Anesthesia in TAVR Patients

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POLESTAR Trial – An International Multi-center Early Discharge TAVI Program REPRISE EDGE 29 mm EU Study The CONFIDENCE Registry Interest of Cardiac Computed Tomography to Optimize and Improve the Procedure of TAVI Transapical Implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System – The Engager European Pivotal Trial Post-Market Follow-up of the CENTERA Transcatheter Heart Valve System SecOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in TAVI Balloon Aortic Valvuloplasty During Surgical Aortic Valve Replacement The PROTEMBO SF Trial Adjuvant Radiation in Aortic Valvuloplasty – ARAVA Value of Oral Phytate (InsP6) in the Prevention of Progression of the Cardiovascular Calcifications Supra-Annular vs. Annular ValvEs for Small Annuli Heart Leaflet Technologies Valve Study A Study to Evaluate the Neuro-embolic Consequences of TAVR Femoral vs Radial Approach and MRI Evaluation of Strokes Mortality Post-TAVI and Correlation With Haemodynamic Parameters. 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Insertable Cardiac Monitoring Device Reactive Oxygen Species Following Aortic Valve Replacement Biological Factors Associated With Subclinical Valvular Thrombosis Hemodynamic Comparison of Tissue Aortic Valves Volume Challenge Added to DSE in the Diagnosis of Severe LFLGAS Impact of Perioperative Treatment With Intravenous Glutamine on Myocardial Protection in Cardiac Surgery Patients With Aortic Stenosis The Effects of High Spinal Anesthesia on Heart Function, Stress Response and Pain Control in Aortic Valve Surgery A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan) Erythropoietin + Iron Therapy for Anemic Patients Undergoing Aortic Valve Replacement A Study Evaluating the Effects of Ataciguat (HMR1766) on Aortic Valve Calcification Efficacy of Angiotensin Receptor Blocker Following aortIc Valve Intervention for Aortic STenOsis: a Randomized mulTi-cEntric Double-blind Phase II Study Prehabilitation to Improve Functional and Clinical Outcomes in Patients With 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Evaluated Via Modern Ballistocardiography and Seismocardiography Study of Platelet Activation by Severe Aortic Stenosis and Its Correction by Transcatheter Aortic Valve Implantation Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve The Plasma Serotonin and Aortic Stenosis: a Pilot Study. 18F-NaF Uptake and Aortic Stenosis Progression Cardiovascular Rehabilitation in Patients With Severe Aortic Stenosis Submitted to Valvar Correction Aortic Stenosis and PhosphodiEsterase Type 5 iNhibition (ASPEN): A Pilot Study Clinical Outcome of Patients With Low-gradient Severe Aortic Stenosis Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis Fetal Intervention for Aortic Stenosis and Evolving Hypoplastic Left Heart Syndrome The PARTNER 3 – Trial – The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis Ventricular Remodeling In Patients With Aortic Stenosis Assessed 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Brief Title

Conscious Sedation vs General Anesthesia in TAVR Patients

Official Title

Randomized Prospective Study in Transcatheter Aortic Valve Replacement Patients- Conscious Sedation VS. General Anesthesia Examining the Effect on Operative Time

Brief 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.

Study Type

Interventional

Primary Outcome

Time-on-table

Secondary Outcome

 Number of patients with serious adverse events

Condition

Aortic Stenosis

Intervention

General Anesthesia

Study Arms / Comparison Groups

 General Anesthesia
Description:  Subjects will undergo general anesthesia with endotracheal intubation.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

0

Start Date

April 2017

Completion Date

April 2019

Primary Completion Date

April 2019

Eligibility Criteria

        Inclusion Criteria:

          1. Signed informed consent, signed Health Insurance Portability and Accountability Act
             (HIPAA) documentation)

          2. Age over 18 years of age.

          3. Women of child bearing age must have a negative urine or serum pregnancy test.

          4. Clinical indication for a transfemoral aortic valve replacement.

          5. English or Spanish speaking

          6. No evidence of neurological impairment as defined by a NIHSS ≤ 1 and modified Rankin
             scale (mRS) ≤ 2 within 7 days prior to randomization.

        Exclusion Criteria:

          1. BMI > 40

          2. Diagnosis of severe obstructive sleep apnea based on previous polysomnography, with
             severe defined as an apnea-hypopnea index (AHI) >30 episodes/hr.

          3. High risk for aspiration such as severe esophageal disease (e.g. achalasia,
             gastroparesis, etc).

          4. Inability to lie supine for more than 30 minutes.

          5. Marginal femoral vessels with concern for possible conversion to transapical or
             transaortic access.

          6. Patient refusal

          7. Patient involved in another research study

          8. Psychiatric condition precluding ability to provide informed consent

          9. History of clinical stroke within 3 months prior to randomization

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Joseph DeRose, MD, ,

Administrative Informations

NCT ID

NCT03084978

Organization ID

2016-7021

Responsible Party

Sponsor

Study Sponsor

Montefiore Medical Center

Study Sponsor

Joseph DeRose, MD, Principal Investigator, Montefiore Medical Center

Verification Date

June 2019