Feasibility of Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic, Severe Aortic Stenosis

NCT02628899 | Completed DMC FDA Device

• 1 other identifier: Low Risk TAVR
• Study Type: interventional
• Target: 277
• Locations: 1 country
• Sites: 11

Brief Summary

To assess the safety and feasibility of Transcatheter Aortic Valve Replacement (TAVR) with commercially available bioprostheses in patients with severe, symptomatic aortic stenosis (AS) who are low-risk (STS score ≤3%) for surgical aortic valve replacement (SAVR).

Conditions

Aortic Stenosis

Outcome Measures

Primary Outcomes (7)

• All-cause mortality at 30 days following transfemoral TACR vs. bioprosthetic SAVR

  All-cause mortality at 30 days following transfemoral TACR vs. bioprosthetic SAVR

  30 days following transfemoral TAVR vs. bioprosthetic SAVR

• Composite of major adverse events at 30 days

  Composite of major adverse events at 30 days 1. all-cause mortality 2. stroke 3. spontaneous myocardial infarction (MI) 4. reintervention: defined as any cardiac surgery or percutaneous reintervention that repairs, alters, or replaces a previously implanted aortic valve 5. VARC life-threatening bleeding 6. Increase in serum creatinine to ≥300% (\>3x increase compared to baseline) OR serum creatinine ≥4.0 mg/dL with an acute increase ≥0.5 mg/dL OR new requirement for dialysis 7. coronary artery obstruction requiring percutaneous or surgical intervention 8. VARC major vascular complication 9. cardiac tamponade 10. cardiac perforation 11. pericarditis 12. mediastinitis 13. hemolysis 14. infective endocarditis 15. moderate or severe aortic insufficiency 16. significant aortic stenosis 17. permanent pacemaker implantation

  30 days

• All Cause Mortality

  30 days

• All Stroke (disabling and non-disabling, ischemic and hemorrhagic

  30 Days

• Life Threatening and Major Bleeding

  30 days

• Major Vascular Complications

  30 days

• Hospitalizations for valve-related symptoms or worsening congestive heart failure

  30 days

Secondary Outcomes (2)

• composite of all-cause mortality, stroke, spontaneous MI, re-intervention

  30 days, 6 months, 12 months, and 2,3,4 and 5 years

• VARC - 2 Device Success

  30 days

Study Arms (3)

Prospective TAVR Arm

OTHER

200 patients prospectively undergoing transfemoral TAVR

Device: Transfemoral TAVR

Historical SAVR Controls

OTHER

Historical controls will be selected from among patients at the same site who have undergone isolated bioprosthetic SAVR within the previous 36 months. TAVR patients will then be matched to SAVR patients using STS database variables to perform propensity matching, including (but not limited to) age, gender, race, ethnicity, STS score, and valve prosthesis size.

Device: SAVR

Low-Risk TAVR with Bicuspid Aortic Valve

OTHER

The third arm of the trial will comprise a registry of TAVR in up to 100 low-risk patients with bicuspid aortic valve. The results from the registry arm will be analyzed independently.

Device: Transfemoral TAVR

Interventions

Transfemoral TAVR DEVICE

Also known as: Transcatheter aortic valve replacement

Low-Risk TAVR with Bicuspid Aortic Valve; Prospective TAVR Arm

SAVR DEVICE

Also known as: Surgical Aortic Valve Replacement

Historical SAVR Controls

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe, degenerative AS, defined as:
• mean aortic valve gradient ≥40 mm Hg OR Vmax ≥4 m/sec AND
• calculated aortic valve area ≤1.0 cm2 OR aortic valve area index ≤0.6 cm2/m2
• Symptomatic AS, defined as a history of at least one of the following:
• dyspnea that qualifies at New York Heart Association (NYHA) class II or greater
• angina pectoris
• cardiac syncope
• The Heart Team, including at least one cardiothoracic surgeon and one interventional cardiologist, deem the patient to be reasonable for transfemoral TAVR with a commercially available bioprosthetic valve
• The Heart Team agrees that the patient is low-risk, quantified by an estimated risk of ≤3% by the calculated STS score for operative mortality at 30 days; AND agrees that SAVR would be an appropriate therapy if offered.
• The Heart Team agrees that transfemoral TAVR is anatomically feasible, based upon multislice CT measurements
• Procedure status is elective
• Expected survival is at least 24 months
• For the bicuspid cohort only:
• Aortic Stenosis of a bicuspid aortic valve

You may not qualify if:

• Concomitant disease of another heart valve or the aorta that requires either transcatheter or surgical intervention
• Any condition that is considered a contraindication for placement of a bioprosthetic aortic valve (e.g. patient requires a mechanical aortic valve)
• Aortic stenosis secondary to a bicuspid aortic valve (except for the bicuspid valve cohort)
• Prior bioprosthetic surgical aortic valve replacement
• Mechanical heart valve in another position
• End-stage renal disease requiring hemodialysis or peritoneal dialysis, or a creatinine clearance \<20 cc/min
• Left ventricular ejection fraction \<20%
• Recent (\<6 months) history of stroke or transient ischemic attack
• Symptomatic carotid or vertebral artery disease, or recent (\<6 weeks) surgical or endovascular treatment of carotid stenosis
• Any contraindication to oral antiplatelet or anticoagulation therapy following the procedure, including recent or ongoing bleeding, or HASBLED score \>3
• Severe coronary artery disease that is unrevascularized
• Recent (\<30 days) acute myocardial infarction
• Patient cannot undergo transfemoral TAVR for anatomic reasons (as determined by supplemental imaging studies); this would include inadequate size of iliofemoral access vessels or an aortic annulus size that is not accommodated by the commercially available valves
• Any comorbidity not captured by the STS score that would make SAVR high risk, as determined by a cardiothoracic surgeon who is a member of the heart team; this includes:
• porcelain or severely atherosclerotic aorta

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (11)

Sutter Health System

Sacramento, California, 95816, United States

Location

Foundation for Cardiovascular Medicine

San Diego, California, 92121, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

WellStar Kennestone Hospital

Marietta, Georgia, 30060, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

The Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

Stony Brook Hospital

Stony Brook, New York, 11794, United States

Location

St. John Health System

Tulsa, Oklahoma, 74104, United States

Location

Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Henrico Doctors' Hospital

Richmond, Virginia, 23229, United States

Location

VCU Medical Center

Richmond, Virginia, 23298, United States

Location

Related Publications (13)

• Waksman R, Rogers T, Torguson R, Gordon P, Ehsan A, Wilson SR, Goncalves J, Levitt R, Hahn C, Parikh P, Bilfinger T, Butzel D, Buchanan S, Hanna N, Garrett R, Asch F, Weissman G, Ben-Dor I, Shults C, Bastian R, Craig PE, Garcia-Garcia HM, Kolm P, Zou Q, Satler LF, Corso PJ. Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic Severe Aortic Stenosis. J Am Coll Cardiol. 2018 Oct 30;72(18):2095-2105. doi: 10.1016/j.jacc.2018.08.1033. Epub 2018 Aug 28.

  PMID: 30170075 BACKGROUND

• Waksman R, Corso PJ, Torguson R, Gordon P, Ehsan A, Wilson SR, Goncalves J, Levitt R, Hahn C, Parikh P, Bilfinger T, Butzel D, Buchanan S, Hanna N, Garrett R, Buchbinder M, Asch F, Weissman G, Ben-Dor I, Shults C, Bastian R, Craig PE, Ali S, Garcia-Garcia HM, Kolm P, Zou Q, Satler LF, Rogers T. TAVR in Low-Risk Patients: 1-Year Results From the LRT Trial. JACC Cardiovasc Interv. 2019 May 27;12(10):901-907. doi: 10.1016/j.jcin.2019.03.002. Epub 2019 Mar 12.

  PMID: 30860059 BACKGROUND

• Khan JM, Rogers T, Waksman R, Torguson R, Weissman G, Medvedofsky D, Craig PE, Zhang C, Gordon P, Ehsan A, Wilson SR, Goncalves J, Levitt R, Hahn C, Parikh P, Bilfinger T, Butzel D, Buchanan S, Hanna N, Garrett R, Shults C, Garcia-Garcia HM, Kolm P, Satler LF, Buchbinder M, Ben-Dor I, Asch FM. Hemodynamics and Subclinical Leaflet Thrombosis in Low-Risk Patients Undergoing Transcatheter Aortic Valve Replacement. Circ Cardiovasc Imaging. 2019 Dec;12(12):e009608. doi: 10.1161/CIRCIMAGING.119.009608. Epub 2019 Dec 12.

  PMID: 31826675 BACKGROUND

• Rogers T, Torguson R, Bastian R, Corso P, Waksman R. Feasibility of transcatheter aortic valve replacement in low-risk patients with symptomatic severe aortic stenosis: Rationale and design of the Low Risk TAVR (LRT) study. Am Heart J. 2017 Jul;189:103-109. doi: 10.1016/j.ahj.2017.03.008. Epub 2017 Mar 14.

  PMID: 28625366 BACKGROUND

• Reddy P, Rodriguez-Weisson FJ, Medranda GA, Merdler I, Cellamare M, Gordon P, Ehsan A, Parikh P, Bilfinger T, Buchbinder M, Roberts D, Hanna N, Ben-Dor I, Satler LF, Garcia-Garcia HM, Asch FM, Weissman G, Sadeghpour A, Schults CC, Waksman R, Rogers T. Impact of Calcified Raphe on TAVR in Bicuspid Patients: Predicting Redo-TAVR Feasibility and Virtual Planning Implications. Circ Cardiovasc Interv. 2025 Jun;18(6):e014802. doi: 10.1161/CIRCINTERVENTIONS.124.014802. Epub 2025 Apr 22.

  PMID: 40260550 DERIVED

• Bhogal S, Waksman R, Shea C, Zhang C, Gordon P, Ehsan A, Wilson SR, Levitt R, Parikh P, Bilfinger T, Hanna N, Buchbinder M, Asch FM, Weissman G, Ben-Dor I, Shults CC, Ali S, Garcia-Garcia HM, Satler LF, Rogers T. Self-expanding and balloon-expandable valves in low risk TAVR patients. Int J Cardiol. 2024 Jan 15;395:131431. doi: 10.1016/j.ijcard.2023.131431. Epub 2023 Oct 12.

  PMID: 37832606 DERIVED

• Waksman R, Bhogal S, Gordon P, Ehsan A, Wilson SR, Levitt R, Parikh P, Bilfinger T, Hanna N, Buchbinder M, Asch FM, Kim FY, Weissman G, Ben-Dor I, Shults CC, Ali S, Sutton JA, Shea C, Zhang C, Garcia-Garcia HM, Satler LF, Rogers T. Transcatheter Aortic Valve Replacement and Impact of Subclinical Leaflet Thrombosis in Low-Risk Patients: LRT Trial 4-Year Outcomes. Circ Cardiovasc Interv. 2023 May;16(5):e012655. doi: 10.1161/CIRCINTERVENTIONS.122.012655. Epub 2023 May 16.

  PMID: 37192308 DERIVED

• Medranda GA, Soria Jimenez CE, Torguson R, Case BC, Forrestal BJ, Ali SW, Shea C, Zhang C, Wang JC, Gordon P, Ehsan A, Wilson SR, Levitt R, Parikh P, Bilfinger T, Hanna N, Buchbinder M, Asch FM, Weissman G, Shults CC, Garcia-Garcia HM, Ben-Dor I, Satler LF, Waksman R, Rogers T. Lifetime management of patients with symptomatic severe aortic stenosis: a computed tomography simulation study. EuroIntervention. 2022 Aug 5;18(5):e407-e416. doi: 10.4244/EIJ-D-21-01091.

  PMID: 35321859 DERIVED

• Medranda GA, Rogers T, Forrestal BJ, Case BC, Yerasi C, Chezar-Azerrad C, Shults CC, Torguson R, Shea C, Parikh P, Bilfinger T, Cocke T, Brizzio ME, Levitt R, Hahn C, Hanna N, Comas G, Mahoney P, Newton J, Buchbinder M, Zhang C, Craig PE, Weigold WG, Asch FM, Weissman G, Garcia-Garcia HM, Ben-Dor I, Satler LF, Waksman R. Balloon-Expandable Valve Geometry After Transcatheter Aortic Valve Replacement in Low-Risk Patients With Bicuspid Versus Tricuspid Aortic Stenosis. Cardiovasc Revasc Med. 2021 Dec;33:7-12. doi: 10.1016/j.carrev.2021.03.027. Epub 2021 Apr 6.

  PMID: 34078581 DERIVED

• Waksman R, Torguson R, Medranda GA, Shea C, Zhang C, Gordon P, Ehsan A, Wilson SR, Levitt R, Hahn C, Parikh P, Bilfinger T, Butzel D, Buchanan S, Hanna N, Buchbinder M, Asch F, Weissman G, Ben-Dor I, Shults C, Garcia-Garcia HM, Satler LF, Rogers T. Transcatheter aortic valve replacement in low-risk patients: 2-year results from the LRT trial. Am Heart J. 2021 Jul;237:25-33. doi: 10.1016/j.ahj.2021.03.006. Epub 2021 Mar 10.

  PMID: 33713618 DERIVED

• Khan JM, Rogers T, Weissman G, Torguson R, Rodriguez-Weisson FJ, Chezar-Azerrad C, Greenspun B, Gupta N, Medvedofsky D, Zhang C, Gordon P, Ehsan A, Wilson SR, Goncalves J, Levitt R, Hahn C, Parikh P, Bilfinger T, Butzel D, Buchanan S, Hanna N, Garrett R, Shults C, Buchbinder M, Garcia-Garcia HM, Kolm P, Satler LF, Hashim H, Ben-Dor I, Asch FM, Waksman R. Anatomical Characteristics Associated With Hypoattenuated Leaflet Thickening in Low-Risk Patients Undergoing Transcatheter Aortic Valve Replacement. Cardiovasc Revasc Med. 2021 Jun;27:1-6. doi: 10.1016/j.carrev.2020.09.034. Epub 2020 Sep 25.

  PMID: 33129688 DERIVED

• Waksman R, Craig PE, Torguson R, Asch FM, Weissman G, Ruiz D, Gordon P, Ehsan A, Parikh P, Bilfinger T, Levitt R, Hahn C, Roberts D, Ingram M, Hanna N, Comas G, Zhang C, Ben-Dor I, Satler LF, Garcia-Garcia HM, Shults C, Rogers T. Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic Severe Bicuspid Aortic Valve Stenosis. JACC Cardiovasc Interv. 2020 May 11;13(9):1019-1027. doi: 10.1016/j.jcin.2020.02.008. Epub 2020 Feb 24.

  PMID: 32381181 DERIVED

• Ozaki Y, Garcia-Garcia HM, Rogers T, Torguson R, Craig PE, Hideo-Kajita A, Gordon P, Ehsan A, Parikh P, Bilfinger T, Butzel D, Buchanan S, Levitt R, Hahn C, Buchbinder M, Hanna N, Garrett R, Wilson SR, Goncalves JA, Ali S, Asch FM, Weissman G, Shults C, Ben-Dor I, Satler LF, Waksman R. Coronary Artery Disease Assessed by Computed Tomography-Based Leaman Score in Patients With Low-Risk Transcatheter Aortic Valve Implantation. Am J Cardiol. 2020 Apr 15;125(8):1216-1221. doi: 10.1016/j.amjcard.2020.01.022. Epub 2020 Jan 28.

  PMID: 32087995 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2015
• First Posted: December 11, 2015
• Study Start: January 1, 2016
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

US (11)