NCT03557242

Brief Summary

100 subjects in the each of the treatment arms of the study (total 200 treatment arm subjects) and up to 100 subjects in the registry arm of the study.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 14, 2018

Completed
21 days until next milestone

Study Start

First participant enrolled

July 5, 2018

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
Last Updated

January 4, 2022

Status Verified

January 1, 2022

Enrollment Period

5.1 years

First QC Date

May 29, 2018

Last Update Submit

January 3, 2022

Conditions

Aortic Stenosis

Outcome Measures

Primary Outcomes (8)

  • All Cause Mortality

    30 days

  • All Stroke

    disabling and non-disabling, ischemic, 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

  • Hypoattenuated leaflet thickening (HALT)

    30 days

  • At least moderately restricted leaflet motion (RELM)

    30 days

  • Hemodynamic dysfunction

    (mean aortic valve gradient ≥20 mm Hg, AND/OR EOA ≤1.0 cm2 AND/OR DVI\<0. 35, AND/OR moderate or severe prosthetic valve regurgitation)

    30 Days

Secondary Outcomes (9)

  • VARC-2 device success:

    1 year

  • All-cause mortality

    1 year

  • All stroke

    1 year

  • Life-threatening and major bleeding

    1 year

  • Major vascular complications

    1 year

  • +4 more secondary outcomes

Study Arms (3)

Warfarin plus Aspirin

OTHER

100 subjects will be randomized electronically through the Electronic Data Capture System in a 1:1 fashion to warfarin plus low dose aspirin for 30-45 days

Device: TAVROther: Warfarin plus Aspirin

Aspirin Monotherapy

OTHER

100 subjects will be randomized electronically through the Electronic Data Capture System in a 1:1 fashion to low dose aspirin monotherapy for 30-45 days

Device: TAVROther: Aspirin Only

Registry Arm

OTHER

Upto an additional 100 subjects with preexisting indication for anti coagulation (e.g. atrial fibrillation, deep venous thrombosis, pulmonary embolism) or who are not eligible for randomization after TAVR due to development of a new indication for anti coagulation will be enrolled in the registry arm of the study.

Device: TAVR

Interventions

TAVRDEVICE

Transcatheter Aortic Valve Replacement

Aspirin MonotherapyRegistry ArmWarfarin plus Aspirin
Warfarin plus AspirinOTHER

Subjects randomized to this arm will receive Warfarin plus aspirin for 30- 45 days post TAVR

Warfarin plus Aspirin
Aspirin OnlyOTHER

Subjects randomized to this arm will receive aspirin only post TAVR

Aspirin Monotherapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (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 agrees that the patient is low-risk, quantified by an estimated risk of death ≤3% by the calculated STS score for operative mortality at 30 days; AND agrees that SAVR would be an appropriate therapy if offered
  • A surgeon who is experienced in Surgical Aortic Valve Replacement (SAVR) has spoken with the patient in person and stipulates that the patient understands his/her alternatives for FDA approved therapy, including open heart surgery to replace their aortic valve
  • The institutional Heart Team determines that transfemoral TAVR is appropriate
  • Aortic valve anatomy and dimensions suitable for TAVR using a commercially available valve
  • Iliofemoral artery anatomy and dimensions suitable for transfemoral TAVR using a commercially available valve and delivery system
  • Procedure status is elective
  • Expected survival is at least 24 months

You may not qualify if:

  • Subject unable or unwilling to give informed consent
  • 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
  • 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
  • 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 (Table 2 - HASBLED scoring system)
  • 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:
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Foundation for Cardiovascular Medicine

San Diego, California, 92121, United States

Location

Washington Hospital Center

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

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Henrico Doctors' Hospital

Richmond, Virginia, 23229, United States

Location

Related Publications (3)

  • 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: 37832606DERIVED

  • 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: 35321859DERIVED

  • Rogers T, Shults C, 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, Moreno R, Zhang C, Craig P, Asch FM, Weissman G, Garcia-Garcia HM, Ben-Dor I, Satler LF, Waksman R. Randomized Trial of Aspirin Versus Warfarin After Transcatheter Aortic Valve Replacement in Low-Risk Patients. Circ Cardiovasc Interv. 2021 Jan;14(1):e009983. doi: 10.1161/CIRCINTERVENTIONS.120.009983. Epub 2021 Jan 11.

    PMID: 33423540DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

WarfarinAspirin

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Ron S Waksman, MD

    MedStar Cardiovascular Research Network

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2018

First Posted

June 14, 2018

Study Start

July 5, 2018

Primary Completion

July 30, 2023

Study Completion

July 30, 2023

Last Updated

January 4, 2022

Record last verified: 2022-01

Locations

US(7)