Aortic StenosisNCT03557242
Strategies to Prevent Transcatheter Heart Valve Dysfunction in Low Risk Transcatheter Aortic Valve Replacement
A study testing TAVR, Warfarin plus Aspirin and Aspirin Only in people with Aortic Stenosis, run by Medstar Health Research Institute at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- TAVR, Warfarin plus Aspirin and Aspirin Only
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 7 sitesUnited States
- Study dates
- 5 Jul 2018to 30 Jul 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Show all 27Show fewer
- 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:
- Porcelain or severely atherosclerotic aorta
- Frailty
- Hostile chest
- Internal mammary artery or other conduit either crosses midline of sternum or is adherent to sternum
- Severe pulmonary hypertension (PA systolic pressure > 2/3 of systemic pressure)
- Severe right ventricular dysfunction
- Ongoing sepsis or infective endocarditis
- Severe chronic obstructive pulmonary disease, as demonstrated by forced expiratory volume (FEV1) <750 cc
- Liver failure with Childs class C or D
- Pre-procedure shock, inotropes, mechanical assist device, or cardiac arrest
- Pregnancy or intent to become pregnant prior to completion of all protocol follow-up procedures
- Known allergy to warfarin or aspirin
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Henrico Doctors' Hospital
Richmond, Virginia, 23229
The Valley Hospital
Ridgewood, New Jersey, 07450
Foundation for Cardiovascular Medicine
San Diego, California, 92121
Stony Brook Hospital
Stony Brook, New York, 11794
St. John Health System
Tulsa, Oklahoma, 74104
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
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.
Read the detailed description
This study aims to examine the optimal anticoagulation/antiplatelet regimen in low risk patients undergoing TAVR. The prospective randomized controlled arm of this study will assess the utility of short-term oral anticoagulation with warfarin compared to antiplatelet therapy alone after TAVR in low risk patients to reduce the incidence of structural valve deterioration manifest as clinical events, increased aortic valve gradients or transvalvular regurgitation, or subclinical leaflet thrombosis. Low risk subjects with symptomatic severe aortic stenosis will be enrolled to undergo TAVR. Following TAVR, subjects will be randomized to receive warfarin plus low dose Aspirin or low dose Aspirin monotherapy for 30-45 days. Subjects with other indications for anticoagulation (e.g. AF, DVT or PE) will not be randomized and instead will be followed in a separate registry arm. Baseline demographic, clinical, non-invasive imaging (echocardiography and CT), TAVR procedural details, clinical follow up data will be prospectively collected for all subjects. Echocardiography and contrast-enhanced 4D cardiac CT will be performed in all subjects between 30-45 days after TAVR to evaluate for evidence of structural valve deterioration.
This multicenter prospective randomized study will enroll 200 consecutive low risk subjects with symptomatic severe aortic stenosis into the treatment arms of the study. Up to 100 additional subjects with a pre-existing indication for anticoagulation (e.g. atrial fibrillation, deep venous thrombosis or pulmonary embolism) or who are not eligible for randomization after TAVR due to development of a new indication for anticoagulation will be enrolled into the registry arm of the study.
Inclusion of this registry arm will ensure that the secondary objective pooled analysis of patient level data from this study and the Low Risk TAVR (LRT) study, truly represents an all-comers cohort of low risk patients undergoing TAVR, and does not exclude a significant subgroup.
- Conditions
- Aortic Stenosis
- Being tested
- TAVR, Warfarin plus Aspirin, Aspirin Only
- 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.
TAVRDevice
Transcatheter Aortic Valve Replacement
Warfarin plus AspirinOther
Subjects randomized to this arm will receive Warfarin plus aspirin for 30- 45 days post TAVR
Aspirin OnlyOther
Subjects randomized to this arm will receive aspirin only post TAVR
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: TAVR; Other: 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 Receives: Device: TAVR; Other: 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. Receives: Device: TAVR |
What is being measured
The primary outcome is the main question the study is designed to answer.
All Cause Mortality
Measured: 30 days
All Stroke
disabling and non-disabling, ischemic, hemorrhagic
Measured: 30 days
Life-threatening and Major Bleeding
Measured: 30 days
Major Vascular Complications
Measured: 30 Days
Hospitalizations for valve-related symptoms or worsening congestive heart failure
Measured: 30 days
Hypoattenuated leaflet thickening (HALT)
Measured: 30 days
At least moderately restricted leaflet motion (RELM)
Measured: 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)
Measured: 30 Days
Secondary outcomes (9)
VARC-2 device success:
- Absence of procedural mortality AND
- Correct positioning of a single prosthetic heart valve into the proper anatomical location AND
- Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient<20 mm Hg or peak velocity<3 m/s, AND no moderate or severe prosthetic valve regurgitation)
Measured: 1 year
All-cause mortality
Measured: 1 year
All stroke
(disabling and non-disabling, ischemic and hemorrhagic)
Measured: 1 year
Life-threatening and major bleeding
Measured: 1 year
Major vascular complications
Measured: 1 year
Hospitalizations for valve-related symptoms or worsening congestive heart failure
Measured: 1 year
Acute kidney injury
Measured: 1 year
Pacemaker implantation
Measured: 1 year
Endocarditis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start5 Jul 2018
- Primary completion30 Jul 2023 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ron S Waksman, MD, Principal investigator, MedStar Cardiovascular Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03557242
- Sponsor's protocol ID
- LRT 2.0
- Status last verified
- Jan 2022
- First submitted
- 29 May 2018
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 37832606Medranda 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.
PubMed 35321859Rogers 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.
PubMed 33423540
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies to Prevent Transcatheter Heart Valve Dysfunction in Low Risk Transcatheter Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT03557242
- Acronym / sponsor ID
- LRT 2.0
- Conditions
- Aortic Stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- 5 Jul 2018 (actual)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 14 Jun 2018 (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.
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.
Detailed description
This study aims to examine the optimal anticoagulation/antiplatelet regimen in low risk patients undergoing TAVR. The prospective randomized controlled arm of this study will assess the utility of short-term oral anticoagulation with warfarin compared to antiplatelet therapy alone after TAVR in low risk patients to reduce the incidence of structural valve deterioration manifest as clinical events, increased aortic valve gradients or transvalvular regurgitation, or subclinical leaflet thrombosis. Low risk subjects with symptomatic severe aortic stenosis will be enrolled to undergo TAVR. Following TAVR, subjects will be randomized to receive warfarin plus low dose Aspirin or low dose Aspirin monotherapy for 30-45 days. Subjects with other indications for anticoagulation (e.g. AF, DVT or PE) will not be randomized and instead will be followed in a separate registry arm. Baseline demographic, clinical, non-invasive imaging (echocardiography and CT), TAVR procedural details, clinical follow up data will be prospectively collected for all subjects. Echocardiography and contrast-enhanced 4D cardiac CT will be performed in all subjects between 30-45 days after TAVR to evaluate for evidence of structural valve deterioration.
This multicenter prospective randomized study will enroll 200 consecutive low risk subjects with symptomatic severe aortic stenosis into the treatment arms of the study. Up to 100 additional subjects with a pre-existing indication for anticoagulation (e.g. atrial fibrillation, deep venous thrombosis or pulmonary embolism) or who are not eligible for randomization after TAVR due to development of a new indication for anticoagulation will be enrolled into the registry arm of the study.
Inclusion of this registry arm will ensure that the secondary objective pooled analysis of patient level data from this study and the Low Risk TAVR (LRT) study, truly represents an all-comers cohort of low risk patients undergoing TAVR, and does not exclude a significant subgroup.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Warfarin plus Aspirin | Other | Device: TAVR, Other: Warfarin plus Aspirin100 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 |
| Aspirin Monotherapy | Other | Device: TAVR, Other: Aspirin Only100 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 |
| Registry Arm | Other | Device: TAVRUpto 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (27 listed)
- 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
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 |
|---|---|---|
| TAVRTranscatheter Aortic Valve Replacement | Device | Aspirin Monotherapy, Registry Arm, Warfarin plus Aspirin |
| Warfarin plus AspirinSubjects randomized to this arm will receive Warfarin plus aspirin for 30- 45 days post TAVR | Other | Warfarin plus Aspirin |
| Aspirin OnlySubjects randomized to this arm will receive aspirin only post TAVR | Other | Aspirin Monotherapy |
Primary outcome
All Cause Mortality
Time frame: 30 days
All Stroke
Time frame: 30 days
disabling and non-disabling, ischemic, hemorrhagic
Life-threatening and Major Bleeding
Time frame: 30 days
Major Vascular Complications
Time frame: 30 Days
Hospitalizations for valve-related symptoms or worsening congestive heart failure
Time frame: 30 days
Hypoattenuated leaflet thickening (HALT)
Time frame: 30 days
At least moderately restricted leaflet motion (RELM)
Time frame: 30 days
Hemodynamic dysfunction
Time frame: 30 Days
(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)
9 secondary outcomes
VARC-2 device success:
Time frame: 1 year
All-cause mortality
Time frame: 1 year
All stroke
Time frame: 1 year
Life-threatening and major bleeding
Time frame: 1 year
Major vascular complications
Time frame: 1 year
Hospitalizations for valve-related symptoms or worsening congestive heart failure
Time frame: 1 year
Acute kidney injury
Time frame: 1 year
Pacemaker implantation
Time frame: 1 year
Endocarditis
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Derived from this study: PubMed 37832606Bhogal 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.
- Derived from this study: PubMed 35321859Medranda 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.
- Derived from this study: PubMed 33423540Rogers 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.
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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.
Ron S Waksman, MD principal investigator
MedStar Cardiovascular Research Network
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAVR, Warfarin plus Aspirin and Aspirin Only in people with Aortic Stenosis, run by Medstar Health Research Institute at 7 sites 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 14 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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.
Are results available for this study?
Results are not available in the source record.
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?
All Cause Mortality (time frame: 30 days). The study lists 8 primary outcomes in all. 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 NCT03557242, which also lists 3 linked publications.
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 4 Jan 2022.