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Trial record 2 of 3 for:    MedStar Health | Recruiting Studies | "Ventricular Outflow Obstruction"

Strategies to Prevent Transcatheter Heart Valve Dysfunction in Low Risk Transcatheter Aortic Valve Replacement

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ClinicalTrials.gov Identifier: NCT03557242
Recruitment Status : Recruiting
First Posted : June 14, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Medstar Health Research Institute

Tracking Information
First Submitted Date  ICMJE May 29, 2018
First Posted Date  ICMJE June 14, 2018
Last Update Posted Date December 6, 2018
Actual Study Start Date  ICMJE July 5, 2018
Estimated Primary Completion Date July 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2018)
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03557242 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2018)
  • VARC-2 device success: [ Time Frame: 1 year ]
    • 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)
  • All-cause mortality [ Time Frame: 1 year ]
  • All stroke [ Time Frame: 1 year ]
    (disabling and non-disabling, ischemic and hemorrhagic)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Strategies to Prevent Transcatheter Heart Valve Dysfunction in Low Risk Transcatheter Aortic Valve Replacement
Official Title  ICMJE Strategies to Prevent Transcatheter Heart Valve Dysfunction in Low Risk Transcatheter Aortic Valve Replacement
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Aortic Stenosis
Intervention  ICMJE
  • Device: TAVR
    Transcatheter Aortic Valve Replacement
  • Other: Warfarin plus Aspirin
    Subjects randomized to this arm will receive Warfarin plus aspirin for 30- 45 days post TAVR
  • Other: Aspirin Only
    Subjects randomized to this arm will receive aspirin only post TAVR
Study Arms  ICMJE
  • Warfarin plus Aspirin
    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
    Interventions:
    • Device: TAVR
    • Other: Warfarin plus Aspirin
  • Aspirin Monotherapy
    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
    Interventions:
    • Device: TAVR
    • Other: Aspirin Only
  • Registry Arm
    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.
    Intervention: Device: TAVR
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 13, 2018)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 30, 2023
Estimated Primary Completion Date July 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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:
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Roshni S Bastian, MBA, MPH 2028777752 roshni.s.bastian@medstar.net
Contact: Rebecca Torguson, MPH 2028772194 rebecca.torguson@medstar.net
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03557242
Other Study ID Numbers  ICMJE LRT 2.0
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medstar Health Research Institute
Study Sponsor  ICMJE Medstar Health Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ron S Waksman, MD MedStar Cardiovascular Research Network
PRS Account Medstar Health Research Institute
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP