Trial record 6 of 225 for:    aortic valve replacement

Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement (REPRISE III)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT02202434
First received: July 21, 2014
Last updated: October 2, 2014
Last verified: October 2014
  Purpose

The objective of this study is to evaluate the safety and effectiveness of the Lotus™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe native aortic stenosis who are considered at extreme or high risk for surgical valve replacement.


Condition Intervention
Aortic Stenosis
Device: Lotus Valve System
Device: CoreValve Transcatheter Aortic Valve Replacement System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: REPRISE III: Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System - Randomized Clinical Evaluation

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Primary Safety Endpoint: Composite of all-cause mortality, stroke, life-threatening and major bleeding events, stage 2 or 3 acute kidney injury, or major vascular complications [ Time Frame: 30 days following procedure ] [ Designated as safety issue: Yes ]
  • Primary Effectiveness Endpoint: Composite of all-cause mortality, disabling stroke, or moderate or greater paravalvular aortic regurgitation (based on core lab assessment) [ Time Frame: 1 year following procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Moderate or greater paravalvular aortic regurgitation (based on core lab assessment) [ Time Frame: 1 year following procedure ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Successful deployment of the study valve [ Time Frame: at discharge or 7 days post-procedure (whichever comes first) ] [ Designated as safety issue: Yes ]
  • Successful retrieval of the study valve if retrieval is attempted [ Time Frame: at discharge or 7 days post-procedure (whichever comes first) ] [ Designated as safety issue: Yes ]
  • Successful repositioning of the study valve if repositioning is attempted [ Time Frame: at discharge or 7 days post-procedure (whichever comes first) ] [ Designated as safety issue: Yes ]
  • Grade of aortic valve regurgitation: paravalvular, central, and combined [ Time Frame: at discharge or 7 days post-procedure (whichever comes first) ] [ Designated as safety issue: Yes ]
  • Clinical procedural success [ Time Frame: 30 days post procedure ] [ Designated as safety issue: Yes ]
    Defined as implantation of the study device in the absence of death, disabling stroke, major vascular complications, and life-threatening or major bleeding

  • Procedural success [ Time Frame: 30 days post procedure ] [ Designated as safety issue: Yes ]
    defined as absence of procedural mortality, correct positioning of a single transcatheter valve into the proper anatomical location , intended performance of the study device (effective orifice area [EOA] >0.9 cm2 for body surface area (BSA) <1.6 m2 and EOA >1.1 cm2 for BSA ≥1.6 m2 plus either a mean aortic valve gradient <20 mm Hg or a peak velocity <3m/sec, and no moderate or severe prosthetic valve aortic regurgitation) plus no serious adverse events

  • Additional indications of prosthetic aortic valve performance as measured by transthoracic echocardiography [ Time Frame: At discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure ] [ Designated as safety issue: No ]
    assessed by an independent core laboratory, including effective orifice area, mean and peak aortic gradients, peak aortic velocity, and grade of aortic regurgitation

  • Health status as evaluated by Quality of Life questionnaires [ Time Frame: baseline, 1 and 6 months; and 1, 3, and 5 years ] [ Designated as safety issue: No ]
    SF-12 and Kansas City Cardiomyopathy

  • Mortality: all-cause, cardiovascular, and non-cardiovascular [ Time Frame: At discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure ] [ Designated as safety issue: Yes ]
  • Stroke: disabling and non-disabling [ Time Frame: At discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure ] [ Designated as safety issue: Yes ]
  • Myocardial infarction (MI): periprocedural (≤72 hours post index procedure) and spontaneous (>72 hours post index procedure) [ Time Frame: At discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure ] [ Designated as safety issue: Yes ]
  • Bleeding: life-threatening (or disabling) and major [ Time Frame: At discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure ] [ Designated as safety issue: Yes ]
  • Acute kidney injury based on the AKIN System Stage 3 (including renal replacement therapy) or Stage 2 [ Time Frame: ≤7 days post index procedure ] [ Designated as safety issue: Yes ]
  • Major vascular complication [ Time Frame: At discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure ] [ Designated as safety issue: Yes ]
  • Repeat procedure for valve-related dysfunction (surgical or interventional therapy) [ Time Frame: At discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure ] [ Designated as safety issue: Yes ]
  • Hospitalization for valve-related symptoms or worsening congestive heart failure (New York Hear Association [NYHA] class III or IV) [ Time Frame: At discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure ] [ Designated as safety issue: Yes ]
  • New permanent pacemaker implantation resulting from new or worsened conduction disturbances [ Time Frame: At discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure ] [ Designated as safety issue: Yes ]
  • New onset of atrial fibrillation or atrial flutter [ Time Frame: At discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure ] [ Designated as safety issue: Yes ]
  • Coronary obstruction [ Time Frame: ≤72 hours post index procedure ] [ Designated as safety issue: Yes ]
  • Ventricular septal perforation [ Time Frame: ≤72 hours post index procedure ] [ Designated as safety issue: Yes ]
  • Mitral apparatus damage [ Time Frame: ≤72 hours post index procedure ] [ Designated as safety issue: Yes ]
  • Cardiac tamponade [ Time Frame: ≤72 hours post index procedure ] [ Designated as safety issue: Yes ]
  • Prosthetic aortic valve malpositioning, including valve migration, valve embolization, or ectopic valve deployment [ Time Frame: at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure ] [ Designated as safety issue: Yes ]
  • Prosthetic aortic valve thrombosis [ Time Frame: at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure ] [ Designated as safety issue: Yes ]
  • Prosthetic aortic valve endocarditis [ Time Frame: at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1032
Study Start Date: September 2014
Estimated Study Completion Date: January 2021
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lotus Valve System
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Device: Lotus Valve System
Transcatheter aortic valve replacement (TAVR) with the Lotus Valve System
Active Comparator: CoreValve Transcatheter Aortic Valve Replacement System
Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System
Device: CoreValve Transcatheter Aortic Valve Replacement System
Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject has documented calcific, severe native aortic stenosis with an initial aortic valve area (AVA) of ≤1.0 cm2 (or AVA index of <0.6 cm2/m2) and a mean pressure gradient >40 mm Hg or jet velocity >4.0 m/s, as measured by echocardiography
  2. Subject has a documented aortic annulus size of ≥20 mm and ≤27 mm based on the center's assessment of pre-procedure diagnostic imaging (and confirmed by the Case Review Committee [CRC]) and is deemed treatable with an available size of both test and control device
  3. Subject has symptomatic aortic valve stenosis with New York Heart Association (NYHA) Functional Class ≥ II
  4. There is agreement by the heart team (which must include a site investigator interventionalist and a site investigator cardiac surgeon) that subject is at high or extreme operative risk for surgical valve replacement (see note below for definitions of extreme and high risk, the required level of surgical assessment, and CRC confirmation) and that TAVR is appropriate. Additionally, subject has at least one of the following.

    • Society of Thoracic Surgeons (STS) score ≥8% -OR-
    • If STS <8, subject has at least one of the following conditions: Hostile chest, porcelain aorta, severe pulmonary hypertension (>60 mmHg), prior chest radiation therapy, coronary artery bypass graft(s) at risk with re-operation, severe lung disease (need for supplemental oxygen, forced expiratory volume in 1 second [FEV1] <50% of predicted, diffusing capacity of the lungs for carbon monoxide [DLCO] <60%, or other evidence of severe pulmonary dysfunction), neuromuscular disease that creates risk for mechanical ventilation or rehabilitation after surgical aortic valve replacement, orthopedic disease that creates risk for rehabilitation after surgical aortic valve replacement, Childs Class A or B liver disease (subjects with Childs Class C disease are not eligible for inclusion in this trial), frailty as indicated by at least one of the following: 5‑meter walk >6 seconds, Katz Assessment of Daily Living (Katz ADL) score of 3/6 or less, body mass index <21, wheelchair bound, unable to live independently, other evidence that subject is at high or extreme risk for surgical valve replacement (CRC must confirm agreement with site heart team that subject meets high or extreme risk definition)
  5. Heart team (which must include a cardiac interventionalist and an experienced cardiac surgeon) assessment that the subject is likely to benefit from valve replacement.
  6. Subject (or legal representative) understands the study requirements and the treatment procedures, and provides written informed consent.
  7. Subject, family member, and/or legal representative agree(s) and subject is capable of returning to the study hospital for all required scheduled follow up visits.

Note: Extreme operative risk and high operative risk are defined as follows: Extreme Operative Risk: Predicted operative mortality or serious, irreversible morbidity risk ≥50% at 30 days; High Operative Risk: Predicted operative mortality or serious, irreversible morbidity risk ≥15% at 30 days. Risk of operative mortality and morbidity must be assessed via an in-person evaluation by a center cardiac surgeon and must be confirmed by the CRC (which must include an experienced cardiac surgeon).

Exclusion Criteria:

  1. Subject has a congenital unicuspid or bicuspid aortic valve.
  2. Subject has had an acute myocardial infarction (MI) within 30 days prior to the index procedure (defined as Q-wave MI or non-Q-wave MI with total creatine kinase (CK) elevation ≥ twice normal in the presence of creatine kinase-myoglobin band (CK-MB) elevation and/or troponin elevation).
  3. Subject has had a cerebrovascular accident or transient ischemic attack within the past 6 months prior to study enrollment.
  4. Subject has end-stage renal disease or has glomerular filtration rate (GFR) <20 (based on Cockcroft-Gault formula).
  5. Subject has a pre-existing prosthetic aortic or mitral valve.
  6. Subject has severe (≥3+) aortic, tricuspid, or mitral regurgitation.
  7. Subject has a need for emergency surgery for any reason.
  8. Subject has a history of endocarditis within 6 months of index procedure or evidence of an active systemic infection or sepsis.
  9. Subject has echocardiographic evidence of new intra-cardiac mass, thrombus or vegetation or one requiring treatment.
  10. Subject has (hemoglobin) Hgb <9 g/dL, platelet count <50,000 cells/mm3 or >700,000 cells/mm3, or white blood cell count <1,000 cells/mm3.
  11. Subject is being treated with chronic anticoagulation therapy other than warfarin. Note: Subjects who require chronic anticoagulation with warfarin must be able to be treated additionally with either aspirin or clopidogrel.
  12. Subject has active peptic ulcer disease or gastrointestinal bleed requiring hospitalization or transfusion within the past 3 months, other clinically significant bleeding diathesis or coagulopathy or will refuse transfusions.
  13. Subject has known hypersensitivity to contrast agents that cannot be adequately pre-medicated, or has known hypersensitivity to aspirin, all P2Y12 inhibitors, heparin, nickel, tantalum, titanium, or polyurethanes.
  14. Subject has a life expectancy of less than 12 months due to non-cardiac, comorbid conditions based on the assessment of the investigator at the time of enrollment.
  15. Subject has hypertrophic obstructive cardiomyopathy.
  16. Subject has any therapeutic invasive cardiac or vascular procedure within 30 days prior to the index procedure (except for balloon aortic valvuloplasty or pacemaker implantation, which are allowed).
  17. Subject has untreated coronary artery disease, which in the opinion of the treating physician is clinically significant and requires revascularization.
  18. Subject has severe left ventricular dysfunction with ejection fraction <20%.
  19. Subject is in cardiogenic shock or has hemodynamic instability requiring inotropic support or mechanical support devices.
  20. Subject has severe peripheral vascular disease including aneurysm defined as maximal luminal diameter ≥5 cm or with documented presence of thrombus, marked tortuosity, narrowing of the abdominal aorta, severe unfolding of the thoracic aorta, or symptomatic carotid or vertebral disease.
  21. Subject has thick (>5 mm) protruding or ulcerated atheroma in the aortic arch
  22. Subject has arterial access that is not acceptable for the test and control device delivery systems as defined in the device Instructions For Use.
  23. Subject has current problems with substance abuse (e.g., alcohol, etc.).
  24. Subject is participating in another investigational drug or device study that has not reached its primary endpoint.
  25. Subject has untreated conduction system disorder (e.g., Type II second degree atrioventricular block) that in the opinion of the treating physician is clinically significant and requires a pacemaker implantation. Enrollment is permissible after permanent pacemaker implantation.
  26. Subject has severe incapacitating dementia.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02202434

Locations
United States, Illinois
Evanston Hospital
Evanston, Illinois, United States, 60201
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Ted Feldman, MD NorthShore University HealthSystem Research Institute
Principal Investigator: Mchael J Reardon, MD The Methodist Hospital System
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT02202434     History of Changes
Other Study ID Numbers: S2282
Study First Received: July 21, 2014
Last Updated: October 2, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on October 19, 2014