REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System - Evaluation of Safety and Performance

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01627691
First received: June 5, 2012
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Transcatheter Aortic Valve Replacement
Device: Lotus Valve System
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System - Evaluation of Safety and Performance

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Primary Device Performance Endpoint: Mean aortic valve pressure gradient at 30 days post implant procedure [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Mean aortic valve pressure gradient at 30 days post implant procedure as measured by echocardiography and assessed by an independent core laboratory.

  • Primary Safety Endpoint: All-cause mortality at 30 days post implant procedure [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    All-cause mortality at 30 days post implant procedure


Enrollment: 120
Study Start Date: October 2012
Estimated Study Completion Date: March 2018
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lotus Valve System
Patients enrolled will receive the Lotus Valve.
Device: Lotus Valve System
  • bioprosthetic bovine pericardial aortic valve
  • delivery system

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is ≥70 years of age
  • Subject has documented calcific native aortic valve stenosis
  • Subject has a documented aortic annulus size between ≥19 and ≤27 mm based on pre-procedure diagnostic imaging
  • Symptomatic aortic valve stenosis with NYHA Functional Class ≥ II
  • Subject is considered high risk for surgical valve replacement
  • Heart team assessment that the subject is likely to benefit from valve replacement.
  • Subject (or legal representative) understands the study requirements and the treatment procedures, and provides written informed consent.
  • 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.

Exclusion Criteria:

  • Subject has a congenital unicuspid or bicuspid aortic valve.
  • Subject with an acute myocardial infarction within 30 days of the index procedure
  • Subject has had a cerebrovascular accident or transient ischemic attack within the past 6 months, or has any permanent neurologic defect prior to study enrollment.
  • Subject is on dialysis or has serum creatinine level >3.0 mg/dL or 265 µmol/L.
  • Subject has a pre-existing prosthetic heart valve (aortic or mitral) or a prosthetic ring in any position.
  • subject cannot have more than moderate mitral, aortic or tricuspid regurgitation
  • Subject has a need for emergency surgery for any reason.
  • Subject has a history of endocarditis within 12 months of index procedure or evidence of an active systemic infection or sepsis.
  • Subject has echocardiographic evidence of intra-cardiac mass, thrombus or vegetation.
  • Subject has low Hgb, platelet count or >700,000 cells/mm3, or low white blood cell count.
  • Subject requires chronic anticoagulation therapy and cannot tolerate concomitant therapy with either aspirin or clopidogrel/ticlopidine
  • Subject has active peptic ulcer disease or gastrointestinal bleed within the past 3 months, other bleeding diathesis or coagulopathy or will refuse transfusions.
  • Subject has known hypersensitivity to contrast agents that cannot be adequately pre-medicated, or has known hypersensitivity to aspirin, all thienopyridines, heparin, nickel, tantalum, titanium, or polyurethanes.
  • Subject has a life expectancy of less than 12 months due to non-cardiac, co-morbid conditions based on the assessment of the investigator at the time of enrollment.
  • Subject has hypertrophic obstructive cardiomyopathy.
  • Subject has any therapeutic invasive cardiac procedure within 30 days prior to the index procedure (except for pacemaker implantation which is allowed).
  • Subject has untreated coronary artery disease.
  • Subject has documented left ventricular ejection fraction <30%.
  • Subject is in cardiogenic shock or has hemodynamic instability requiring inotropic support or mechanical support devices.
  • Subject has severe peripheral vascular disease or symptomatic carotid or vertebral disease.
  • Narrow Femoral artery lumen precludes the use of either Lotus device size, or severe iliofemoral tortuosity or calcification that would prevent safe placement of the introducer sheath.
  • Current problems with substance abuse (e.g., alcohol, etc.).
  • Subject is participating in another investigational drug or device study that has not reached its primary endpoint.
  • Patient has preexisting untreated conduction system disorder that requires new pacemaker implantation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01627691

Locations
Australia
Royal Adelaide Hospital
Adelaide, Australia
Prince Charles Hospital
Brisbane, Australia
Monash Medical Center
Melbourne, Australia
St. Vincent's Hospital
Melbourne, Australia
France
Hôpital Cardiologique de Lyon
Lyon, France
Institut Cardiovasculaire Paris Sud
Paris, France
Centre Hôpital Universitaire Rangueil
Toulouse, France
Clinique Pasteur
Toulouse, France
Germany
Herzzentrum Universität Leipzig
Leipzig, Germany
Deutsches Herzzentrum München
München, Germany
Helios Klinikum Siegburg
Siegburg, Germany
United Kingdom
Royal Victoria Hospital
Belfast, United Kingdom
Royal Sussex County Hospital
Brighton, United Kingdom
The General Infirmary
Leeds, United Kingdom
Guys and St. Thomas NHS Foundation Trust
London, United Kingdom
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Ian Meredith, Professor Monash Medical Centre
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01627691     History of Changes
Other Study ID Numbers: TP3687, TP3687
Study First Received: June 5, 2012
Last Updated: January 14, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee
France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Institutional Ethical Committee
Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

ClinicalTrials.gov processed this record on April 15, 2014