REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve SystEm

NCT01383720 | Completed Results

• 1 other identifier: TP3659
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 3

Brief Summary

This is a prospective, single-arm feasibility study designed to assess the acute safety and performance of the Lotus Valve System for transcatheter aortic valve replacement in symptomatic patients with calcified aortic valve stenosis and who are at high risk for surgical intervention.

Conditions

Aortic Valve Stenosis; Aortic Valve Calcification; Aortic Valve Disease

Keywords

Aortic Valve Stenosis; Transcatheter Aortic Valve Replacement

Outcome Measures

Primary Outcomes (1)

• Clinical Procedural Success

  Clinical procedural success defined as successful implantation of a Lotus Valve System (Device Success) without in-hospital Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) through discharge or 7 days post-procedure, whichever comes first.

  Discharge or 7 days post-procedure, whichever comes first

Secondary Outcomes (4)

• Device Performance Endpoint-Repositioning

  procedure

• Device Performance Endpoint-Valve Retrieval, if Attempted

  procedure

• Central Aortic Regurgitation

  Discharge or 7 days post-procedure, whichever comes first

• Paravalvular Aortic Regurgitation

  Discharge or 7 days post-procedure, whichever comes first

Other Outcomes (14)

• Successful Access, Device Delivery, Deployment and Positioning and Retrieval of Delivery System

  Procedure

• Intended Performance of the Lotus Valve

  At time of discharge or 7 days post procedure

• Single Valve Implanted in the Proper Anatomical Location

  procedure

Study Arms (1)

Lotus Valve System

EXPERIMENTAL

Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis

Device: Lotus Valve System

Interventions

Lotus Valve System DEVICE

The Lotus Valve System includes the Lotus Valve, a bovine tissue tri-leaflet bioprosthetic aortic valve, and the Lotus Delivery Catheter for guidance and placement.

Lotus Valve System

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patient must be at least 70 years of age or older, and meets all of the criteria below.
• Patient has documented calcified native aortic valve stenosis, defined 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 mmHg or a jet velocity \>4 m/s, as measured by echocardiography.
• The patient is considered at high risk for surgical aortic valve replacement with an STS (Society of Thoracic Surgeons) score ≥8% or a EuroSCORE ≥20%, or documented multidisciplinary heart team agreement that the patient is at high risk for surgery due to frailty and/or coexisting comorbidities.
• Symptomatic aortic valve stenosis with New York Heart Association (NYHA) Functional Class ≥ II.
• Patient has a documented aortic annulus size between 19 and 22 mm (able to accommodate the 23 mm Lotus™ Valve). Pre-procedure measurement by transthoracic echocardiography (TTE) is required. Other imaging modalities (e.g., transesophageal echocardiography (TEE), CT scan) can be used in an adjunctive manner.
• Patient (or legal representative) understands the trial requirements and the treatment procedures, and provides written informed consent.
• Patient agrees and is capable of returning to the study hospital for all required scheduled follow up visits.

You may not qualify if:

• Patient has a congenital unicuspid or bicuspid aortic valve.
• Patient with an acute myocardial infarction (MI) within 30 days of 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 CK-MB elevation and/or troponin level elevation (WHO definition)).
• Patient has had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months, or has any permanent neurologic defect prior to study enrollment.
• Patient is on dialysis or has serum creatinine level \>3.0 mg/dL.
• Patient has a pre-existing prosthetic heart valve (aortic or mitral) or a prosthetic ring in any position.
• Patient has \>2+ mitral regurgitation or \>2+ aortic regurgitation (ie., patient cannot have more than moderate mitral or aortic regurgitation).
• Moderate to severe pulmonary hypertension (PA systolic pressure \>60 mm Hg) as assessed by transthoracic echocardiography.
• Patient has a need for emergency surgery for any reason.
• Patient has a history of endocarditis within 12 months of index procedure or evidence of an active systemic infection or sepsis.
• Patient has echocardiographic evidence of intra-cardiac mass, thrombus or vegetation.
• Patient has Hgb \<9 g/dL, platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3, and white blood cell (WBC) count \<3,000 cells/mm3.
• Patient is receiving chronic (≥72 hours) anticoagulation therapy (e.g., heparin, warfarin) and who cannot tolerate concomitant therapy with aspirin and clopidogrel (patients who require chronic anticoagulation must be treated with either aspirin or clopidogrel).
• Patient has active peptic ulcer disease, gastrointestinal (GI) bleed within the past 3 months, other bleeding diathesis or coagulopathy or will refuse transfusions.
• Patient is contraindicated for transesophageal echocardiography (TEE).
• Patient has known hypersensitivity to contrast agents that cannot be adequately pre-medicated, or has known hypersensitivity to aspirin, all thienopyridines, heparin, nickel, titanium, or polyurethanes.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (3)

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

St. Vincent's Hospital

Melbourne, Victoria, 3040, Australia

Location

Southern Health Monash Medical Centre

Melbourne, Victoria, 3168, Australia

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve, Calcification of; Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Results Point of Contact

• Title: Director of Clinical Trials, Valves
• Organization: Boston Scientific Corporation

408-370-1550

Study Officials

• Ian Meredith, MBBS, PhD

  Southern Health, Monash Medical Centre

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2011
• First Posted: June 28, 2011
• Study Start: April 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: May 9, 2017
• Last Updated: June 20, 2017
• Results First Posted: May 9, 2016

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)