Performance and Safety of the Lotus™ Valve With a FLEXible Delivery System

NCT03043404 | Completed

• 1 other identifier: S2321
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

Brief Summary

To confirm the acute performance and safety of the Lotus™ Valve Flex System for transcatheter aortic valve replacement (TAVR) in symptomatic patients with severe calcific aortic stenosis who are considered high risk for surgical valve replacement.

Conditions

Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

• Technical success

  defined as successful vascular access, delivery and deployment of the Lotus Valve and successful retrieval of the delivery system; and correct positioning of a single Lotus Valve in the proper anatomical location; reported as percent of subjects.

  immediately post-procedure

Secondary Outcomes (2)

• Mean aortic valve pressure gradient and effective orifice area

  at discharge or 7 days post-procedure (whichever comes first)

• Device performance

  at discharge or 7 days post-procedure (whichever comes first)

Other Outcomes (22)

• Mortality: all-cause, cardiovascular, and non-cardiovascular

  at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure

• Stroke: disabling and non-disabling

  at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure

• Composite of all-cause mortality and disabling stroke

  at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure

Study Arms (1)

Lotus Valve Flex System

EXPERIMENTAL

Transcatheter aortic valve replacement (TAVR) with Lotus Valve FLEX System

Device: Transcatheter aortic valve replacement

Interventions

Transcatheter aortic valve replacement DEVICE

TAVR with Lotus Valve Flex System

Lotus Valve Flex System

Eligibility Criteria

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

You may qualify if:

• \. Subject is ≥70 years of age
• \. Subject has documented calcific native aortic valve stenosis with an initial aortic valve area (AVA) of \<1.0 cm2 (or AVA index of \<0.6 cm2/m2) and either a mean pressure gradient \>40 mm Hg or a jet velocity \>4 m/s, as measured by echocardiography
• \. Subject has a documented aortic annulus size between ≥20 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 based on at least one of the following:
• Society of Thoracic Surgeons (STS) score ≥8%, AND/OR
• Agreement by the heart team (which must include an in-person evaluation by an experienced cardiac surgeon) that subject is at high operative risk of serious morbidity or mortality with surgical valve replacement
• \. Heart team (which must include an experienced cardiac surgeon) 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.

You may not qualify if:

• Subject has a congenital unicuspid or bicuspid aortic valve.
• Subject with an acute myocardial infarction within 30 days of the index procedure (defined as Q-wave MI or non-Q-wave MI with total CK elevation ≥ twice normal in the presence of CK-MB elevation and/or troponin elevation).
• 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 has ≥3+ mitral regurgitation, ≥3+ aortic regurgitation or ≥3+ tricuspid regurgitation (i.e., 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 Hgb \<9 g/dL, platelet count \<50,000 cells/mm3 or \>700,000 cells/mm3, or white blood cell count \<1,000 cells/mm3.
• Subject requires chronic anticoagulation therapy (warfarin) and cannot tolerate concomitant therapy with either aspirin or clopidogrel.
• Note: Subjects who require chronic anticoagulation must be able to be treated additionally with either aspirin or clopidogrel. An alternative P2Y12 inhibitor may be prescribed if subject is allergic to or intolerant of clopidogrel.
• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (2)

Prince Charles Hospital

Chermside, Queensland, 4032, Australia

Location

Monash Heart

Clayton, Victoria, 3168, Australia

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Ian T Meredith, MD, PhD

  Monash

  PRINCIPAL INVESTIGATOR

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: February 1, 2017
• First Posted: February 6, 2017
• Study Start: December 3, 2013
• Primary Completion: December 10, 2013
• Study Completion: December 10, 2018
• Last Updated: July 5, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)