Transfemoral Implant of Inovare® Transcatheter Valve

NCT05531578 | Active Not Recruiting DMC

• 1 other identifier: Inovare - Transfemoral
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

Brief Summary

Clinical trial to evaluate the early safety and efficacy of the transfemoral implant of Inovare® Transcatheter Valve for the treatment of patients with severe degenerative aortic stenosis and high surgical risk.

Conditions

Aortic Valve Stenosis

Keywords

TAVI; TAVR; Transfemoral; Transcatheter Valve

Outcome Measures

Primary Outcomes (2)

• Device success

  Absence of mortality in the procedure AND correct positioning of a single bioprosthesis with the intended performance (mean gradient \< 20 mmHg and regurgitation ≥ moderate).

  Procedure

• Death the first 30 days

  Deaths from any cause within the first 30 days of the procedure or during hospital stay will be considered procedure-related deaths.

  30 days

Secondary Outcomes (3)

• Device success

  30 days or more

• Incidence of serious adverse events

  30 days or more

• Efficacy of the procedure

  30 days or more

Study Arms (1)

TAVI TRANSFEMORAL

EXPERIMENTAL

Device: INOVARE® Transcatheter Valve, NexusCath Delivery System, Aureus Expandable Introducer, Balloon Catheter for Pre-Dilation and Compression Device (Crimper)

Interventions

INOVARE® Transcatheter Valve, NexusCath Delivery System, Aureus Expandable Introducer, Balloon Catheter for Pre-Dilation and Compression Device (Crimper) DEVICE

Transfemoral implantation of the INOVARE® transcatheter valve

TAVI TRANSFEMORAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Calcified degenerative aortic stenosis with valve area \< 1.0 cm2 (or valve area index \< 0.6 cm2/m2) and mean transvalvular gradient \> 40 mmHg or aortic jet velocity \> 4 m/s by echocardiogram.
• Multidisciplinary evaluation by the "Heart Team", composed of a cardiovascular surgeon, clinical cardiologist and hemodynamicist, which concludes that the patient has:
• High surgical risk for aortic valve replacement, typically with an STS score of ≥ 8% (or logistic EuroSCORE ≥ 20%) or intermediate risk (STS of ≥ 3% and \< 8%);
• Presence of porcelain aorta or hostile chest, as well as global clinical condition and comorbidities not fully addressed by the score STS
• Presence of extreme frailty (5-meter walk test \[5MWT\], grip strength, activities of daily living (ADL), and albumin laboratory exam);
• Considerable chance of clinical benefit with the transcatheter procedure.
• Heart failure symptoms NYHA functional ≥ II.
• Aortic valve annulus with a mean diameter between 17.3 and 28.6 mm, documented by imaging method, suitable for positioning and accommodation of the Inovare® prosthesis, according to the judgment of an experienced hemodynamicist.
• Height of coronary ostia \> 10 mm or presence of a coronary graft that prevents the occurrence of acute myocardial ischemia due to coronary occlusion after valve release.
• Femoral arterial access route considered adequate for the progression of the vascular introducer and prosthesis-balloon system, typically evaluated through multi-imaging methods that include, for example, conventional angiography and computed tomography.
• Patient has provided written informed consent to participate in the trial.

You may not qualify if:

• Clinic
• Hemodynamic instability requiring vasoactive drugs or circulatory support;
• Valve procedure with clinical need to be performed in a time of urgency or emergency (non-elective);
• Left ventricular ejection fraction \< 30%;
• Chronic renal failure on dialysis or with serum creatinine levels \> 3.0 mg/dL (265 µmol/L);
• Acute renal failure with serum creatinine that has not yet returned to baseline levels;
• Clinical or biological signs of infection with systemic repercussions;
• Endocarditis \< 12 months;
• Coronary artery disease requiring elective revascularization during or after the valve procedure;
• Evidence of myocardial infarction in an interval of less than one month;
• Recent stroke or transient ischemic attack (within the last 6 months);
• Hypersensitivity or contraindication to the administration of heparin, ticlopidine or clopidogrel or to radiopaque contrast;
• Anemia (hemoglobin \< 10 g/dl), thrombocytopenia (\< 100,000 cells/mm3) or hyperthrombocytosis (\> 700,000 cells/mm3);
• Need for chronic anticoagulation for other causes;
• Active peptic disease, gastrointestinal bleeding \< 3 months, or previously diagnosed bleeding diathesis;

Sponsors & Collaborators

• Braile Biomedica Ind. Com. e Repr. Ltda.: lead

Study Sites (4)

Fundação Faculdade Regional de Medicina de São José do Rio Preto

São José do Rio Preto, Brazil

Location

INCOR - Instituto do Coração do Hospital das Clínicas da FMUSP

São Paulo, Brazil

Location

Instituto Dante Pazzanese de Cardiologia

São Paulo, Brazil

Location

Universidade Federal de São Paulo

São Paulo, Brazil

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

• José Honório de Almeida Palma da Fonseca, Dr

  InCor Heart Institute

  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: August 18, 2022
• First Posted: September 8, 2022
• Study Start: September 11, 2020
• Primary Completion: February 20, 2024
• Study Completion (Estimated): December 30, 2028
• Last Updated: January 11, 2024

Record last verified: 2024-01

Locations

BR (4)