Aortic Valve StenosisNCT05531578

Transfemoral Implant of Inovare® Transcatheter Valve

A study testing INOVARE® Transcatheter Valve, NexusCath Delivery System, Aureus Expandable Introducer, Balloon Catheter for Pre-Dilation and Compression Device (Crimper) in people with Aortic Valve Stenosis, run by Braile Biomedica Ind. Com. e Repr. Ltda. at 4 sites in Brazil.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Aortic Valve Stenosis
What is being tested?: INOVARE® Transcatheter Valve, NexusCath Delivery System, Aureus Expandable Introducer, Balloon Catheter for Pre-Dilation and Compression Device (Crimper)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 4 sitesBrazil
Study dates: 11 Sep 2020to 30 Dec 2028
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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;

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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;
Life expectancy less than 12 months due to non-cardiac disease or other comorbidities.
Anatomical/morphological
Valve ring diameter less than or equal to 17.2 mm or greater than or equal to 28.7 mm;
Iliofemoral access route, with extreme tortuosity or calcification or reduced luminal diameter (typically < 7 mm), which prevents safe progression of the arterial introducer and delivery system with the prosthesis, according to the judgment of the responsible physician;
Presence of sessile and unstable atheromas in the ascending aorta and/or aortic arch detected by imaging methods;
Obstructive hypertrophic cardiomyopathy or severe left ventricular outflow tract obstruction, with no possibility of balloon dilation;
Previous aortic or mitral valve procedure (surgical or by catheter, excluding aortic balloon valvuloplasty);
Moderate or severe aortic, mitral or tricuspid regurgitation;
Non-calcified native valve;
Evidence of an intracardiac mass (tumor, thrombus, or vegetation).

Trial locations and contacts

4 sites in 1 country.

Brazil4 sites

Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto
INCOR - Instituto do Coração do Hospital das Clínicas da FMUSP
São Paulo
Instituto Dante Pazzanese de Cardiologia
São Paulo
Universidade Federal de São Paulo
São Paulo

Other trials in Brazil

About this study

Official title: Transfemoral Implant of Inovare® Transcatheter Valve - Clinical Trial of Feasibility and Safety and Efficacy Verification

Read the detailed description

The Inovare® transcatheter valve was developed and has been market ed since 2011 for replacement, via transapical or transaortic route, of calcified native aortic valves and degenerated bioprostheses (aortic and mitral) with satisfactory medium-long-term results. The present study aims to evaluate the safety and clinical performance of the new navigation and delivery system of this device using the transfemoral route. The new device has as its main feature the drivable control of the curvature of the delivery system, the which allows better navigability in regions of more complex anatomy, especially with accentuated tortuosities.

Conditions: Aortic Valve Stenosis
Being tested: INOVARE® Transcatheter Valve, NexusCath Delivery System, Aureus Expandable Introducer, Balloon Catheter for Pre-Dilation and Compression Device (Crimper)
Keywords: TAVI, TAVR, Transfemoral, Transcatheter Valve
Medical subject headings: Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05531578
Study group	Role	What they receive
TAVI TRANSFEMORAL	Experimental	Not described Receives: Device: INOVARE® Transcatheter Valve, NexusCath Delivery System, Aureus Expandable Introducer, Balloon Catheter for Pre-Dilation and Compression Device (Crimper)

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: 30 days

Secondary outcomes (3)

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).
Measured: 30 days or more
Incidence of serious adverse events
Overall mortality; · Coronary obstruction requiring percutaneous intervention (PCI); · Stroke; · Stage 2-3 acute kidney injury requiring dialysis technique or increase in creatinine ≥ 300% or creatinine ≥4.0 mg/dl; · Life-threatening bleeding (or sequelae) or critical organ bleeding or hypovolemic shock or severe hypotension requiring vasopressors or surgery or packed red blood cells (RBCs) transfusion ≥4 units; · Major vascular complication; · Reintervention for valvular dysfunction; · Myocardial infarction; ·Permanent pacemaker implantation
Measured: 30 days or more
Efficacy of the procedure
Mortality, stroke, bioprosthesis dysfunction due to stenosis (mean gradient ≥ 20 mmHg) and regurgitation ≥ moderate, re-hospitalization with congestive heart failure or valvular symptoms, New York Heart Association (NYHA) functional class III or IV.
Measured: 30 days or more

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Sep 202030 Dec 2028

First posted8 Sep 2022
Study start11 Sep 2020
Primary completion20 Feb 2024 (estimated)
Study completion30 Dec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05531578
Sponsor's protocol ID: Inovare - Transfemoral
Status last verified: Jan 2024
First submitted: 18 Aug 2022
Last updated: 11 Jan 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic

All Aortic Valve Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Transfemoral Implant of Inovare® Transcatheter Valve - Clinical Trial of Feasibility and Safety and Efficacy Verification
ClinicalTrials.gov ID: NCT05531578
Acronym / sponsor ID: Inovare - Transfemoral
Conditions: Aortic Valve Stenosis
Keywords: TAVI, TAVR, Transfemoral, Transcatheter Valve
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 60 participants (actual)
Lead sponsor: Braile Biomedica Ind. Com. e Repr. Ltda.Industry (pharma, biotech, devices)
Study start: 11 Sep 2020 (actual)
Primary completion: 20 Feb 2024 (estimated)
Study completion: 30 Dec 2028 (estimated)
First posted: 8 Sep 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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:
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.

Key exclusion criteria (25 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
INOVARE® Transcatheter Valve, NexusCath Delivery System, Aureus Expandable Introducer, Balloon Catheter for Pre-Dilation and Compression Device (Crimper)Transfemoral implantation of the INOVARE® transcatheter valve	Device	TAVI TRANSFEMORAL

Primary outcome

Device success
Time frame: Procedure
Absence of mortality in the procedure AND correct positioning of a single bioprosthesis with the intended performance (mean gradient < 20 mmHg and regurgitation ≥ moderate).
Death the first 30 days
Time frame: 30 days
Deaths from any cause within the first 30 days of the procedure or during hospital stay will be considered procedure-related deaths.

3 secondary outcomes

Device success
Time frame: 30 days or more
Incidence of serious adverse events
Time frame: 30 days or more
Efficacy of the procedure
Time frame: 30 days or more

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.

Related trials for Aortic Valve Stenosis

Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

José Honório de Almeida Palma da Fonseca, Dr principal investigator

InCor Heart Institute

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Device success (time frame: Procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05531578.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.