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Transcatheter Aortic Valve ImplantationVIVALLNCT03287856

NVT ALLEGRA TAVI System TF in Failing Surgical Aortic Bioprosthesis

A study testing Transcatheter Aortic Valve Implantation (TAVI) in people with Transcatheter Aortic Valve Implantation, run by NVT GmbH at 5 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study investigates the technical feasibility of the replacement of failed surgical bioprosthetic aortic valves by the ALLEGRA Transcatheter Heart Valve (THV) and describes the safety and performance profile Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Transcatheter Aortic Valve Implantation
What is being tested?
Transcatheter Aortic Valve Implantation (TAVI)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
5 sitesGermany
Study dates
11 Aug 2017to 27 Oct 2019
Phase
Interventional
Are there results?
None posted in the registry

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

  • ≥18 years
  • Symptomatic degeneration of aortic bioprosthesis showing echocardiographically mean aortic gradient >40mmHg or peak jet velocity >4.0m/s and AVA<1.0cm2 OR symptomatic patients with severe bioprosthetic valve insufficiency.
  • High risk for redo surgery defined by STS ≥10% / EuroScore II ≥7% OR as assessed by the heart team
  • Has signed the Patient Informed Consent Form
  • Willing and able to comply with requirements of the study, including all follow-up visits
  • Female patients of childbearing potential have a negative pregnancy test ≤7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation

Who cannot join

  • Low position of the coronary ostia, especially in combination with shallow sinuses
  • Echocardiographic evidence of intracardiac mass, thrombus or vegetation
  • Significant aortic disease such as severe obstructive calcification or marked tortuosity or kinking which will preclude a safe advancement of the ALLEGRA TAVI System TF
  • Iliofemoral vessel conditions such as severe obstructive calcification, severe tortuosity or kinking that would preclude safe placement of an 18 Fr introducer sheath or make endovascular access to the aortic valve impossible
  • Severe mitral insufficiency
  • Internal diameter of the bioprosthesis is ≤16 mm or >28 mm
Show all 25Show fewer
  • Patient prosthesis mismatch (EOAi ≤0.65 cm2/m2) as the underlying cause of the poor valve function and need for re-intervention
  • Non-valvular stenosis as the underlying cause of the poor valve function and need for re-intervention
  • Failing pre-existing prosthetic heart valve or prosthetic ring in any other position than aortic
  • Partially detached leaflets that in the aortic position may obstruct a coronary ostium.
  • Existence of aortic conduit, aortic arch replacement, stentless bioprosthesis and autologous valve replacement
  • Paravalvular leak of the failing surgical bioprosthesis (between failing surgical bioprosthesis and native annulus)
  • LVEF <20%
  • Evidence of active endocarditis or other acute infections
  • End stage renal disease requiring chronic dialysis or creatinine clearance <20 ml/min or serum creatinine >3.0 mg/dl (264 µmol/l)
  • Known hypersensitivity to contrast media, which cannot be adequately pre-medicated or contraindication to anticoagulant or anti-platelet medication or to Nitinol alloy or to bovine tissue
  • Evidence of an acute myocardial infarction within the past 30 days
  • Cerebral vascular accident (TIA, Stroke) within past 6 months (≤180 days)
  • Evidence of active peptic ulcer or upper gastrointestinal bleeding within past 90 days
  • Untreated clinically significant coronary artery disease requiring revascularization
  • Hemodynamic instability (e.g. cardiogenic shock) requiring inotropic support or mechanical heart assistance (e.g. VAD, IABP)
  • Uncontrolled (therapy resistant) atrial fibrillation
  • Need for emergency surgery for any reason
  • Life expectancy ≤ 12 months due to other medical illness
  • Currently participating in another investigational drug or device study

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Germany5 sites

  • Segeberger Kliniken, Herzzentrum

    Bad Segeberg

  • Immanuel Klinik Bernau Herzzentrum Brandenburg

    Bernau bei Berlin

  • Mitteldeutsches Herzzentrum Universitätsklinikum Halle (Saale)

    Halle

  • Asklepios Klinik St. Georg

    Hamburg

  • Universitäres Herzzentrum Hamburg GmbH

    Hamburg

Other trials in Germany

About this study

Official title: Investigation of the Safety and Performance of the NVT ALLEGRA TAVI System TF in Patients With Failed Surgical Aortic Bioprosthesis and Elevated Surgical Risk

The study investigates the technical feasibility of the replacement of failed surgical bioprosthetic aortic valves by the ALLEGRA Transcatheter Heart Valve (THV) and describes the safety and performance profile

Being tested
Transcatheter Aortic Valve Implantation (TAVI)
Keywords
Valve-in-valve, TAVI

What participants receive

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

  • Transcatheter Aortic Valve Implantation (TAVI)Device

    Implantation of the ALLEGRA Transcatheter Heart Valve in failing surgical bioprosthesis

Study groups in NCT03287856
Study groupRoleWhat they receive
TreatmentExperimentalTranscatheter Aortic Valve Implantation (TAVI) in failing surgical bioprosthesis
Receives: Device: Transcatheter Aortic Valve Implantation (TAVI)

What is being measured

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

  1. Mean pressure gradient

    Measured: immediately after index-procedure

  2. 30-days survival

    Proportion of participants with overall survival at 30 days

    Measured: 30 days

Secondary outcomes (7)

  1. Cardiovascular mortality

    Measured: 30 days

  2. Hemodynamic parameters

    pressure gradient, effective orifice area, velocity

    Measured: up to12 months

  3. Technical success of implantation

    defined as absence of procedural mortality AND correct positioning of a single prosthetic heart valve into the proper anatomical location AND no severe (<0.65 cm2/m2) prosthesis - patient mismatch AND mean aortic valve gradient <20 mmHg AND no moderate or severe prosthetic valve regurgitation

    Measured: immediately after index-procedure

  4. Early safety

    all-cause mortality, all stroke (disabling and non-disabling), life-threatening bleeding, acute kidney injury stage 2 or 3 (including renal replacement therapy), coronary artery obstruction requiring Intervention, major vascular complication, valve-related dysfunction requiring repeat procedure

    Measured: 30 days

  5. Time related valve safety

    structural valve deterioration as defined by

    • requiring repeat procedure (transcatheter or surgical heart valve replacement)
    • valve-related dysfunction defined by
    • mean aortic valve gradient ≥20 mmHg AND
    • no moderate or severe prosthetic valve regurgitation

    Measured: up to 12 months

  6. New Pacemaker implantation

    Proportion of patients with pacemaker implantations after index-procedure

    Measured: up to 12 months

  7. NYHA classification

    Measured: up to 12 months

Timeline

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

  1. First posted19 Sep 2017
  2. Study start11 Aug 2017
  3. Primary completion27 Sep 2018
  4. Study completion27 Oct 2019

Resources

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
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03287856
Sponsor's protocol ID
NVT03VIV
Acronym
VIVALL
Status last verified
Jan 2020
First submitted
15 Aug 2017
Last updated
10 Jan 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Schafer U, Butter C, Landt M, Frerker C, Treede H, Schirmer J, Koban C, Allali A, Schmidt T, Charitos E, Conradi L. Thirty-day outcomes of a novel transcatheter heart valve to treat degenerated surgical valves: the VIVALL multicentre, single-arm, pilot study. EuroIntervention. 2019 Oct 4;15(9):e757-e763. doi: 10.4244/EIJ-D-19-00331.

    PubMed 31355750

Questions about this trial

What is this clinical trial studying?

A study testing Transcatheter Aortic Valve Implantation (TAVI) in people with Transcatheter Aortic Valve Implantation, run by NVT GmbH at 5 sites in Germany.

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 6 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: finished, as of the sponsor's last update on 10 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Mean pressure gradient (time frame: immediately after index-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 NCT03287856, which also lists 1 linked publication.

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 10 Jan 2020.

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