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NVT ALLEGRA TAVI System TF in Failing Surgical Aortic Bioprosthesis (VIVALL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03287856
Recruitment Status : Active, not recruiting
First Posted : September 19, 2017
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
NVT GmbH

Brief 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

Condition or disease Intervention/treatment Phase
Transcatheter Aortic Valve Implantation Device: Transcatheter Aortic Valve Implantation (TAVI) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 11, 2017
Actual Primary Completion Date : September 27, 2018
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment
Transcatheter Aortic Valve Implantation (TAVI) in failing surgical bioprosthesis
Device: Transcatheter Aortic Valve Implantation (TAVI)
Implantation of the ALLEGRA Transcatheter Heart Valve in failing surgical bioprosthesis




Primary Outcome Measures :
  1. Mean pressure gradient [ Time Frame: immediately after index-procedure ]
  2. 30-days survival [ Time Frame: 30 days ]
    Proportion of participants with overall survival at 30 days


Secondary Outcome Measures :
  1. Cardiovascular mortality [ Time Frame: 30 days ]
  2. Hemodynamic parameters [ Time Frame: up to12 months ]
    pressure gradient, effective orifice area, velocity

  3. Technical success of implantation [ Time Frame: immediately after index-procedure ]
    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

  4. Early safety [ Time Frame: 30 days ]
    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

  5. Time related valve safety [ Time Frame: up to 12 months ]

    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

  6. New Pacemaker implantation [ Time Frame: up to 12 months ]
    Proportion of patients with pacemaker implantations after index-procedure

  7. NYHA classification [ Time Frame: up to 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03287856


Locations
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Germany
Universitäts-Herzzentrum Freiburg-Bad Krozingen
Bad Krozingen, Germany
Segeberger Kliniken, Herzzentrum
Bad Segeberg, Germany
Immanuel Klinik Bernau Herzzentrum Brandenburg
Bernau bei Berlin, Germany
Mitteldeutsches Herzzentrum Universitätsklinikum Halle (Saale)
Halle (Saale), Germany
Asklepios Klinik St. Georg
Hamburg, Germany
Universitäres Herzzentrum Hamburg GmbH
Hamburg, Germany
Herzzentrum Leipzig GmbH Universitätsklinik
Leipzig, Germany
Klinikum Oldenburg AöR
Oldenburg, Germany
Sponsors and Collaborators
NVT GmbH
Investigators
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Principal Investigator: Ulrich Schaefer, MD Universitäres Herzzentrum Hamburg, Germany

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Responsible Party: NVT GmbH
ClinicalTrials.gov Identifier: NCT03287856     History of Changes
Other Study ID Numbers: NVT03VIV
First Posted: September 19, 2017    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NVT GmbH:
Valve-in-valve
TAVI
Additional relevant MeSH terms:
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Fexofenadine
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs