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

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

Study Overview

• Status: Completed
• Conditions: Transcatheter Aortic Valve Implantation
• Intervention / Treatment: Device: Transcatheter Aortic Valve Implantation (TAVI)

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bad Segeberg, Germany
    • Segeberger Kliniken, Herzzentrum
  • Bernau bei Berlin, Germany
    • Immanuel Klinik Bernau Herzzentrum Brandenburg
  • Halle (Saale), Germany
    • Mitteldeutsches Herzzentrum Universitätsklinikum Halle (Saale)
  • Hamburg, Germany
    • Asklepios Klinik St. Georg
  • Hamburg, Germany
    • Universitäres Herzzentrum Hamburg GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean pressure gradient		immediately after index-procedure
30-days survival	Proportion of participants with overall survival at 30 days	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular mortality		30 days
Hemodynamic parameters	pressure gradient, effective orifice area, velocity	up to12 months
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	immediately after index-procedure
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	30 days
Time related valve safety	structural valve deterioration as defined by; requiring repeat procedure (transcatheter or surgical heart valve replacement); valve-related dysfunction defined bymean aortic valve gradient ≥20 mmHg ANDno moderate or severe prosthetic valve regurgitation	up to 12 months
New Pacemaker implantation	Proportion of patients with pacemaker implantations after index-procedure	up to 12 months
NYHA classification		up to 12 months

Collaborators and Investigators

• Sponsor: NVT GmbH
• Investigators: Principal Investigator: Ulrich Schaefer, MD, Universitäres Herzzentrum Hamburg, Germany

Publications and helpful links

General 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2017
• Primary Completion (Actual): September 27, 2018
• Study Completion (Actual): October 27, 2019

Study Registration Dates

• First Submitted: August 15, 2017
• First Submitted That Met QC Criteria: September 15, 2017
• First Posted (Actual): September 19, 2017

Study Record Updates

• Last Update Posted (Actual): January 10, 2020
• Last Update Submitted That Met QC Criteria: January 7, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: TAVI; Valve-in-valve
• Other Study ID Numbers: NVT03VIV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No