NVT ALLEGRA TAVI System TF in Failing Surgical Aortic Bioprosthesis

NCT03287856 | Completed DMC

• 1 other identifier: NVT03VIV
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

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

Conditions

Transcatheter Aortic Valve Implantation

Keywords

Valve-in-valve; TAVI

Outcome Measures

Primary Outcomes (2)

• Mean pressure gradient

  immediately after index-procedure

• 30-days survival

  Proportion of participants with overall survival at 30 days

  30 days

Secondary Outcomes (7)

• Cardiovascular mortality

  30 days

• Hemodynamic parameters

  up to12 months

• Technical success of implantation

  immediately after index-procedure

• Early safety

  30 days

• Time related valve safety

  up to 12 months

Study Arms (1)

Treatment

EXPERIMENTAL

Transcatheter Aortic Valve Implantation (TAVI) in failing surgical bioprosthesis

Device: Transcatheter Aortic Valve Implantation (TAVI)

Interventions

Transcatheter Aortic Valve Implantation (TAVI) DEVICE

Implantation of the ALLEGRA Transcatheter Heart Valve in failing surgical bioprosthesis

Treatment

Eligibility Criteria

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

You may qualify if:

• ≥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

You may not qualify if:

• 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)

Sponsors & Collaborators

• NVT GmbH: lead

Study Sites (5)

Segeberger Kliniken, Herzzentrum

Bad Segeberg, Germany

Location

Immanuel Klinik Bernau Herzzentrum Brandenburg

Bernau bei Berlin, Germany

Location

Mitteldeutsches Herzzentrum Universitätsklinikum Halle (Saale)

Halle, Germany

Location

Asklepios Klinik St. Georg

Hamburg, Germany

Location

Universitäres Herzzentrum Hamburg GmbH

Hamburg, Germany

Location

Related Publications (1)

• 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.

  PMID: 31355750 RESULT

Related Links

• Related Info

MeSH Terms

Interventions

Transcatheter Aortic Valve Replacement

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Ulrich Schaefer, MD

  Universitäres Herzzentrum Hamburg, Germany

  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 15, 2017
• First Posted: September 19, 2017
• Study Start: August 11, 2017
• Primary Completion: September 27, 2018
• Study Completion: October 27, 2019
• Last Updated: January 10, 2020

Record last verified: 2020-01

Locations

DE (5)