NVT ALLEGRA TAVI System TF in Failing Surgical Aortic Bioprosthesis

Transcatheter Aortic Valve Implantation Clinical Trial

— VIVALL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03287856
• Other study ID #: NVT03VIV
• Status: Completed
• Phase: N/A
• Start date: August 11, 2017
• Est. completion date: October 27, 2019

Study information

• Verified date: January 2020
• Source: NVT GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 27, 2019
• Est. primary completion date: September 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Transcatheter Aortic Valve Implantation

Intervention

Device:
• Transcatheter Aortic Valve Implantation (TAVI)
Implantation of the ALLEGRA Transcatheter Heart Valve in failing surgical bioprosthesis

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
NVT GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Schäfer 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 st — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean pressure gradient		immediately after index-procedure
Primary	30-days survival	Proportion of participants with overall survival at 30 days	30 days
Secondary	Cardiovascular mortality		30 days
Secondary	Hemodynamic parameters	pressure gradient, effective orifice area, velocity	up to12 months
Secondary	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
Secondary	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
Secondary	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	up to 12 months
Secondary	New Pacemaker implantation	Proportion of patients with pacemaker implantations after index-procedure	up to 12 months
Secondary	NYHA classification		up to 12 months

External Links

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