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NVT ALLEGRA TAVI System TF in Failing Calcified Aortic Heart Valves in a Real-world Patient Population (FOLLOW)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03613246
Recruitment Status : Recruiting
First Posted : August 3, 2018
Last Update Posted : March 5, 2021
Sponsor:
Information provided by (Responsible Party):
NVT GmbH

Study Description
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Brief Summary:
The study collects real-world data of patients who were treated with the ALLEGRA TAVI System TF and evaluates early and midterm clinical and quality of life outcome.

Condition or disease
Transcatheter Aortic Valve Implantation

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Clinical Outcomes of the NVT ALLEGRA TAVI System TF in Failing Calcified Aortic Heart Valves in a Real-world Patient Population With Elevated Surgical Risk
Actual Study Start Date : February 20, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Cardiovascular death [ Time Frame: 30 days post-index procedure ]

Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: up to two years ]
  2. Technical success of implantation [ Time Frame: day of procedure ]

    Technical success of implantation, as defined by:

    • absence of procedural mortality AND
    • correct positioning of a single prosthetic heart valve into the proper anatomical location AND
    • no prosthesis - patient mismatch AND
    • mean aortic valve gradient <20 mmHg, AND
    • no moderate or severe prosthetic valve regurgitation

  3. Assesment of NYHA classification [ Time Frame: 30 days, 12 month, 24 month ]
  4. Safety profile according to VARC II [ Time Frame: 30 days ]

    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

    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
    • Prosthetic valve endocarditis
    • Prosthetic valve thrombosis
    • Thrombo-embolic events (e.g. stroke)
    • VARC bleeding, unless clearly unrelated to valve therapy

  5. In-hospital mortality [ Time Frame: date of procedure till date of estimated discharge, assessed up to two weeks ]
  6. Quality of life (EQ5D 5L) [ Time Frame: 30 days, 12 month, 24 month ]
  7. New pacemaker implantation [ Time Frame: up to two years ]
  8. assessment of mean aortic gradient post-implantation [ Time Frame: up to two years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Symptomatic patients with elevated surgical risk and candidate for TAVI with severe calcified and stenotic aortic valves or failing surgical bioprosthetic aortic valves.
Criteria

Inclusion Criteria:

  1. Symptomatic degeneration of severe calcified aortic heart valve OR failing surgical aortic bioprosthetic valve
  2. Acceptable candidate for elective treatment with the ALLEGRA TAVI System TF (according to the most recent version of the ALLEGRA Instructions For Use)
  3. High risk for surgery as assessed by the heart team
  4. Has signed the Patient Informed Consent Form >= 18 years

Exclusion Criteria:

General:

  1. Echocardiographic evidence of intracardiac thrombus or vegetation
  2. 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
  3. 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
  4. Severe ventricular dysfunction with LVEF <20%
  5. Evidence of active endocarditis or other acute infections
  6. Renal failure requiring continuous renal replacement therapy
  7. 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
  8. Life expectancy ≤ 12 months due to other medical illness
  9. Currently participating in another investigational drug or device study

Patients with native aortic valve disease:

  1. Unicuspid or bicuspid aortic valve
  2. Non-calcified aortic stenosis
  3. Combined aortic valve disease with predominant aortic regurgitation > 3
  4. Distance between aortic valve basal plane and the orifice of the lowest coronary artery < 8 mm

Patients with degenerated surgical bioprosthetic aortic valves:

  1. Low position of the coronary ostia, especially in combination with shallow sinuses
  2. Internal diameter of the bioprosthesis is ≤16 mm or >28 mm
  3. Partially detached leaflets that in the aortic position may obstruct a coronary ostium
Contacts and Locations
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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): NCT03613246


Contacts
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Contact: Martin Faiss, PhD +49 7471 98979 ext 230 martin.faiss@nvt-med.com

Locations
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Finland
Oulu University Hospital Recruiting
Oulu, Finland, 90220
Contact: Jarkko Piuhola, MD         
Germany
Herz- und Gefäßzentrum Bad Bevensen Recruiting
Bad Bevensen, Germany, 29549
Contact: Christof Burgdorf, MD         
Kath. Marienkrankenhaus Recruiting
Hamburg, Germany, 22087
Contact: Ulrich Schäfer, MD         
MH Hannover Recruiting
Hannover, Germany, 30625
Contact: Julian Widder, MD         
SLK-Kliniken Heilbronn Active, not recruiting
Heilbronn, Germany, 74078
Italy
Ospedale San Raffaele Recruiting
Milan, Italy, 20132
Contact: Matteo Montorfano, MD         
Netherlands
Heartcentre Catharina Hospital Eindhoven Recruiting
Eindhoven, Netherlands, 5623 EJ
Contact: Pim Tonino, MD         
Spain
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Contact: Raul Moreno, MD         
Hospital Alvaro Cunqueiro Recruiting
Vigo, Spain, 36213
Contact: Andres Iñiguez, MD         
Sponsors and Collaborators
NVT GmbH
Investigators
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Principal Investigator: Ulrich Schäfer, MD Kath. Marienkrankenhaus Hamburg, Germany
More Information
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Responsible Party: NVT GmbH
ClinicalTrials.gov Identifier: NCT03613246    
Other Study ID Numbers: NVT04FOL
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: March 5, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
TAVI
Aortic valve stenosis
ALLEGRA