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FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System

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: NCT03417011
Recruitment Status : Active, not recruiting
First Posted : January 31, 2018
Last Update Posted : April 29, 2020
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular

Brief Summary:

Prospective, single-arm, multi-center, interventional post-market study. After signing informed consent, eligible subjects will be implanted with the CE marked Evolut™ PRO system.

The investigation purpose is to evaluate the acute and long term clinical performance and safety of Evolut™ PRO in a routine hospital setting in patients with symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement within the approved intended use in local geography.


Condition or disease Intervention/treatment
Aortic Valve Stenosis Device: Medtronic CoreValve™ Evolut™ PRO System (Evolut™ PRO System)

Detailed Description:
Approximately 600 subjects implanted with the Evolut™ PRO at up to 40 sites in Europe. Other regions may be added depending on the regulatory status of the device.

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Study Type : Observational
Actual Enrollment : 638 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System
Actual Study Start Date : February 26, 2018
Actual Primary Completion Date : March 6, 2019
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Medtronic CoreValve™ Evolut™ PRO System (Evolut™ PRO System)
    Transcatheter Aortic Valve Replacement with Medtronic Evolut PRO system


Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 30 days post procedure ]
    The all-cause mortality rate at 30 days post procedure meets a prespecified performance goal of 5.5%.


Secondary Outcome Measures :
  1. Total AR [ Time Frame: 24 hours to 7 days post procedure (prior to discharge) ]
    The percentage of subjects graded as none or trace total aortic regurgitation at discharge is greater than a prespecified performance goal of 67.1%.

  2. VARC-2 composite safety endpoint [ Time Frame: through 5 years from enrollment until end of study ]

    Event rate of the VARC-2 composite safety endpoint through 5 years from enrollment until end of study, which includes the following components:

    • 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 (BAV, TAVI, or SAVR)

  3. Individual components of the VARC-2 composite safety endpoint [ Time Frame: through 5 years from enrollment until end of study ]
    Event rates of the individual components of the VARC-2 composite safety endpoint through 5 years until end of study

  4. Rate of new permanent pacemaker implant [ Time Frame: 30 days post procedure ]
    Rate of new permanent pacemaker implant at 30 days post procedure

  5. Device success rate [ Time Frame: 24 hours to 7 days post procedure (prior to discharge) ]

    Device success rate at 24 hours to 7 days post procedure (prior to discharge), defined according to the VARC-2 guidelines as:

    • Absence of procedural mortality, AND
    • Correct positioning of a single prosthetic heart valve into the proper anatomical location, AND
    • Intended performance of the prosthetic heart valve, defined as the absence of patient prosthesis mismatch and mean gradient <20 mmHg (or peak velocity <3 m/sec), AND
    • No moderate or severe prosthetic valve regurgitation.

  6. Hemodynamic performance [ Time Frame: 24 hours to 7 days (prior to discharge), 1-year, 3-year and 5-year post ]
    Hemodynamic performance at 24 hours to 7 days (prior to discharge), 1-year, 3-year and 5-year post procedure, including the mean prosthetic valve gradient as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory.

  7. Hemodynamic performance [ Time Frame: 24 hours to 7 days (prior to discharge), 1-year, 3-year and 5-year post ]
    Hemodynamic performance at 24 hours to 7 days (prior to discharge), 1-year, 3-year and 5-year post procedure, including the effective orifice area as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory.

  8. Hemodynamic performance [ Time Frame: 24 hours to 7 days (prior to discharge), 1-year, 3-year and 5-year post ]
    Hemodynamic performance at 24 hours to 7 days (prior to discharge), 1-year, 3-year and 5-year post procedure, including the degree of prosthetic valve regurgitation (transvalvular, paravalvular and total) as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory.

  9. Change in NYHA functional status [ Time Frame: From baseline to 30-day, 1-year, 3-year, and 5-year post procedure ]
    Change in NYHA functional status from baseline to 30-day, 1-year, 3-year, and 5-year post procedure

  10. Change in Quality of Life score [ Time Frame: From baseline to 30-day, and 1-year, 3-year, and 5-year post procedure ]
    Change in Quality of Life score (EQ-5D questionnaire) from baseline to 30-day, and 1-year, 3-year, and 5-year post procedure. The EQ-5D descriptive system comprises five dimensions and each dimension has five levels of severity. The subject is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the five dimensions. The EQ VAS records the subject's self-rated health on a 20 cm vertical, visual analogue scale. The subject marks an X on the scale to indicate how his/her health is TODAY and then writes the number they marked on the scale in the box below.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement within the approved intended use in local geography.
Criteria

Inclusion Criteria:

  • Symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement
  • High or greater risk for surgical aortic valve replacement as estimated by the heart team OR, 75 years or older and at intermediate risk for surgical AVR (STS risk score ≥4% or with an estimated hospital mortality ≥4% as assessed by the heart team)
  • Acceptable candidate for treatment with the Evolut™ PRO system in conformity with the Instructions for Use and the local regulations
  • Able and willing to return to the implanting site at the following follow-up visits: 1-year, 3-year and 5-year
  • Written informed consent obtained without assistance from a legal representative prior to enrollment in the study.

Exclusion Criteria:

  • Known hypersensitivity or contraindication to aspirin, heparin (HIT/HITTS) and bivalirudin, ticlopidine, clopidogrel, Nitinol (Titanium or Nickel), or sensitivity to contrast media, which cannot be adequately premedicated
  • Preexisting mechanical heart valve in aortic position
  • Ongoing sepsis, including active endocarditis
  • Anatomically not suitable for the Evolut™ PRO system
  • Estimated life expectancy of less than 1 year
  • Participating in another trial that may influence the outcome of this study
  • Need for emergency surgery for any reason
  • Inability to understand and respond to the quality of life questionnaire

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): NCT03417011


Locations
Show Show 39 study locations
Sponsors and Collaborators
Medtronic Cardiovascular
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Responsible Party: Medtronic Cardiovascular
ClinicalTrials.gov Identifier: NCT03417011    
Other Study ID Numbers: MDT17050EVR003
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020
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
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction