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Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement (PERSIST-AVR)

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ClinicalTrials.gov Identifier: NCT02673697
Recruitment Status : Active, not recruiting
First Posted : February 4, 2016
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
LivaNova

Brief Summary:

Prospective, randomized, stratified non blinded multi-center, international, post market trial assessed in a non-inferiority study.

A minimum of 1234 subjects will be enrolled at approximately 60 worldwide investigational sites where the device is commercially available.

The primary objective of this trial is to test the safety and efficacy of Perceval versus standard sutured stented bioprosthetic aortic valves among the intended trial population.


Condition or disease Intervention/treatment Phase
Aortic Valve Disease Aortic Stenosis Device: Perceval valve Device: other stented biological valve Not Applicable

Detailed Description:
PERSIST-AVR is designed to collect data on sutureless valve (Perceval sutureless aortic heart valve), a new type of biological aortic valve, comparing data with standard biological aortic valve, considered the gold standard for aortic valve replacement. This prospective, randomized international multicenter study is planned to demonstrate, as primary endpoint, the non inferiority of Major Adverse Cardiac and Cerebrovascular (MACCE) events at one year while showing superiority in resource consumptions at hospital discharge in patients treated with Perceval valve when compared to standard aortic valve replacement. The study is planned to cover the lack of prospective, randomized comparison data between sutureless valve and standard aortic biological sutured valve. To achieve the primary endpoint, 1234 patients will be recruited in 60 worldwide investigational sites. The be part of the trial, investigational sites should have demonstrated experience with the implantation of the Perceval and able to implement the requirements of the study protocol.. All subjects with severe symptomatic aortic stenosis or steno-insufficiency who are candidates for surgical replacement of their native aortic valve according to established guidelines in current medical practice and as specified in the Perceval valve Instruction for Use (IFU) are the intended population for inclusion in this randomized trial. The patients will be followed for 5 years after the implant, the total duration of study including the enrollment time will be 7 years

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1234 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement A Controlled Randomized Trial in the Surgical Treatment of Aortic Valve Disease
Actual Study Start Date : March 22, 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Perceval
The Perceval sutureless aortic heart valve (Perceval valve) is a bioprosthesis manufactured with bovine pericardium and assembled on a Nitinol stent. The Perceval valve is designed to offer an alternative to surgically implanted flexible prostheses (stented and stentless biological valves). A special feature of the device is that it is self-anchoring and does not require sutures to be fixed to the implant site.
Device: Perceval valve
Sutureless Aortic Biological Valve

Active Comparator: other Stented biological valves
The comparator will be other commercially approved standard biological sutured stented valves, both bovine and porcine. The choice of the comparator tissue valve will be at the discretion of the participating investigators.
Device: other stented biological valve
Any biological stented valves available on the market (Edwards, Medtronic, St.Jude, LivaNova, Labcor)




Primary Outcome Measures :
  1. Freedom from MACCE [ Time Frame: 1 year post-operatively ]
    The primary endpoint is freedom from MACCE (composite endpoint of all cause death, myocardial infarction, stroke, and valve re-intervention) at one year based on Clinical Event Committee (CEC) adjudication.


Secondary Outcome Measures :
  1. Surgical times [ Time Frame: Intra-operative ]
    1. Cross clamp time during index procedure
    2. Cardiopulmonary bypass time during index procedure

  2. Normalized Consumption Index [ Time Frame: Hospital Discharge (average 10 days) ]

    Normalized Consumption Index including resource consumption items such as (but not limited to):

    1. Operative room time,
    2. Duration of ICU and total hospital stay
    3. Incidence of specific serious adverse events as defined in Appendix 3
    4. Blood transfusion

  3. Reduced Normalized Consumption Index [ Time Frame: Hospital Discharge (average 10 days) ]

    Reduced Normalized Consumption Index, including resource consumption items such as (but not limited to):

    1. Operative room time,
    2. Duration of ICU and total hospital stay
    3. Incidence of specific serious adverse events as defined in Appendix 3
    4. Blood transfusion

  4. Quality of life questionnaire [ Time Frame: At 1 month and 1 year post surgery ]
    Questionnaire for quality of life (EQ5D)

  5. Intraprocedural and periprocedural serious adverse events regardless of relationship with the device [ Time Frame: 72 hours post surgery ]
  6. All valve and procedure relevant serious adverse events as specified in Valve Academic Research Consortium-2 (VARC-2) guidelines [ Time Frame: At 30 days and annually up to 5 years post surgery ]
    1. Early safety at 30 days
    2. Clinical efficacy after 30 days
    3. Time related valve safety: [Structural Valve Deterioration (SVD), endocarditis, Thrombosis, Thromboembolic events (excluding stroke), and bleeding] annually up to 5 years

  7. Serious device related adverse events [ Time Frame: Up to 5 years post surgery ]
  8. Freedom from MACCE [ Time Frame: At 2, 3, 4 and 5 years post surgery ]
  9. Rate of Pacemaker implantation [ Time Frame: Up to 1 year post surgery ]
    The rate of pacemaker implantation during the first year post surgery will be analyzed

  10. Echocardiographic endpoints (site-reported data) [ Time Frame: Preoperatively, at hospital discharge (average 10 days), between 1-3 month, 1 year, 3 year and 5 years post surgery ]
    Performance of the valve in terms of hemodynamic behavior

  11. Echocardiographic endpoints in a reduced cohort of patients assessed by core lab [ Time Frame: Preoperatively, at hospital discharge (average 10 days), between 1-3 month, 1 year, 3 year and 5 years post surgery ]
    Performance of the valve in terms of hemodynamic behavior.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The subject has an indication for treatment by valve replacement with a bioprosthesis according to the IFU, through either full sternotomy or mini-sternotomy.
  2. The subject has aortic valve disease that can be treated with a commercially available Perceval valve size, based on preoperative CT-scan.
  3. The subject has:

    1. critical aortic valve area defined as an initial aortic valve area of ≤1.0 cm2 or aortic valve area index < 0.6 cm2/m2 AND
    2. Mean gradient > 40 mmHg or Vmax > 4 m/sec by resting echocardiogram or simultaneous pressure recordings at cardiac catheterization [or with dobutamine stress, if subject has a left ventricular ejection fraction (LVEF) <55%] or velocity ratio < 0.25;
  4. The subject is symptomatic due to aortic stenosis with functional class of New York Heart Association (NYHA) II or higher.
  5. The subject has signed the informed consent.
  6. The subject is of legal minimum age.
  7. The subject will be available for postoperative follow-up beyond one year.

Exclusion Criteria:

  1. The subject has a contraindication for treatment by the Perceval valve or by a bioprosthetic aortic valve as stated in the IFU.
  2. The subject has aneurismal dilation or dissection of the ascending aortic wall.
  3. The subject is scheduled for concomitant procedures other than Coronary Aortic Bypass Graft (CABG), myectomy with or without aortic annulus enlargement
  4. The subject has congenital bicuspid (i.e. Sievers type 0) or unicuspid aortic valve.
  5. Anatomical structures not suitable for Perceval valve such as: aortic root enlargement, where the ratio between the diameter of the sino-tubular junction and the annulus diameter is > 1.3.
  6. The subject has a prosthetic heart valve in any position, including mitral valve repair.
  7. The subject has a stroke or myocardial infarction (STEMI and NSTEMI) within 30 days prior to the planned valve implant surgery.
  8. The subject has active endocarditis, myocarditis, or sepsis.
  9. The subject is in cardiogenic shock manifested by low cardiac output and needing hemodynamic support.
  10. The subject is allergic to nickel alloys.
  11. The subject is already included in another clinical trial that could confound the results of this clinical investigation.

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): NCT02673697


  Show 43 Study Locations
Sponsors and Collaborators
LivaNova
Investigators
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Principal Investigator: Theodor Fischlein, MD Klinikum Nurnberg, Nurnberg, Germany
Principal Investigator: Roberto Lorusso, MD, PhD Maastricht University Medical Center

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Responsible Party: LivaNova
ClinicalTrials.gov Identifier: NCT02673697     History of Changes
Other Study ID Numbers: TPS003
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by LivaNova:
Sutureless valve
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Defects, Congenital
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Cardiovascular Abnormalities
Congenital Abnormalities