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Safety and Effectiveness Study of Perceval S Valve for Extended CE Mark (CAVALIER)

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: NCT01368666
Recruitment Status : Terminated (5 years follow up completed in October 2018, long-term follow up terminated because of low data return)
First Posted : June 8, 2011
Last Update Posted : July 8, 2022
Sponsor:
Information provided by (Responsible Party):
Corcym S.r.l

Brief Summary:
The primary objective of this clinical investigation is to assess the safety and effectiveness of the Perceval S valve at 12 months after implantation when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.

Condition or disease Intervention/treatment Phase
Aortic Valve Replacement Device: Perceval S Valve Prosthesis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 658 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Perceval S Valve Clinical Trial for Extended CE Mark
Actual Study Start Date : February 23, 2010
Actual Primary Completion Date : October 31, 2014
Actual Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Artificial Limbs

Arm Intervention/treatment
Experimental: Perceval S Valve Prosthesis
Patients who underwent replacement of diseased or malfunctioning native aortic valve with the Perceval S Valve prosthesis
Device: Perceval S Valve Prosthesis
Replacement of diseased or malfunctioning native aortic valve with the Perceval S valve prosthesis




Primary Outcome Measures :
  1. Evaluation of the safety: incidence of mortality [ Time Frame: 12 months after OP ]
    Incidence of mortality

  2. Evaluation of the safety: Incidence of morbidity [ Time Frame: 12 months after OP ]

    Incidence of morbidity

    Mortality and morbidity, adverse event categories: valvular thrombosis, thromboembolism, hemorrhage, paravalvular leak, endocarditis, hemolysis, SVD, non structural dysfunction, reoperation, explant, death, device dislodgement and device migration


  3. Evaluation of NYHA functional class [ Time Frame: 12 months after OP ]
    Change of NYHA functional class

  4. Evaluation of haemodynamic performance: mean and peak gradients [ Time Frame: 12 months after OP ]
    Change of aortic mean gradient and peak gradient (mmHg)

  5. Evaluation of haemodynamic performance: Effective Orifice Area (EOA) and Effective Orifice Area indexed (EOAI) [ Time Frame: 12 months after OP ]
    Change of EOA (cm2) and EOAI (cm2/m2) PI, cardiac output, cardiac index and degree of regurgitation

  6. Evaluation of haemodynamic performance: Cardiac Index [ Time Frame: 12 months after OP ]
    Change of Cardiac Index (l/min/m2)

  7. Evaluation of haemodynamic performance: Cardiac Output [ Time Frame: 12 months after OP ]
    Change of Cardiac Output (l/min)

  8. Evaluation of haemodynamic performance: incidence and degree of regurgitation [ Time Frame: 12 months after OP ]
    Change of incidence (%) and degree of regurgitation (none, trace, mild, moderate, severe)


Secondary Outcome Measures :
  1. Evaluation of the safety: incidence of mortality [ Time Frame: 3-6 months ]
    Incidence of mortality

  2. Evaluation of the safety: Incidence of morbidity [ Time Frame: 3-6 months ]
    Incidence of morbidity

  3. Evaluation of NYHA functional class [ Time Frame: 3-6 months ]
    Change of NYHA functional class

  4. Evaluation of haemodynamic performance [ Time Frame: 3-6 months ]
    haemodynamic performance: mean gradient and peak gradient, EOA, EOAI, cardiac output, cardiac index and degree of regurgitation

  5. Evaluation of the safety: Incidence of mortality [ Time Frame: up to 10 years ]
    Incidence of mortality

  6. Evaluation of the safety: Incidence of morbidity [ Time Frame: up to 10 years ]
    Incidence of morbidity

  7. Evaluation of NYHA functional class [ Time Frame: up to 10 years ]
    Change of NYHA functional class

  8. Evaluation of haemodynamic performance [ Time Frame: up to 10 years ]
    haemodynamic performance: mean gradient and peak gradient, EOA, EOAI, cardiac output, cardiac index and degree of regurgitation



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects of age > 65 years;
  2. Subjects with aortic valve stenosis or steno-insufficiency;
  3. Subjects in which preoperative evaluation indicated the need for native or prosthetic aortic valve replacement with a biological prosthesis;
  4. Subjects willing to sign the informed consent;
  5. Subjects willing to undergo all medical follow-up, echocardiography examinations and laboratory tests planned for the Study

Exclusion Criteria:

  1. Subjects involved in any other clinical study for drugs or devices;
  2. Subjects with a previously implanted Perceval S prosthesis, within the clinical study, that requires replacement
  3. Subjects with previous implantation of valve prostheses or annuloplasty ring not being replaced by the study valve
  4. Subjects requiring simultaneous cardiac procedures, apart from septal myectomy and/or coronary by-pass
  5. Subjects who require double or multiple valve replacement or repair in whom the mitral, tricuspid, or pulmonic valve would be replaced with a non-Perceval S valve or repaired
  6. Subjects with aneurysmal dilation or dissection of the ascending aortic wall
  7. Subjects needing non elective intervention
  8. Subjects with active endocarditis
  9. Subjects with active myocarditis
  10. Subjects with congenital bicuspid aortic valve
  11. Subjects with aortic root enlargement, where the ratio between the diameter of the sino-tubular junction and the annulus diameter, assessed by TTE, is > 1.3 (see Attachment 1 for reference)
  12. Subjects with aortic root height (measured from aortic annulus to sino-tubular junction) ≥ 21 mm for size 21, ≥ 22.5 mm for size 23 and ≥ 24 mm for size 25, and ≥ 25 mm for size XL/27
  13. Subjects with myocardial infarction < 90 days before the planned valve implant surgery
  14. Subjects with known hypersensitivity to nickel alloys
  15. The subject has a documented history of substance (drug or alcohol) abuse
  16. The subject is a prison inmate, institutionalized, or is unable to give informed consent;
  17. The subject has a major or progressive non-cardiac disease that, in the investigator's experience, results in a life expectancy shorter than 1 year, or the implant of the device produces an unacceptable increased risk to the patient
  18. The subject is undergoing renal dialysis for chronic renal failure or has hyperparathyroidism
  19. The subject has had an acute preoperative neurological deficit, myocardial infarction, or cardiac event that has not returned to baseline or stabilized ≥ 30 days prior to the planned valve implant surgery

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): NCT01368666


Locations
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Sponsors and Collaborators
Corcym S.r.l
Investigators
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Principal Investigator: A. Haverich, Prof. Hannover Medical School
Publications of Results:
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Responsible Party: Corcym S.r.l
ClinicalTrials.gov Identifier: NCT01368666    
Other Study ID Numbers: TPS001
First Posted: June 8, 2011    Key Record Dates
Last Update Posted: July 8, 2022
Last Verified: August 2019
Keywords provided by Corcym S.r.l:
Aortic valve replacement
Aortic stenosis
Biological valve
Sutureless valve
Stented valve
Aortic Valve Disease