COMPASSION: COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal THV

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Edwards Lifesciences Identifier:
First received: May 9, 2008
Last updated: July 21, 2016
Last verified: July 2016

May 9, 2008
July 21, 2016
April 2008
November 2015   (Final data collection date for primary outcome measure)
Freedom From Device or Procedure Related Death or Reintervention [ Time Frame: 1 year ]
Freedom from death and reoperation at 6 months. [ Time Frame: 6 Months ]
Complete list of historical versions of study NCT00676689 on Archive Site
  • Freedom From MACCE [ Time Frame: 6 Months ]
    Clinical Events Committee (CEC) adjudicated.
  • Functional Improvement [ Time Frame: 6 months ]

    Functional improvement at 6 months as defined by:

    a) Improved valve hemodynamics as demonstrated via Transthoracic Echo: i) Decrease in pulmonary regurgitation to mild or less for regurgitant lesions ii) Decrease in mean pulmonary gradient to less than 30 mmHg for stenotic lesions iii) Improvement in both i) and ii) above for mixed lesions b) Improvement of ≥ 1 NYHA functional class from baseline for patients with NYHA functional class ≥ 2 at baseline c) Freedom from recurrent pulmonary stenosis.

  • Freedom from MACCE at 6 months [ Time Frame: 6 Months ]
  • Functional Improvement [ Time Frame: 6 months ]
Not Provided
Not Provided
COMPASSION: COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal THV
Implantation of the SAPIEN Transcatheter Heart Valve (THV) in the Pulmonic Position
To assess the safety and effectiveness of pulmonic THV implantation in subjects with dysfunctional RVOT conduit requiring treatment for moderate or severe pulmonary regurgitation (≥3+ pulmonary regurgitation) and/or RVOT conduit obstruction (mean gradient of >=35mmHg) by TTE.
The study design is a multi-center, prospective, non-randomized study of up to 70 implanted subjects (US) with no site representing more than 30% of the implanted subjects. The subjects will include those subjects who have previously undergone placement of a conduit between the right ventricle and pulmonary artery and now present with a dysfunctional RVOT conduit requiring treatment for moderate or severe pulmonary regurgitation and/or RVOT conduit obstruction.
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pulmonary Valve Insufficiency
  • Pulmonary Regurgitation
  • Dysfunctional RVOT Conduit
  • Pulmonary Obstruction
  • Pulmonary Stenosis
Device: SAPIEN Transcatheter Valve Implantation
Device Implantation
Experimental: SAPIEN THV
Intervention: Device: SAPIEN Transcatheter Valve Implantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
November 2019
November 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria

  1. Weight must be equal to or exceed 35 kilograms.
  2. In situ conduit size of ≥ 16 mm and ≤ 24 mm in diameter.
  3. Subject presents with moderate or severe pulmonary regurgitation defined as ≥3+ pulmonary regurgitation by TTE or RVOT conduit obstruction with a mean gradient of >= 35 mmHg by TTE.
  4. Subject is symptomatic as evidenced by cardiopulmonary exercise testing.
  5. The subject or the subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
  6. The subject and the treating physician agree that the subject will return for all required post-procedure follow up visits and the subject will comply with protocol-required follow-up visits.
  7. Catheterization is determined to be feasible by the treating physician.

Exclusion Criteria

  1. Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 4 weeks after discontinuation of antibiotics)
  2. Previously enrolled in this study.
  3. Subject with pre-existing prosthetic heart valves in any position*.
  4. Severe chest wall deformity.
  5. Leukopenia (WBC<3000 mm3).
  6. Acute or chronic anemia (Hb <9 g/dL).
  7. Platelet count <100,000 cells/mm3.
  8. In the judgment of the Investigator, percutaneous introduction and delivery of the SAPIEN THV device is not feasible.
  9. Need for emergency cardiac or vascular surgery, including pulmonary embolectomy, for any reason.
  10. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
  11. History of, or active endocarditis.*
  12. History of, or current intravenous drug abuse.
  13. A known hypersensitivity to aspirin or heparin.
  14. Currently participating in an investigational drug or another device study. [Note: Trials requiring extended follow up for products that were investigational, but have since become commercially available, are not considered investigational devices.]
  15. Major or progressive noncardiac disease resulting in a life expectancy of <1yr.
  16. Obstruction of the central veins preventing advancement of the pulmonic bioprosthesis delivery system to the heart.
  17. Positive urine or serum pregnancy test in female subjects of child-bearing potential.
  18. Right ventricular outflow tract aneurysm.
  19. Ileofemoral vessel characteristics that would preclude safe placement of 22F or 24F introducer sheath.
  20. Need for concomitant interventional procedures such as ASD or VSD closure.
  21. Previous angiographic evidence of coronary artery compression.
Sexes Eligible for Study: All
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Not Provided
Edwards Lifesciences
Edwards Lifesciences
Not Provided
Principal Investigator: Ziyad M Hijazi, M.D. Rush University Medical Center
Edwards Lifesciences
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP