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

This study is currently recruiting participants.
Verified October 2013 by Edwards Lifesciences
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT00676689
First received: May 9, 2008
Last updated: October 4, 2013
Last verified: October 2013

May 9, 2008
October 4, 2013
April 2008
January 2014   (final data collection date for primary outcome measure)
Freedom from device or procedure related death and/or reoperation at 1 year. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Freedom from death and reoperation at 6 months. [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00676689 on ClinicalTrials.gov Archive Site
  • Freedom from MACCE at 6 months [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
  • Functional Improvement [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Freedom from MACCE at 6 months [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
  • Functional Improvement [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
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 feasibility 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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
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: 1
Intervention: Device: SAPIEN Transcatheter Valve Implantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
March 2018
January 2014   (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.
Both
Not Provided
No
Contact: Richard Ney 336-480-4468 richard_ney@edwards.com
United States
 
NCT00676689
2006-09
Yes
Edwards Lifesciences
Edwards Lifesciences
Not Provided
Principal Investigator: Ziyad M Hijazi, M.D. Rush University Medical Center
Edwards Lifesciences
October 2013

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