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
  Purpose

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.


Condition Intervention
Pulmonary Valve Insufficiency
Pulmonary Regurgitation
Dysfunctional RVOT Conduit
Pulmonary Obstruction
Pulmonary Stenosis
Device: SAPIEN Transcatheter Valve Implantation

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Implantation of the SAPIEN Transcatheter Heart Valve (THV) in the Pulmonic Position

Resource links provided by NLM:


Further study details as provided by Edwards Lifesciences:

Primary Outcome Measures:
  • Freedom from device or procedure related death and/or reoperation at 1 year. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 70
Study Start Date: April 2008
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Device: SAPIEN Transcatheter Valve Implantation
Device Implantation

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676689

Contacts
Contact: Richard Ney 336-480-4468 richard_ney@edwards.com

Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Evan Zahn, M.D    310-423-1153    Evan.Zahn@cshs.org   
Principal Investigator: Evan Zahn, MD         
United States, Florida
Miami Children's Hospital Recruiting
Miami, Florida, United States, 33155
Contact: Darren Berman, MD    305-662-8301    darren.berman@mch.com   
Principal Investigator: Darren Berman, MD         
United States, Georgia
Emory University Hospital/ Children's Healthcare of Atlanta (CHOA) Recruiting
Atlanta, Georgia, United States, 30341
Contact: Dennis Kim, MD    404-256-2593    kimd@kidsheart.com   
Principal Investigator: Dennis Kim, MD         
United States, Illinois
Rush Medical Center Active, not recruiting
Chicago, Illinois, United States, 60612
United States, Massachusetts
Children's Hospital Boston Withdrawn
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48130
Contact: Aimee K Armstrong, MD    734-936-8993    kimd@kidsheart.com   
Principal Investigator: Aimee K Armstrong, MD         
United States, New York
Children's Hospital of New York Recruiting
New York, New York, United States, 10032
Contact: Julie Vincent, MD    212-305-6069    jav2136@mail.cumc.columbia.edu   
Principal Investigator: Julie Vincent, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Gregory Fleming, MD    919-681-2880    Gregory.fleming@dm.duke.edu   
Contact: Mingfen Xu    919-668-6352    mingfen.xu@Duke.edu   
Principal Investigator: Gregory Fleming, MD         
Sponsors and Collaborators
Edwards Lifesciences
Investigators
Principal Investigator: Ziyad M Hijazi, M.D. Rush University Medical Center
  More Information

No publications provided

Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT00676689     History of Changes
Other Study ID Numbers: 2006-09
Study First Received: May 9, 2008
Last Updated: October 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Edwards Lifesciences:
Pulmonic
Regurgitation
Pulmonary Valve Conduit
Stenosis
Congenital Heart Defect

Additional relevant MeSH terms:
Constriction, Pathologic
Pulmonary Valve Insufficiency
Pulmonary Valve Stenosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on April 15, 2014