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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: February 6, 2017
Last verified: February 2017
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: Intervention Model: Single Group Assignment
Masking: None (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 or Reintervention [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • 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.

Enrollment: 81
Actual Study Start Date: April 2008
Estimated Study Completion Date: November 2019
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SAPIEN THV Device: SAPIEN Transcatheter Valve Implantation
Device Implantation

Detailed Description:
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.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00676689

United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Florida
Miami Children's Hospital
Miami, Florida, United States, 33155
United States, Georgia
Emory University Hospital/ Children's Healthcare of Atlanta (CHOA)
Atlanta, Georgia, United States, 30341
United States, Illinois
Rush Medical Center
Chicago, Illinois, United States, 60612
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48130
United States, New York
Children's Hospital of New York
New York, New York, United States, 10032
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Edwards Lifesciences
Principal Investigator: Ziyad M Hijazi, M.D. Rush University Medical Center
  More Information

Responsible Party: Edwards Lifesciences Identifier: NCT00676689     History of Changes
Other Study ID Numbers: 2006-09
Study First Received: May 9, 2008
Results First Received: May 4, 2016
Last Updated: February 6, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

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

Additional relevant MeSH terms:
Pulmonary Valve Stenosis
Pulmonary Valve Insufficiency
Respiratory Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Respiration Disorders
Respiratory Tract Diseases processed this record on September 21, 2017