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

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. Identifier: NCT00676689
Recruitment Status : Active, not recruiting
First Posted : May 13, 2008
Results First Posted : September 1, 2016
Last Update Posted : October 5, 2017
Information provided by (Responsible Party):
Edwards Lifesciences

Brief Summary:
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 or disease Intervention/treatment Phase
Pulmonary Valve Insufficiency Pulmonary Regurgitation Dysfunctional RVOT Conduit Pulmonary Obstruction Pulmonary Stenosis Device: SAPIEN Transcatheter Valve Implantation Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
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
Actual Study Start Date : April 8, 2008
Actual Primary Completion Date : November 2015
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: SAPIEN THV Device: SAPIEN Transcatheter Valve Implantation
Device Implantation

Primary Outcome Measures :
  1. Freedom From Device or Procedure Related Death or Reintervention [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Freedom From MACCE [ Time Frame: 6 Months ]
    Clinical Events Committee (CEC) adjudicated.

  2. 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.

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Ages Eligible for Study:   Child, Adult, Older Adult
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).

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 identifier (NCT number): 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

Responsible Party: Edwards Lifesciences Identifier: NCT00676689     History of Changes
Other Study ID Numbers: 2006-09
First Posted: May 13, 2008    Key Record Dates
Results First Posted: September 1, 2016
Last Update Posted: October 5, 2017
Last Verified: September 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