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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00676689
First Posted: May 13, 2008
Last Update Posted: October 5, 2017
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.
Information provided by (Responsible Party):
Edwards Lifesciences
May 9, 2008
May 13, 2008
May 4, 2016
September 1, 2016
October 5, 2017
April 8, 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 ClinicalTrials.gov 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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
81
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).
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00676689
2006-09
Yes
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
Plan to Share IPD: No
Edwards Lifesciences
Edwards Lifesciences
Not Provided
Principal Investigator: Ziyad M Hijazi, M.D. Rush University Medical Center
Edwards Lifesciences
September 2017

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