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

Brief Title

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

Official Title

Implantation of the SAPIEN Transcatheter Heart Valve (THV) in the Pulmonic Position

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.
    

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


Primary Outcome

Freedom From Device or Procedure Related Death or Reintervention

Secondary Outcome

 Freedom From MACCE

Condition

Pulmonary Valve Insufficiency

Intervention

SAPIEN Transcatheter Valve Implantation

Study Arms / Comparison Groups

 SAPIEN THV
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

81

Start Date

April 8, 2008

Completion Date

December 31, 2019

Primary Completion Date

November 2015

Eligibility 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).
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Ziyad M Hijazi, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00676689

Organization ID

2006-09


Responsible Party

Sponsor

Study Sponsor

Edwards Lifesciences


Study Sponsor

Ziyad M Hijazi, M.D., Principal Investigator, Rush University Medical Center


Verification Date

February 2020