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

• ClinicalTrials.gov Identifier: NCT00676689
• Recruitment Status: Completed
• First Posted: May 13, 2008
• Results First Posted: September 1, 2016
• Last Update Posted: February 26, 2020
• Sponsor: Edwards Lifesciences
• Information provided by (Responsible Party): Edwards Lifesciences

Study Description

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 81 participants
• Allocation: N/A
• 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
• Actual Study Completion Date: December 31, 2019

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• 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).

Contacts and Locations

Locations

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

Investigators

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

More Information

• Responsible Party: Edwards Lifesciences
• ClinicalTrials.gov Identifier: NCT00676689
• Other Study ID Numbers: 2006-09
• First Posted: May 13, 2008
• Results First Posted: September 1, 2016
• Last Update Posted: February 26, 2020
• Last Verified: February 2020

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

Keywords provided by Edwards Lifesciences:

Pulmonic; Regurgitation; Pulmonary Valve Conduit; Stenosis; Congenital Heart Defect

Additional relevant MeSH terms:

Respiratory Insufficiency; Lung Diseases, Obstructive; Pulmonary Valve Insufficiency; Pulmonary Valve Stenosis; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases; Ventricular Outflow Obstruction; Lung Diseases