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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Valve Insufficiency; Pulmonary Regurgitation; Pulmonary Stenosis; Dysfunctional RVOT Conduit; Pulmonary Obstruction
• Intervention / Treatment: Device: SAPIEN Transcatheter Valve 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.

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
  • Florida
    • Miami, Florida, United States, 33155
      • Miami Children's Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30341
      • Emory University Hospital/ Children's Healthcare of Atlanta (CHOA)
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48130
      • University of Michigan
  • New York
    • New York, New York, United States, 10032
      • Children's Hospital of New York
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SAPIEN THV	Device: SAPIEN Transcatheter Valve Implantation; Device Implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Freedom From Device or Procedure Related Death or Reintervention	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom From MACCE	Clinical Events Committee (CEC) adjudicated.	6 Months
Functional Improvement	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.	6 months

Collaborators and Investigators

• Sponsor: Edwards Lifesciences
• Investigators: Principal Investigator: Ziyad M Hijazi, M.D., Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 8, 2008
• Primary Completion (ACTUAL): November 1, 2015
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: May 9, 2008
• First Submitted That Met QC Criteria: May 12, 2008
• First Posted (ESTIMATE): May 13, 2008

Study Record Updates

• Last Update Posted (ACTUAL): February 26, 2020
• Last Update Submitted That Met QC Criteria: February 18, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Stenosis; Regurgitation; Pulmonic; Congenital Heart Defect; Pulmonary Valve Conduit
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Heart Valve Diseases; Ventricular Outflow Obstruction; Respiratory Insufficiency; Airway Obstruction; Pulmonary Valve Insufficiency; Pulmonary Valve Stenosis
• Other Study ID Numbers: 2006-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes