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

Pulmonary Regurgitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00676689
• Other study ID #: 2006-09
• Status: Completed
• Phase: N/A
• Start date: April 8, 2008
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2020
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: December 31, 2019
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Dysfunctional RVOT Conduit
• Pulmonary Obstruction
• Pulmonary Regurgitation
• Pulmonary Stenosis
• Pulmonary Valve Insufficiency
• Pulmonary Valve Stenosis
• Respiratory Insufficiency

Intervention

Device:
• SAPIEN Transcatheter Valve Implantation
Device Implantation

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University Hospital/ Children's Healthcare of Atlanta (CHOA)	Atlanta	Georgia
United States	Rush Medical Center	Chicago	Illinois
United States	Duke University Medical Center	Durham	North Carolina
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Miami Children's Hospital	Miami	Florida
United States	Children's Hospital of New York	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom From Device or Procedure Related Death or Reintervention		1 year
Secondary	Freedom From MACCE	Clinical Events Committee (CEC) adjudicated.	6 Months
Secondary	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