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

NCT00676689 | Completed Results DMC FDA Device

• 1 other identifier: 2006-09
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 7

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.

Conditions

Pulmonary Valve Insufficiency; Pulmonary Regurgitation; Dysfunctional RVOT Conduit; Pulmonary Obstruction; Pulmonary Stenosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Freedom From Device or Procedure Related Death or Reintervention

  1 year

Secondary Outcomes (2)

• Freedom From MACCE

  6 Months

• Functional Improvement

  6 months

Study Arms (1)

SAPIEN THV

EXPERIMENTAL

Device: SAPIEN Transcatheter Valve Implantation

Interventions

SAPIEN Transcatheter Valve Implantation DEVICE

Device Implantation

SAPIEN THV

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Weight must be equal to or exceed 35 kilograms.
• In situ conduit size of ≥ 16 mm and ≤ 24 mm in diameter.
• 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.
• Subject is symptomatic as evidenced by cardiopulmonary exercise testing.
• 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.
• 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.
• Catheterization is determined to be feasible by the treating physician.

You may not qualify if:

• Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 4 weeks after discontinuation of antibiotics)
• Previously enrolled in this study.
• Subject with pre-existing prosthetic heart valves in any position\*.
• Severe chest wall deformity.
• Leukopenia (WBC\<3000 mm3).
• Acute or chronic anemia (Hb \<9 g/dL).

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (7)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Miami Children's Hospital

Miami, Florida, 33155, United States

Location

Emory University Hospital/ Children's Healthcare of Atlanta (CHOA)

Atlanta, Georgia, 30341, United States

Location

Rush Medical Center

Chicago, Illinois, 60612, United States

Location

University of Michigan

Ann Arbor, Michigan, 48130, United States

Location

Children's Hospital of New York

New York, New York, 10032, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Pulmonary Valve Insufficiency; Airway Obstruction; Pulmonary Valve Stenosis; Gastroesophageal Reflux; Constriction, Pathologic; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Ventricular Outflow Obstruction; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Sharanjeet Dhanjal
• Organization: Edwards Lifesciences

sharanjeet_dhanjal@edwards.com

949-250-2083

Study Officials

• Ziyad M Hijazi, M.D.

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2008
• First Posted: May 13, 2008
• Study Start: April 8, 2008
• Primary Completion: November 1, 2015
• Study Completion: December 31, 2019
• Last Updated: February 26, 2020
• Results First Posted: September 1, 2016

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)