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Summary

for people ages 7–75 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

The Covered Cheatham-Platinum Stent (CCPS) is being study for repair of tears that occur in the pulmonary artery during dilation (enlargement) of a conduit (passageway) connecting the right ventricle of the heart to the pulmonary arteries. Patients undergoing replacement of their pulmonary valve by transcatheter technique Melody Valve) are at risk of developing such tears in the process of preparing the conduit to accept the new valve. In order to implant such a valve, the connection between the right ventricle and the pulmonary arteries often needs to be enlarged. High pressure balloons may be needed and these balloons can sometimes cause tears in or even rupture of the connecting conduit. Such tears can allow blood to flow into the chest and rarely this can lead to a life-threatening emergency. Experience suggests that such tears can be closed by implanting into the conduit a metallic stent with an outer covering, rebuilding the wall and allowing continuation of the valve implant.

Details

Recent clinical reports from multiple pediatric cardiology programs around the world indicate that the conduit can be repaired using such a stent. In the United States there are no commercially available, FDA approved, covered stents of the size required. The Covered Cheatham Platinum Stent (CCPS) manufactured by the NuMED Corporation of Hopkinton, New York has been used in Europe since 2003 and more recently in Canada. The CCPS device is not yet approved by the Food & Drug Administration (FDA). However, it has been used at many hospitals in the U.S. to repair Right Ventricle to pulmonary artery conduits under Emergency and Compassionate Use circumstances. The NuMED Covered Cheatham-Platinum Stent (CCPS) is currently being studied for use in other areas of the body. The investigators are now studying its use in RV-PA conduits. The use of the Covered Cheatham Platinum Stent in this research study is investigational.

Only patients found to have a conduit tear during a Melody Valve implant procedure will be eligible for inclusion into the trial. Implant technique is left to the catheterization physician. Clinical data obtained during the catheterization, before and after the CCPS implant will be studied in order to understand factors leading up to the tear and to evaluate how successful the CCPS is in repairing such defects. Melody valve implant patients are routinely seen for clinical and echocardiographic reevaluation 6 months after implant. Patients who have received a CCPS during their Melody valve procedure will likewise be seen. Results from their clinical evaluation will be reviewed to make sure that the presence of a CCPS does not diminish the effectiveness of the Melody valve. Finally, the catheterization angiograms and 6 month follow up echocardiograms will be reviewed by an independent expert to confirm the clinical readings.

Keywords

Pulmonary Stenosis Pulmonary Regurgitation Tetralogy of Fallot Pulmonary Valve Stenosis Pulmonary Valve Insufficiency Respiratory Insufficiency

Eligibility

You can join if…

Open to people ages 7–75

Precatheterization Inclusion Criteria:

  1. Patient meets institutional criterion for placement of Melody® TPV
  2. Patient size adequate to receive Melody TPV® implantation via venous access using the Ensemble® Transcatheter Delivery System
  3. RV-PA conduit original size > 16 mm diameter
  4. Patient age between 10 and 75 years

Catheterization Inclusion Criteria:

  1. Angiographic evidence for RV-PA conduit disruption including: dissection, aneurysm,pseudo-aneurysm, tears or rupture
  2. Recognition and treatment of conduit disruption may occur before, during or after implantation of the Melody® TPV
  3. Conduit disruption related to prior intervention, identified angiographically before conduit dilation is performed during the Melody® implant procedure, can be eligible for CCPS implantation and study inclusion

You CAN'T join if...

Precatheterization Exclusion Criteria:

  1. Patient size too small for transvenous placement of the Melody® TPV
  2. Bloodstream infection, including endocarditis
  3. Pregnancy
  4. Prisoners and adults lacking the capacity to give consent

Catheterization Exclusion Criteria:

  1. Conduit size is not suitable (too small or too large) for a Melody® TPV
  2. Risk of coronary compression has been identified
  3. Lack of angiographic evidence for RV-PA conduit disruption - Prophylactic use of study CCPS is prohibited
  4. Vessel injury occurring in either the right or left branch pulmonary arteries -If injury to branch pulmonary arteries occurs during the catheterization and covered stent usage is indicated, Emergency Use guidelines must be employed

Locations

  • University of California, San Francisco
    San Francisco, California, 94143, United States
  • Children's Hospital of Los Angeles
    Los Angeles, California, 90027, United States
  • University of California, Los Angeles Medical Center
    Los Angeles, California, 90291, United States
  • Loma Linda University Health
    Loma Linda, California, 92354, United States
  • Sunrise Children's, Children's Heart Center
    Las Vegas, Nevada, 89109, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Richard E. Ringel
ID
NCT01824160
Study Type
Interventional
Last Updated
February 2016