Pulmonary Artery Repair With Covered Stents
Condition: Pulmonary Stenosis; Pulmonary Regurgitation; Tetralogy of Fallot
MeSH terms: Tetralogy of Fallot; Pulmonary Valve Stenosis; Pulmonary Valve Insufficiency
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): Repair of RV-PA Conduit Disruption
Intervention type(s): Device
Intervention description(s): Repair of RV-PA Conduit Disruption
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment