Overview

This trial is active, not recruiting.

Conditions pulmonary stenosis, pulmonary regurgitation, tetralogy of fallot
Treatment repair of rv-pa conduit disruption
Sponsor Richard E. Ringel
Collaborator Medtronic
Start date December 2012
End date September 2014
Trial size 50 participants
Trial identifier NCT01824160, G120188

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Covered stenting of RV-PA conduit injury
repair of rv-pa conduit disruption
Repair of RV-PA Conduit Disruption

Primary Outcomes

Measure
Successful Repair of Conduit Disruption
time frame: Implant of Covered Sten, 6 month follow up

Eligibility Criteria

Male or female participants from 7 years up to 75 years old.

Inclusion Criteria: 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: a. Angiographic evidence for RV-PA conduit disruption including: dissection, aneurysm, pseudo-aneurysm, tears or rupture - Recognition and treatment of conduit disruption may occur before, during or after implantation of the Melody® TPV - 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 Exclusion Criteria: 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

Additional Information

Official title Pulmonary Artery Repair With Covered Stents
Principal investigator Richard Ringel, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Johns Hopkins University.