The Medtronic Melody(R) Transcatheter Pulmonary Valve Post-approval Study

Study ID
STU 072011-085

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Jessica Crockett
214.456.4213
jessica.crockett@childrens.com

Principal Investigator
Thomas Zellers

Summary

This is a prospective, non-randomized, historically-controlled, multi-center study, with each center following a common Clinical Investigation Plan (CIP). A total of 100 subjects will be implanted among ten study centers: each center will implant a target number of 10 subjects, and no center will implant more than 15 subjects for the study.

Each implanted subject will be followed for five years or until the TPV is explanted.

Enrollment of all 100 subjects is estimated to be completed by March 2012, with follow-up estimated to be completed by March 2017.

The primary outcome measures for this study are: acceptable TPV hemodynamic function at six months after successful TPV implantation which is determined as a composite of the following:

* Mean RVOT gradient is less than or equal to 30 mmHg as measure by CW Doppler, and

* Severity of pulmonary regurgitation is less than moderate by Doppler echocardiography, and

* Free from RVOT conduit reoperation or catheter re-intervention at six months after TPV implantation.

Secondary outcome measures for this study are:

* % of patients with procedural success

* % of subjects with serious procedural adverse events

* % of subjects with serious device-related adverse events at six months post-implant

* Incidence of serious device-related adverse events over the follow-up period

* Freedom from stent fracture

* Freedom from re-intervention on the TPV

* Freedom from RVOT conduit reoperation

* Freedom from death (all-cause, procedural, and device-related)

* Changes in NYHA functional classification

Participant Eligibility

All male and female patients with complex congenital heart defects that have been palliated with RVOT conduits which have become dysfunctional and have the following clinical indicators:

* Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 mm in diameter when originally implanted and

* Regurgitation that is moderate or greater

* Stenosis with a mean RVOT gradient ≥ 35 mmHg