N/A N=39 Treatment

Melody PB1016 Surveillance Study

Dysfunctional RVOT Conduits in Patients With Congenital Heart Defects

Bottom Line

View on ClinicalTrials.gov: NCT02347189 ↗

Enrolled (actual)

Serious AEs

35.9%

Results posted

Nov 2017

Primary outcome: Primary: Number of Subjects With Acceptable TPV Hemodynamic Function At 6 Months — 25 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Melody Transcatheter Pulmonary Valve PB1016 (Device)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Medtronic Heart Valves
Primary completion: Nov 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects With Acceptable TPV Hemodynamic Function At 6 Months	25	—
SECONDARY Number of Subjects With Acceptable TPV Hemodynamic Function At 1 Year	23	—
SECONDARY Number of Subjects With Acceptable TPV Hemodynamic Function at 2 Years	25	—
SECONDARY Number of Subjects With Serious Procedure-related and Device-related Adverse Events	8; 8; 1; 3	—
SECONDARY Number of Subjects With Procedural Success	25	—
SECONDARY Percentage of Participants Who Met Various Safety Parameters of the Melody TPV PB1016	96.4; 96.7; 100; 96.7	—

Summary

Non-randomized, multi-center, prospective surveillance study to investigate and assess the residual risks, and to confirm the currently established safety and performance of the Melody TPV PB1016.

Eligibility Criteria

Inclusion Criteria

Patient eligible to receive Melody TPV PB1016 per current Instructions for Use (IFU) indications at time of study enrollment
Patient (or patient's legally authorized representative) is willing to consent to participate in the study and will commit to completion of all follow-up requirements.

Exclusion Criteria

Implantation in the aortic, tricuspid, or mitral position
Venous anatomy unable to accommodate a 22-Fr size introducer sheath
Obstruction of the central veins
Clinical or biological signs of infection including active endocarditis
History of intravenous substance abuse
Currently participating in an investigational drug or device study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02347189). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.