Melody PB1016 Surveillance Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2018-08-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Melody Transcatheter Pulmonary Valve Study: Post Approval Study of the Investigational Device Exemption Cohort

NCT00740870

Congenital Heart Defects Dysfunctional Right Ventricular Outflow Tract Conduits

COMPLETED NA

Melody® Transcatheter Pulmonary Valve Post-Approval Study

NCT01186692

Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduit

COMPLETED NA

Non Interventional Study on Pulmonary Valve Replacement by Thranscatheter Pulmonary Valve Melody™

NCT02023775

Right Ventricular Congenital Cardiopathies

COMPLETED

Infective Endocarditis in Percutaneous Pulmonary Revalvulation: Comparison Between Melody and Sapien Valves

NCT06186258

Infective Endocarditis Congenital Heart Disease Percutaneous Pulmonary Valve Implantation

COMPLETED

The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study

NCT02979587

Congenital Heart Disease Tetrology of Fallot RVOT Anomaly +1 more

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dysfunctional RVOT Conduits in Patients With Congenital Heart Defects

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Melody TPV PB1016

Group Type OTHER

Melody Transcatheter Pulmonary Valve PB1016

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Melody Transcatheter Pulmonary Valve PB1016

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No