Trials Today

The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study

Purpose

The purpose of this study is to further evaluate the safety and effectiveness of the Harmony™ TPV system. The Pivotal/CAS phases of the study have transitioned into a post-approval study to confirm the long-term functionality of transcatheter implantation of the Medtronic Harmony TPV.

Conditions

Congenital Heart Disease
Tetrology of Fallot
RVOT Anomaly
Pulmonary Regurgitation

Eligibility

Eligible Ages: All ages
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Subject has severe pulmonary regurgitation as assessed via echocardiography or CMR determined PR fraction >/= 30% - Subject has clinical indication for surgical placement of an RV-PA conduit or bioprosthetic pulmonary valve - Subject is willing to consent to participate

Exclusion Criteria

Patients with right ventricular outflow tract obstruction (RVOTO) lesions surgically treated with an RV-to-PA conduit implant - RVOT anatomy or morphology that is unfavorable for device anchoring - Positive pregnancy test - Life expectancy of less than 1 year

Study Design

Phase: N/A
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Other Harmony TPV System	Intervention Device: Harmony Transcatheter Pulmonary Valves and Delivery Systems	Device: Harmony TPV System The Harmony™ TPV (Model NTPV0022) is comprised of a 22mm porcine pericardium valve, sewn to a polyester-covered nitinol frame. The Harmony TPV 25 and mTPV 25 (Model HTPV254952 and HTPV254252, respectively) is comprised of a 25mm porcine pericardium valve, sewn to a polyester covered asymmetrical hourglass nitinol frame with larger diameter inflow and outflow as well as shorter length compared to TPV 22 (Harmony TPV 25 Model HTPV254952 is not applicable for Continued Clinical Experience). The Harmony Delivery System (DS) for the TPV 22, TPV 25, and mTPV 25 (NTPVDS0022 and HTPVDS0025) are all 25 Fr delivery systems using a coil loading catheter.

Recruiting Locations

More Details

NCT ID: NCT02979587
Status: Active, not recruiting
Sponsor: Medtronic Heart Valves

Detailed Description

The continued clinical experience addendum is a prospective, multi-center, non-randomized, interventional study to evaluate the safety and effectiveness of the Harmony TPV system. All implanted subjects will receive the Harmony TPV 22 or Harmony mTPV 25 device. This phase allows up to 45 subjects implanted with TPV 22 in the United States and Canada, and up to 84 subjects implanted with mTPV 25 in the United States. The Post Approval Phase (PAS) addendum is a prospective, multi-center, non-randomized, post-market study to evaluate the safety and effectiveness of the Harmony TPV system in the United States. All implanted subjects have been implanted with the Harmony TPV 22 or Harmony mTPV 25 device during the pivotal or CAS phase of the study. The PAS addendum extends follow-up from five years to ten years for consenting subjects.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.