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Clinical Trials/jRCT2002230001
jRCT2002230001Active, not recruitingNot Applicable

Harmony Transcatheter Pulmonary Valve Use-Results Surveillance

Medtronic Japan0 sites42 target enrollmentStarted: March 2, 2023Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
42
Primary Endpoint
Proportion of patients with favorable hemodynamic function without valve reintervention
Study OverviewEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
No limit to No limit (—)
Sex
All

Inclusion Criteria

  • •The Product is for use in patients with severe pulmonary regurgitation who have previously undergone surgical repair or transcatheter intervention (balloon valvuloplasty) to the right ventricular outflow tract, and are in clinical need of a pulmonary valve replacement. However, it is intended for use in patients for whom surgical procedures pose a high risk, and for whom the Product is deemed to be the optimal treatment. Note that this product should not be used for patients who have an artificial valve or a right ventricle to pulmonary artery conduit implanted.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Proportion of patients with favorable hemodynamic function without valve reintervention

Time Frame: 1 year after the initial procedure

Proportion of patients with favorable hemodynamic function without valve reintervention at 1 year after the initial procedure

Procedure success rate

Time Frame: 30 days after the initial procedure

Procedure success rate at 30 days after the initial procedure

Device success rate

Time Frame: up to 5 years after the initial procedure

Device success rate up to 5 years after the initial procedure

RVOT re-operation rate attributable to the Product

Time Frame: up to 5 years after the initial procedure

RVOT re-operation rate attributable to the Product up to 5 years after the initial procedure

Re-interventation rate for the product

Time Frame: up to 5 years after the initial procedure

Re-interventation rate for the product up to 5 years after the initial procedure

Incidence of valve dysfunction

Time Frame: up to 5 years after the initial procedure

Incidence of valve dysfunction up to 5 years after the initial procedure

Death due to any cause

Time Frame: up to 5 years after the initial procedure

Death due to any cause up to 5 years after the initial procedure

Adverse events and defects for which a causal relationship with the procedure or the Product cannot be ruled out

Time Frame: up to 5 years after the initial procedure

Adverse events and defects for which a causal relationship with the procedure or the Product cannot be ruled out (up to 5 years after the initial procedure)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Medtronic Japan

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