N/A
N=171
Melody Transcatheter Pulmonary Valve Study: Post Approval Study of the Investigational Device Exemption Cohort
Congenital Heart Defects · Dysfunctional Right Ventricular Outflow Tract Conduits
Bottom Line
View on ClinicalTrials.gov: NCT00740870 ↗Enrolled (actual)
171
Serious AEs
63.5%
Results posted
Jul 2017
Primary outcome: Primary: Kaplan-Meier Freedom From TPV Dysfunction — 72.9 percentage of subjects — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcatheter Pulmonary Valve replacement (Device)
- Age
- Pediatric, Adult, Older Adult · 5+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiovascular
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Kaplan-Meier Freedom From TPV Dysfunction |
72.9 | <0.0001 sig |
| SECONDARY Freedom From TPV Dysfunction at 10 Years |
52.9 | — |
| SECONDARY Procedural Success |
94.7 | — |
| SECONDARY Serious Procedural Adverse Event (AE) |
13.2 | — |
| SECONDARY Serious Procedural Adverse Event (AE) |
13.2 | — |
| SECONDARY Serious Device-related Adverse Event |
41.3 | — |
| SECONDARY Serious Device-related Adverse Event |
41.3 | — |
| SECONDARY Kaplan-Meier Freedom From Major Stent Fracture at 5 Years |
84.3 | — |
| SECONDARY Kaplan-Meier Freedom From Major Stent Fracture at 10 Years |
83.7 | — |
| SECONDARY Kaplan-Meier Freedom From Catheter Re-intervention on TPV |
73.1 | — |
| SECONDARY Kaplan-Meier Freedom From Catheter Re-intervention on TPV |
73.1 | — |
| SECONDARY Kaplan-Meier Freedom From Surgical Replacement of the RVOT Conduit |
78.9 | — |
| SECONDARY Kaplan-Meier Freedom From Surgical Replacement of the RVOT Conduit |
78.9 | — |
| SECONDARY Kaplan-Meier Freedom From Death (All-cause, Procedural and Device-related) |
90.2 | — |
| SECONDARY Kaplan-Meier Freedom From Death (All-cause, Procedural and Device-related) |
90.2 | — |
| SECONDARY Functional Assessment (NYHA Classification) |
102; 39; 1; 1 | — |
Summary
The primary objective is to confirm the long-term functionality of implantation of the Medtronic Melody TPV at 5 years is no worse than the historical control established through literature review. The secondary objectives are to evaluate long-term functionality at 10 years and to assess safety, procedural success, and clinical utility of transcatheter implantation of the Melody TPV.
Eligibility Criteria
Inclusion Criteria
- Age greater than or equal to 5 years of age
- Weight greater than or equal to 30 kilograms
- Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 mm in diameter when originally implanted, or a stented bioprosthesis with a rigid circumferential sewing ring in the RVOT that has an internal diameter greater than or equal to 18 mm and less than or equal to 22 mm when originally implanted.
- Any of the following by transthoracic echocardiography:
- For patients in New York Heart Association (NYHA) Classification II, III, or IV: Moderate (3+) or severe (4+) pulmonary regurgitation AND/OR Mean RVOT gradient greater than or equal to 35 mmHg
- For patients in NYHA Classification I: Severe (4+) pulmonary regurgitation with RV dilatation or dysfunction AND/OR Mean RVOT gradient greater or equal to 40 mmHg
Exclusion Criteria
- Active endocarditis
- Major or progressive non-cardiac disease (liver failure, renal failure, cancer)that has a life expectancy of less than one year
- Patient or guardian unwilling or unable to provide written informed consent or comply with follow-up requirements
- Obstruction of the central veins (including the superior and inferior vena cava, bilateral iliac veins) such that the delivery system cannot be advanced to the heart via transvenous approach from either femoral vein or internal jugular vein
- Positive urine or serum pregnancy test 24 hours prior to procedure in female patients of child bearing potential
- Known intravenous drug abuse
Data sourced from ClinicalTrials.gov (NCT00740870). 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.