Medico-economic Evaluation of a Non-chirurgical Pulmonary Valve Replacement (REVALV)
REVALV
1 other identifier
interventional
93
1 country
1
Brief Summary
This prospective interventional study is designed to evaluate the cost/advantage ratio in the treatment of lesions of the right ventricular outflow tract using transcatheter pulmonary valved stent (Melody).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 27, 2010
CompletedFirst Posted
Study publicly available on registry
November 30, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedOctober 18, 2017
October 1, 2017
4.4 years
November 27, 2010
October 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cost induced by the transcatheter pulmonary valve insertion as compared to conventional surgical and insertion of a bare metal stent 24 months after insertion.
24 months after intervention
Secondary Outcomes (3)
Quality of life
24 months after intervention
procedure success rate
24 months after intervention
Does the patient need to be operated again?
24 months after intervention
Study Arms (3)
Melody
EXPERIMENTALinsertion of a pulmonic valved stent
Bare stent
ACTIVE COMPARATORinsertion of a bare metal stent
Surgery
ACTIVE COMPARATORconventional surgery methode.
Interventions
insertion of a pulmonic valved stent
insertion of a bare metal stent
Eligibility Criteria
You may qualify if:
- for the study:
- Lesions of the right ventricular outflow tract in need of surgery for stenosis or regurgitation
- for the Melody arm:
- A 5 to 70 years old patient
- Weight \>= 30kg
- RVOT \<= to 22mm
- Patient with a dysfunction circumferential prosthetic conduct of diameter \>= to 16mm.
You may not qualify if:
- Vein anatomy incompatibility with a 22Fr delivery health
- Left heart implantation
- RVOT incompatible with a anchoring of the stent (lik in patient operated of a tetralogy of fallot)
- Coronary anomaly with a coronary artery naer the RVOT
- Sever obstruction of the RVOT incompatible with balloon expansion
- Central vein obstruction
- Ongoing infection
- Active endocarditis
- Allergy for heparin or aspirin
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Necker Enfants Malades
Paris, 75015, France
Related Publications (1)
Fraisse A, Aldebert P, Malekzadeh-Milani S, Thambo JB, Piechaud JF, Aucoururier P, Chatelier G, Bonnet D, Iserin L, Bonello B, Assaidi A, Kammache I, Boudjemline Y. Melody (R) transcatheter pulmonary valve implantation: results from a French registry. Arch Cardiovasc Dis. 2014 Nov;107(11):607-14. doi: 10.1016/j.acvd.2014.10.001. Epub 2014 Nov 6.
PMID: 25453718DERIVED
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Boudjemline Younes, MD, PhD
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2010
First Posted
November 30, 2010
Study Start
March 1, 2009
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
October 18, 2017
Record last verified: 2017-10