ClinicalTrials.gov

History of Changes for Study: NCT01250327
Medico-economic Evaluation of a Non-chirurgical Pulmonary Valve Replacement (REVALV) (REVALV)
Latest version (submitted October 16, 2017) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 November 29, 2010 None (earliest Version on record)
2 September 17, 2013 Recruitment Status, Study Status, Contacts/Locations, Sponsor/Collaborators and Study Design
3 October 16, 2017 Study Status and Conditions
Comparison Format:

Scroll up to access the controls

Study NCT01250327
Submitted Date:  November 29, 2010 (v1)

Open or close this module Study Identification
Unique Protocol ID: P080205
Brief Title: Medico-economic Evaluation of a Non-chirurgical Pulmonary Valve Replacement (REVALV) (REVALV)
Official Title: Medico-economic Evaluation of a Non-chirurgical Pulmonary Valve Replacement for the Treatment of Lesions of the Ventricular Outflow Tract.
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2010
Overall Status: Recruiting
Study Start: March 2009
Primary Completion: March 2011 [Anticipated]
Study Completion: March 2013 [Anticipated]
First Submitted: November 27, 2010
First Submitted that
Met QC Criteria:
November 29, 2010
First Posted: November 30, 2010 [Estimate]
Last Update Submitted that
Met QC Criteria:
November 29, 2010
Last Update Posted: November 30, 2010 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Assistance Publique - Hôpitaux de Paris
Responsible Party:
Collaborators: Ministry of Health, France
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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).
Detailed Description:

Rational : transcatheter valve insertion is a new technique enlarging the armamentarium of the treatment of RVOT obstruction and insufficiency. It real place as compared to bare stent implantation and surgery of the RVOT remains unknown.

Main objective : evaluate the cost of the procedure as compared with conventional technique.

Design : multicenter intervention prospective study. Population : 180 patients in three arms (3*60).

End point criteria :

  • Primary : cost
  • Secondary : rate of reoperation
Open or close this module Conditions
Conditions: Dysfunction of the Prosthetic Conduct
Lesions of the Right Ventricular Outflow Tract.
Keywords: right ventricular outflow tract
endovascular valve insertion
economic evaluation
valved stent
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 180 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Melody
insertion of a pulmonic valved stent
Device: Melody
insertion of a pulmonic valved stent
Other Names:
  • insertion of a pulmonic valved stent
Active Comparator: Bare stent
insertion of a bare metal stent
Device: bare stent
insertion of a bare metal stent
Other Names:
  • insertion of a bare metal stent
Active Comparator: Surgery
conventional surgery methode.
Procedure: Surgery
conventional surgery methode
Other Names:
  • conventional surgery methode
Open or close this module Outcome Measures
Primary Outcome Measures:
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.
[ Time Frame: 24 months after intervention ]

Secondary Outcome Measures:
1. Quality of life
[ Time Frame: 24 months after intervention ]

2. procedure success rate
[ Time Frame: 24 months after intervention ]

3. Does the patient need to be operated again?
[ Time Frame: 24 months after intervention ]

Open or close this module Eligibility
Minimum Age: 5 Years
Maximum Age: 70 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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
Open or close this module Contacts/Locations
Central Contact Person: Boudjemline Younes, MD, PhD
Telephone: +33 (0)1 44 49 43 47
Email: younes.boudjemline@nck.aphp.fr
Study Officials: Boudjemline Younes, MD, PhD
Principal Investigator
Assistance Publique - Hôpitaux de Paris
Locations: France
Hôpital Necker Enfants Malades
[Recruiting]
Paris, France, 75015
Contact:Contact: Boudjemline Younes, MD, PhD +33 (0)1 44 49 43 47 younes.boudjemline@nck.aphp.fr
Contact:Principal Investigator: Boudjemline Younes, Md, PhD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services