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Trial record 1 of 1 for:    REVALV
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Medico-economic Evaluation of a Non-chirurgical Pulmonary Valve Replacement (REVALV) (REVALV)

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ClinicalTrials.gov Identifier: NCT01250327
Recruitment Status : Completed
First Posted : November 30, 2010
Last Update Posted : October 18, 2017
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE November 27, 2010
First Posted Date  ICMJE November 30, 2010
Last Update Posted Date October 18, 2017
Study Start Date  ICMJE March 2009
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2010)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2010)
  • Quality of life [ Time Frame: 24 months after intervention ]
  • procedure success rate [ Time Frame: 24 months after intervention ]
  • Does the patient need to be operated again? [ Time Frame: 24 months after intervention ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Medico-economic Evaluation of a Non-chirurgical Pulmonary Valve Replacement (REVALV)
Official Title  ICMJE Medico-economic Evaluation of a Non-chirurgical Pulmonary Valve Replacement for the Treatment of Lesions of the Ventricular Outflow Tract.
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Dysfunction of the Prosthetic Conduct
  • Lesions of the Right Ventricular Outflow Tract
Intervention  ICMJE
  • Device: Melody
    insertion of a pulmonic valved stent
    Other Name: insertion of a pulmonic valved stent
  • Device: bare stent
    insertion of a bare metal stent
    Other Name: insertion of a bare metal stent
  • Procedure: Surgery
    conventional surgery methode
    Other Name: conventional surgery methode
Study Arms  ICMJE
  • Experimental: Melody
    insertion of a pulmonic valved stent
    Intervention: Device: Melody
  • Active Comparator: Bare stent
    insertion of a bare metal stent
    Intervention: Device: bare stent
  • Active Comparator: Surgery
    conventional surgery methode.
    Intervention: Procedure: Surgery
Publications * Fraisse A, Aldebert P, Malekzadeh-Milani S, Thambo JB, Piéchaud JF, Aucoururier P, Chatelier G, Bonnet D, Iserin L, Bonello B, Assaidi A, Kammache I, Boudjemline Y. Melody ® 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 17, 2013)
93
Original Estimated Enrollment  ICMJE
 (submitted: November 29, 2010)
180
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01250327
Other Study ID Numbers  ICMJE P080205
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Assistance Publique - Hôpitaux de Paris
Original Responsible Party Laurent Piazza, Department Clinical Research of developpement
Current Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Ministry of Health, France
Investigators  ICMJE
Principal Investigator: Boudjemline Younes, MD, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP