Transcatheter Valve Implantation in Patients With Dysfunctional Left and Right Sided Heart Valves

NCT02119442 | Completed Results

• 1 other identifier: 13-001008
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

A growing body of data, suggests that transcatheter valves are effective when implanted in other locations (mitral, aortic, tricuspid) and in high pressure environments. The investigators plan to offer transcatheter valve implantation as an alternative to high risk surgery in patients who require revision of a stenotic or regurgitant valve in the non-pulmonary position (mitral, aortic, tricuspid). This therapy can provide an alternative to patients who may be considered high risk and may not be able to survive a surgical procedure.The use of the devices on this protocol are for medical treatment and are not part of a clinical trial.

Conditions

Eisenmenger Syndrome

Keywords

Eisenmenger Syndrome, Pulmonary Arterial Hyptertension

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Developed Infective Endocarditis

  The investigator will be assessing the efficacy of transcatheter heart valve (THV) by evaluating survival and development of infective endocarditis as an adverse event.

  8 years

Study Arms (1)

Transcatheter Valve Implantation

OTHER

Intervention, Transcatheter Valve Implantation with Melody or Sapien bioprosthetic valve Standard of care intervention.

Device: Transcather Valve Implantation

Interventions

Transcather Valve Implantation DEVICE

Transcather Valve Implantation

Also known as: Medtronic Melody Transcatheter Valve; Melody TPV 20 PB1016:Melody TPV 22 PB1018, Edwards SAPIEN Transcatheter Heart Valve

Transcatheter Valve Implantation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will be considered eligible for transcatheter valve implantation if the risk of serious morbidity or mortality with surgical intervention is deemed to be greater than 10 percent by the treating cardiologist and consulting surgeon. The Melody Valve is intended for use in the following clinical conditions:
• Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 mm in diameter when originally implanted, AND
• Dysfunctional RVOT conduits with a clinical indication for intervention, AND EITHER
• Regurgitation ≥ moderate
• Stenosis: mean right ventricular outflow tract gradient ≥ 35 mmHg
• The Edwards Sapien Valve will be used in the aortic position for valves and conduits larger than 23mm in diameter with a landing zone less than 26-27mm, otherwise the melody valve will be considered
• The Edwards Sapien Vavle will also be considered in other positions that have an adequate landing zone and a large enough circumference
• The Melody valve may be utilized outside of its approved indications for valve replacement in high risk surgical patients

You may not qualify if:

• There are no known contraindications for implantation of the Melody Valve or the Edwards Sapien Valve

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

Related Publications (5)

• Kondo N, Shuto T, McGarvey JR, Koomalsingh KJ, Takebe M, Gorman RC, Gorman JH 3rd, Gillespie MJ. Melody valve-in-ring procedure for mitral valve replacement: feasibility in four annuloplasty types. Ann Thorac Surg. 2012 Mar;93(3):783-8. doi: 10.1016/j.athoracsur.2011.12.021.

  PMID: 22364973 BACKGROUND

• Riede FT, Dahnert I. Implantation of a Melody valve in tricuspid position. Catheter Cardiovasc Interv. 2012 Sep 1;80(3):474-6. doi: 10.1002/ccd.23404. Epub 2012 Mar 14.

  PMID: 22105855 BACKGROUND

• Ben-Gal Y, Finkelstein A, Bruckheimer E, Banai S, Keren G, Kramer A, Uretzky G. Transapical implantation of a Melody valve in a degenerated low-diameter prosthetic aortic valve. Circulation. 2013 Apr 23;127(16):e553-6. doi: 10.1161/CIRCULATIONAHA.112.127027. No abstract available.

  PMID: 23609553 BACKGROUND

• Cheung AW, Gurvitch R, Ye J, Wood D, Lichtenstein SV, Thompson C, Webb JG. Transcatheter transapical mitral valve-in-valve implantations for a failed bioprosthesis: a case series. J Thorac Cardiovasc Surg. 2011 Mar;141(3):711-5. doi: 10.1016/j.jtcvs.2010.11.026. Epub 2011 Jan 26.

  PMID: 21269643 BACKGROUND

• Kenny D, Hijazi ZM, Walsh KP. Transcatheter tricuspid valve replacement with the Edwards SAPIEN valve. Catheter Cardiovasc Interv. 2011 Aug 1;78(2):267-70. doi: 10.1002/ccd.23016. Epub 2011 Jul 15.

  PMID: 21766424 BACKGROUND

MeSH Terms

Conditions

Eisenmenger Complex

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Soraya Sadeghi
• Organization: UCLA

smsadeghi@mednet.ucla.edu

3108255950

Study Officials

• Jamil A Aboulhosn, MD, FACC

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Medicine

Study Record Dates

• First Submitted: April 8, 2014
• First Posted: April 21, 2014
• Study Start: August 1, 2013
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: April 30, 2019
• Results First Posted: April 30, 2019

Record last verified: 2019-04

Locations

US (1)