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Evaluation of the GORE PV1 Device in Patients With Pulmonary Valve Dysfunction

Primary Purpose

Heart Defects, Congenital, Tetralogy of Fallot, Pulmonary Valve Insufficiency

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GORE PV1
Sponsored by
W.L.Gore & Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Heart Defects, Congenital

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. A symptomatic or appropriate asymptomatic subject with a native or repaired right ventricular outflow tract requiring reconstruction with a valved conduit
  2. Age ≥5 years at the time of informed consent signature.

Note: Additional Inclusion Criteria may apply

Exclusion Criteria:

  1. An artificial valve at another position or will need an artificial valve at another position (i.e. replacement at the time of index procedure or anticipated within 3 years).
  2. Subjects with previously implanted pacemaker (including defibrillators).
  3. Major or progressive non-cardiac disease (liver failure, renal failure, cancer) that has a life expectancy of less than one year.

Note: Additional Exclusion Criteria may apply

Sites / Locations

  • Lurie Children's Hospital
  • Boston Children's Hospital
  • Nationwide Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

Participants will receive the device on Day 1.

Outcomes

Primary Outcome Measures

Valve-related mortality and device-related re-intervention
The composite of valve-related mortality and device-related re-intervention measured at 6 months post-procedure

Secondary Outcome Measures

MRI change in right ventricular end diastolic volume index
Six month change from baseline in right ventricular end diastolic volume index as measured from Magnetic Resonance Imaging
MRI change in right ventricular end systolic volume index at 6 months
Six month change from baseline in right ventricular end systolic volume index as measured from Magnetic Resonance Imaging
MRI change in left ventricular diastolic volume index at 6 months
Six month change from baseline in left ventricular diastolic volume index as measured from Magnetic Resonance Imaging
MRI change in right ventricular ejection fraction at 6 months
Six month change from baseline in right ventricular ejection fraction index as measured from Magnetic Resonance Imaging
Echo change in right ventricular diastolic area at 12 months
Twelve month change from baseline in right ventricular diastolic area as measured from echocardiography
Echo change in right ventricular systolic area at 12 months
Twelve month change from baseline in right ventricular systolic area as measured from echocardiography
Echo change in left ventricular end diastolic volume index at 12 months
Twelve month change from baseline in left ventricular end diastolic volume index as measured from echocardiography
Echo change in right ventricular fractional area change at 12 months
Twelve month change from baseline in right ventricular fractional area change as measured from echocardiography
Six month mean pressure gradient <= 40 mmHG
Number of subjects with mean pressure gradient across conduit (RV to PA) less than or equal to 40 mmHg at 6 months
Twelve month mean pressure gradient <= 40 mmHG
Number of subjects with mean pressure gradient across conduit (RV to PA) less than or equal to 40 mmHg at 12 months
Six month pulmonary regurgitation < moderate
Number of subjects with pulmonary regurgitation less than moderate at 6 months
Twelve month pulmonary regurgitation < moderate
Number of subjects with pulmonary regurgitation less than moderate at 12 months
Device-related re-intervention at 1, 3, 6, 12, 24, 36, 48, and 60 months
Kaplan-Meier estimates of device-related re-intervention summarized at 1, 3, 6, 12 months, and annually through 5 years
All-cause mortality at 1, 3, 6, 12, 24, 36, 48, and 60 months
Kaplan-Meier estimates of all-cause mortality summarized at 1, 3, 6, 12 months, and annually through 5 years

Full Information

First Posted
February 15, 2018
Last Updated
April 26, 2023
Sponsor
W.L.Gore & Associates
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1. Study Identification

Unique Protocol Identification Number
NCT03441971
Brief Title
Evaluation of the GORE PV1 Device in Patients With Pulmonary Valve Dysfunction
Official Title
Evaluation of the GORE PV1 Device for Replacement of the Pulmonary Valve and Reconstruction of Right Ventricular Outflow Tract
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 7, 2018 (Actual)
Primary Completion Date
April 13, 2020 (Actual)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
W.L.Gore & Associates

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will assess the safety and performance of the GORE PV1 Device for replacement of the pulmonary valve and reconstruction of the Right Ventricular Outflow Tract (RVOT).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Defects, Congenital, Tetralogy of Fallot, Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Experimental
Arm Description
Participants will receive the device on Day 1.
Intervention Type
Device
Intervention Name(s)
GORE PV1
Intervention Description
Implantation of GORE PV1 Device for procedure to replace the pulmonary valve and reconstruct the right ventricular outflow tract (RVOT).
Primary Outcome Measure Information:
Title
Valve-related mortality and device-related re-intervention
Description
The composite of valve-related mortality and device-related re-intervention measured at 6 months post-procedure
Time Frame
6 months
Secondary Outcome Measure Information:
Title
MRI change in right ventricular end diastolic volume index
Description
Six month change from baseline in right ventricular end diastolic volume index as measured from Magnetic Resonance Imaging
Time Frame
6 months
Title
MRI change in right ventricular end systolic volume index at 6 months
Description
Six month change from baseline in right ventricular end systolic volume index as measured from Magnetic Resonance Imaging
Time Frame
6 months
Title
MRI change in left ventricular diastolic volume index at 6 months
Description
Six month change from baseline in left ventricular diastolic volume index as measured from Magnetic Resonance Imaging
Time Frame
6 months
Title
MRI change in right ventricular ejection fraction at 6 months
Description
Six month change from baseline in right ventricular ejection fraction index as measured from Magnetic Resonance Imaging
Time Frame
6 months
Title
Echo change in right ventricular diastolic area at 12 months
Description
Twelve month change from baseline in right ventricular diastolic area as measured from echocardiography
Time Frame
12 months
Title
Echo change in right ventricular systolic area at 12 months
Description
Twelve month change from baseline in right ventricular systolic area as measured from echocardiography
Time Frame
12 months
Title
Echo change in left ventricular end diastolic volume index at 12 months
Description
Twelve month change from baseline in left ventricular end diastolic volume index as measured from echocardiography
Time Frame
12 months
Title
Echo change in right ventricular fractional area change at 12 months
Description
Twelve month change from baseline in right ventricular fractional area change as measured from echocardiography
Time Frame
12 months
Title
Six month mean pressure gradient <= 40 mmHG
Description
Number of subjects with mean pressure gradient across conduit (RV to PA) less than or equal to 40 mmHg at 6 months
Time Frame
6 months
Title
Twelve month mean pressure gradient <= 40 mmHG
Description
Number of subjects with mean pressure gradient across conduit (RV to PA) less than or equal to 40 mmHg at 12 months
Time Frame
12 months
Title
Six month pulmonary regurgitation < moderate
Description
Number of subjects with pulmonary regurgitation less than moderate at 6 months
Time Frame
6 months
Title
Twelve month pulmonary regurgitation < moderate
Description
Number of subjects with pulmonary regurgitation less than moderate at 12 months
Time Frame
12 months
Title
Device-related re-intervention at 1, 3, 6, 12, 24, 36, 48, and 60 months
Description
Kaplan-Meier estimates of device-related re-intervention summarized at 1, 3, 6, 12 months, and annually through 5 years
Time Frame
1, 3, 6, 12, 24, 36, 48, and 60 months
Title
All-cause mortality at 1, 3, 6, 12, 24, 36, 48, and 60 months
Description
Kaplan-Meier estimates of all-cause mortality summarized at 1, 3, 6, 12 months, and annually through 5 years
Time Frame
1, 3, 6, 12, 24, 36, 48, and 60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A symptomatic or appropriate asymptomatic subject with a native or repaired right ventricular outflow tract requiring reconstruction with a valved conduit Age ≥5 years at the time of informed consent signature. Note: Additional Inclusion Criteria may apply Exclusion Criteria: An artificial valve at another position or will need an artificial valve at another position (i.e. replacement at the time of index procedure or anticipated within 3 years). Subjects with previously implanted pacemaker (including defibrillators). Major or progressive non-cardiac disease (liver failure, renal failure, cancer) that has a life expectancy of less than one year. Note: Additional Exclusion Criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro del Nido, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lurie Children's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of the GORE PV1 Device in Patients With Pulmonary Valve Dysfunction

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