NCT02777892

Brief Summary

Multi-center, Observational Registry with Retrospective Enrollment and Prospective Follow-up. The aim of the registry is to document the feasibility and safety of implanting an Edwards SAPIEN S3 transcatheter heart valve in the pulmonic position

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2016

Longer than P75 for all trials

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 19, 2016

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

7.1 years

First QC Date

May 12, 2016

Last Update Submit

September 12, 2023

Conditions

Pulmonary Valve MalfunctionRight Ventricular Outflow Tract (RVOT) Dysfunction

Outcome Measures

Primary Outcomes (1)

  • changes in right ventricular and pulmonary artery pressure

    from baseline to 30 days after implantation

Secondary Outcomes (7)

  • Max. flow velocity RVOT

    30 days after implantation

  • Changes in NYHA class

    from baseline to 30 days after implantation

  • changes in degree of pulmonary regurgitation

    from baseline to 30 days after implantation

  • length of hospitalization

    30 days after implantation

  • changes in Peak Oxygen consumption

    from baseline to 24 months after implantation

  • +2 more secondary outcomes

Study Arms (1)

pulmonary valve replacement

SAPIEN S3 Transcatheter Heart Valve in the pulmonic position at the time of data collection

Other: Sapien S3

Interventions

Sapien S3OTHER

Patients that have undergone percutaneous implantation of an Edwards SAPIEN S3 Transcatheter Heart Valve in the pulmonic position at the time of data collection

pulmonary valve replacement

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients that have undergone percutaneous implantation of an Edwards SAPIEN XT Transcatheter Heart Valve in the pulmonic position at the time of data collection

You may qualify if:

  • Clinical indication and decision for the implantation of an Edwards SAPIEN 3 THV made
  • Data release form

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

St Pauls Hospital Vancouver

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Deutsches Herzzentrum München

München, Bavaria, 80636, Germany

Location

Herzchirurgische Klinik und Poliklinik LMU

München, Bavaria, 81377, Germany

Location

Universitätsspital Zürich

Zurich, 8091, Switzerland

Location

Related Links

Study Officials

  • Peter Bramlage, Prof MD

    Institut für Pharmakologie und Präventive Medizin

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2016

First Posted

May 19, 2016

Study Start

March 1, 2016

Primary Completion

March 31, 2023

Study Completion

July 31, 2023

Last Updated

September 13, 2023

Record last verified: 2023-09

Locations

CH(1)CA(1)DE(2)