NCT01356108

Brief Summary

The purpose of this registry is to retrospectively and prospectively obtain clinical data in consecutively treated patients, in order to demonstrate that the commercially available Edwards SAPIEN Valve with the RF3 delivery system is a safe and effective treatment for patients with pulmonary regurgitation or stenosis.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
127

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
9 countries

16 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

January 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 19, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2017

Completed
Last Updated

November 20, 2018

Status Verified

November 1, 2018

Enrollment Period

2.5 years

First QC Date

May 17, 2011

Last Update Submit

November 16, 2018

Conditions

Pulmonary RegurgitationPulmonary InsufficiencyPulmonary Stenosis

Keywords

ConduitPulmonicStenosisRegurgitationDysfunctional

Outcome Measures

Primary Outcomes (1)

  • Safety

    Procedure/Device Success and Freedom from device or procedure related death

    6 months

Secondary Outcomes (1)

  • Safety and Effectiveness

    6 Months

Interventions

Transcatheter Pulmonic Valve Replacement (TPVR) (Edwards SAPIEN™ THV)DEVICE

The Edwards SAPIEN™ THV is a biological heart valve manufactured with treated bovine pericardial tissue that is mounted into a balloon expandable stainless steel open cell stent. The Edwards SAPIEN™ THV is available in two sizes (23 and 26mm) and is designed for transcatheter implantation in patients with regurgitant pulmonary valved conduit with or without stenosis. This device is commercially available and is used according the current IFU.

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All symptomatic patients with a regurgitant or stenotic pulmonary valved conduit treated by implantation of the Edwards SAPIEN™ THV.

You may qualify if:

  • \- Symptomatic with a regurgitant or stenotic pulmonary valved conduit.

You may not qualify if:

  • Angiographic evidence of coronary artery compression.
  • RV-PA pulmonary conduit size that is either too large or too small to accommodate the SAPIEN THV.
  • Thrombus or intracardiac mass in the right atrium, right ventricle, and/or pulmonic valve.
  • Severe coagulation problems and/or unable to tolerate anticoagulation/antiplatelet therapy.
  • Active bacterial endocarditis or other active infections.
  • Illeofemoral venous stenosis that may prevent the placement of the introducer sheath and/or central venous vascular tortuosities that may prevent advancement of the delivery system to the heart or into the pulmonary artery.
  • Presence of any prosthetic valve in the tricuspid position.
  • Unstable coronary artery disease-related angina.
  • Placement of the SAPIEN THV in pregnant females.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

University Hospital Leuven

Leuven, 3000, Belgium

Location

Herz und Diabeteszentrum NRW

Bad Oeynhausen, 32545, Germany

Location

German Heart Institute Berlin

Berlin, Germany

Location

Deutsches Herzzentrum München

München, 80636, Germany

Location

Universitätsklinikum Münster

Münster, 48149, Germany

Location

Mater Misericordiae University Hospital

Dublin, Ireland

Location

Schneider Children's Medical Center of Israel

Petach Tikvah, 49202, Israel

Location

Ospedale Bambino Gesù

Rome, RM 00165, Italy

Location

Policlinico San Donato

San Donato Milanese, 20097, Italy

Location

The Cardinal Stefan Wyszyński Institute of Cardiology

Warsaw, 04-628, Poland

Location

King Faisal Specialist Hospital & Research Centre

Riyadh, 11211, Saudi Arabia

Location

Prince Sultan Cardiac Centre

Riyadh, 11625, Saudi Arabia

Location

Mehmet Akif Ersoy Thoracic & Cardiovascular Surgery

Istanbul, 34303, Turkey (Türkiye)

Location

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

The Heart Hospital

London, W1G 8PH, United Kingdom

Location

Manchester Royal Infirmary

Manchester, M139WL, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Valve InsufficiencyRespiratory InsufficiencyPulmonary Valve StenosisConstriction, PathologicGastroesophageal Reflux

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular DiseasesRespiration DisordersRespiratory Tract DiseasesVentricular Outflow ObstructionPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Peter Ewert, MD

    Deutsches Herzzentrum München

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2011

First Posted

May 19, 2011

Study Start

January 1, 2011

Primary Completion

July 1, 2013

Study Completion

December 19, 2017

Last Updated

November 20, 2018

Record last verified: 2018-11

Locations

SA(2)DE(4)TU(1)IT(2)GB(3)IE(1)PL(1)IL(1)BE(1)