Brief Summary

The purpose of this active post-market surveillance study is to confirm the safety and effectiveness of the EDWARDS INTUITY Valve System in the study population. The objective is to evaluate cardiac performance characteristics and adverse events rates associated with the EDWARDS INTUITY Valve in patients undergoing AVR. The AVR surgical approach is either full or partial sternotomy or a right anterior thoracotomy.

Trial Health

On Track

Trial Health Score

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

Enrollment

516

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Jul 2012

Typical duration for all trials

Geographic Reach

9 countries

27 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

3.8 years study duration

Study Start

First participant enrolled

July 1, 2012

Completed

2.4 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2014

Completed

2 months until next milestone

First Posted

Study publicly available on registry

January 14, 2015

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed

3.5 years until next milestone

Results Posted

Study results publicly available

October 14, 2019

Completed

Last Updated

November 22, 2019

Status Verified

November 1, 2019

Enrollment Period

3.8 years

First QC Date

November 19, 2014

Results QC Date

August 30, 2019

Last Update Submit

November 12, 2019

Conditions

Aortic Valve Disease Aortic Stenosis Rapid Deployment Valves

Keywords

Aortic Valve ReplacementAortic StenosisEDWARDS INTUITY

Outcome Measures

Primary Outcomes (1)

Subject's Average Time Spent on Cardiopulmonary Cross Clamp
Cardiopulmonary cross clamp time is the amount of time that the patient's aorta (blood vessel) is clamped by a surgical instrument used in cardiac surgery. This allows the normal blood flow to be sent to an artificial heart and lung machine to keep it at a constant temperature and oxygen level.
At time of surgery; an average of 1 hour

Other Outcomes (22)

Subject's Average Time Spent on Cardiopulmonary Bypass
At time of surgery; an average of 1.5 hours
Subject's Average Skin-to-skin Time
At time of surgery; an average of 3.5 hours
Subject's Device Technical Success
At time of surgery
+19 more other outcomes

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Adult subjects, age 18 or older, that have been diagnosed with aortic stenosis or stenosis-based insufficiency and are scheduled to undergo surgical aortic valve replacement are eligible for participation in this study. Study subjects shall be drawn from the general patient populations served by each investigational center. Candidates for this study must meet all of the following inclusion criteria and none of the exclusion criteria.

You may qualify if:

Subject is 18 years or older
Subject presents with aortic stenosis or stenosis-based insufficiency of an aortic valve requiring a planned replacement of the native aortic valve or previously implanted aortic prosthesis.
Subject has signed and dated the investigation informed consent forms prior to study-specific procedures are performed.
Subject is geographically stable and agrees to attend follow-up assessments as specified in the protocol and informed consent.

You may not qualify if:

History of active endocarditis within three months of scheduled surgery
Subject is diagnosed with pure aortic insufficiency
Aneurysm of the aortic root and/or ascending aorta

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Edwards Lifescienceslead

Study Sites (27)

Salzburger Universitätsklinikum

Salzburg, 5020, Austria

Location

Landesklinikum - St. Pölten

Sankt Pölten, 3100, Austria

Location

Klinisshe Abteiluing Für Herz-thoraxchirurgie

Vienna, 1090, Austria

Location

Aarhus Universitetshospital Skejby

Aarhus N, 8200, Denmark

Location

CHU Bocage Central Dijon

Dijon, 21074, France

Location

Hôpital Saint Joseph - Marseille

Marseille, 13285, France

Location

Centre Hospitalier de Mulhouse

Mulhouse, 68051, France

Location

Centre Cardiologique du Nord St Denis

Saint-Denis, 93200, France

Location

Herz- und Gefäß-Klinik GmbH Bad Neustadt

Bad Neustadt an der Saale, 97616, Germany

Location

Westdeutsches Herzcentrum Uniklinik Essen

Essen, 45147, Germany

Location

Klinikum Nürnberg Süd

Nürenberg, 90471, Germany

Location

Clinica Santa Maria

Bari, 70124, Italy

Location

S. Anna Hospital

Catanzaro, 88100, Italy

Location

G. Pasquinucci Heart Hospital - "G.Monasterio" Foundation

Massa, 54100, Italy

Location

Centro Cardiologico Monzino

Milan, 20138, Italy

Location

Ospedale Niguarda Ca' Granda

Milan, 20162, Italy

Location

Università Cattolica del Sacro Cuore Policlinico

Roma, 00168, Italy

Location

Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia"

Udine, 33100, Italy

Location

Catharina Hospital Eindhoven

Eindhoven, 5623, Netherlands

Location

Hospital Universitario Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

Location

Hospital Universitario Cruces Barakaldo

Barakaldo, 48903, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Universitätsklinik Für Herz und Gefässchirurgie

Bern, 3010, Switzerland

Location

Cardiocentro Ticino

Lugano, 6903, Switzerland

Location

Universität Zurich

Zurich, 8091, Switzerland

Location

St Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

King's College Hospital

London, SE5 9RS, United Kingdom

Location

Related Publications (1)

Young C, Laufer G, Kocher A, Solinas M, Alamanni F, Polvani G, Podesser BK, Aramendi JI, Arribas J, Bouchot O, Livi U, Massetti M, Terp K, Giot C, Glauber M. One-year outcomes after rapid-deployment aortic valve replacement. J Thorac Cardiovasc Surg. 2018 Feb;155(2):575-585. doi: 10.1016/j.jtcvs.2017.09.133. Epub 2017 Oct 31.
PMID: 29415382RESULT

MeSH Terms

Conditions

Aortic Valve DiseaseAortic Valve Stenosis

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Results Point of Contact

Title: Andrey Nersesov, Sr. Director of Clinical Affairs, Surgical Structural Heart
Organization: Edwards Lifesciences, LLC

Study Officials

Dr. Glauber, MD
Organizational Affiliation: OSPEDALE "G. PASQUINUCCI" CREAS IFC-CNR
PRINCIPAL INVESTIGATOR
Prof.Christopher Young, MD FRCS
Guy's & St Thomas' Hospital
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 19, 2014

First Posted

January 14, 2015

Study Start

July 1, 2012

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

November 22, 2019

Results First Posted

October 14, 2019

Record last verified: 2019-11

Locations

NL(1)ES(3)FR(4)GB(2)DE(3)CH(3)IT(7)DK(1)AU(3)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Other Outcomes (22)

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (27)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations