EDWARDS INTUITY Elite Valve System

NCT02907463 | Completed Results DMC

• 1 other identifier: 2015-05
• Study Type: observational
• Target: 280
• Locations: 9 countries
• Sites: 23

Brief Summary

The purpose of this active, observational, open-label, non-randomized, post-market surveillance study is to confirm that EDWARDS INTUITY Elite reduces cross clamp time (XCT) in MIS setting when compared to published data with a conventional valve within the MIS setting. The published dataset will used as a control group. Then to describe short term (30 days) and long term (6 months) clinical safety, to assess and compare hemodynamic data with EDWARDS INTUITY Elite to a conventional valve at discharge and at 6 months post AVR, to assess Quality of Life at baseline, and at 6 months post AVR to assess NYHA functional class at baseline, discharge, 1 month and at 6 months post AVR to assess Fitness for hospital discharge.

Conditions

Aortic Valve Disease; Aortic Stenosis

Keywords

Aortic Valve Replacement; Aortic Stenosis; EDWARDS INTUITY Elite; Rapid deployment valves

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

Secondary Outcomes (14)

• Subject's Average Time Spent on Cardiopulmonary Bypass.

  At time of surgery; an average of 1.5 hours

• Device Technical Success Rate

  At time of surgery

• First Attempt Success Rate

  At time of surgery

• Procedural Success

  Day of procedure and events occurring within 10 days of procedure

• Subject's Average Health Care Utilization

  Day of surgical procedure through discharge from the hospital, an average of 3 days and 10 days respectively.

Other Outcomes (7)

• Subject's Average SF-36 Physical Health Summary

  Baseline and 6 months

• Subject's Average SF-36 Mental Health Summary

  Baseline and 6 months

• Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline

  6 months compared to baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Adult subjects, age18 or older, that have been diagnosed with aortic stenosis or stenosis-based insufficiency requiring isolated aortic valve replacement (AVR) * Subjects whose medical records indicate they are a suitable candidate for Minimally Invasive Surgery (MIS) * Subjects whose treating physician is the Principle Investigator or a Sub-Investigator participating in the study and has been trained on the EDWARDS INTUITY Elite Valve System * Subject shall be drawn from the general patient population served by each investigational center * Candidates for this study must meet all of the following Inclusion criteria and none of the Exclusion criteria or intra-op exclusion criteria

You may qualify if:

• Subject is 18 years or older
• Subject is symptomatic for aortic stenosis (AS) or mixed aortic stenosis and aortic insufficiency (AS/AI) disease for which isolated surgical aortic valve replacement without concomitant procedures is indicated according to International guidelines.
• Surgery starts with and is intended to be completed via a minimal invasive surgical approach. MIS is defined as a non-full sternotomy approach such as partial hemi-sternotomy, right anterior thoracotomy.
• Surgery is intended to be completed with an EDWARDS INTUITY Elite Heart Valve.
• Subject has signed and dated the investigation informed consent forms prior to any 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:

• Subject is diagnosed with pure aortic insufficiency.
• Subject requires multiple valve replacement/repair
• Subject has Type 0 congenital true bicuspid aortic valve (i.e. absence of raphe and commissures are positioned about 180 degrees apart) or unicuspid aortic valve.
• Subject has severe ventricular dysfunction defined as LVEF \< 25%.
• Subject has a history of active endocarditis and/or myocarditis ≤ 3 months before the intended treatment/scheduled surgery.
• Subject has had an acute MI ≤ 3 months before the intended treatment.
• Subject had a stroke or transient ischemic attack within six months prior to scheduled aortic valve replacement surgery.
• Subject is oxygen or ventilator dependent.
• Subject has life expectancy \< 12 months.
• Female subject is pregnant or lactating.
• Subject with documented leukopenia (WBC \< 3.5x 103/μL), anemia (Hb \< 10.0 gm/dL or \< 6.2 mmol/L), thrombocytopenia (platelet count \< 100x 103/mL), or history of bleeding diathesis or coagulopathy.
• Subject has renal insufficiency as determined by Serum creatinine
• ≥ 200 μmol/L (2.27 mg/dL) at screening or end-stage renal disease requiring chronic dialysis.
• Subject is currently participating in an investigational drug or device trial for which follow-up has not yet been completed.
• Minimally Invasive access to the heart is not possible due to anatomical constraints or any other pre-existing condition.

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (23)

Universitätsklinik für Herzchirurgie Medizinische Universität Innsbruck

Innsbruck, 6020, Austria

Location

Klinisshe Abteiluing Für Herz-thoraxchirurgie

Vienna, 1090, Austria

Location

Aarhus Universitets Hospital Skejby

Aarhus N, 8200, Denmark

Location

CHU Bocage Central Dijon

Dijon, 21074, France

Location

Hôpital Cardiologique CHU Bordeaux Haut Leveque

Pessac, 33 604, France

Location

Herz- und Gefäß-Klinik GmbH Bad Neustadt

Bad Neustadt an der Saale, 97616, Germany

Location

Universitätsklinikum der Ruhr-Universität Bochum Klinik für Herz- und Thoraxchirurgie

Bochum, 44789, Germany

Location

Herzzentrum Uniklinik Köln

Cologne, 50924, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Herzzentrum Leipzig

Leipzig, 04289, Germany

Location

University Hospital Würzburg

Würzburg, 97080, Germany

Location

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

Massa, 54100, Italy

Location

CentroCardiologico Monzino

Milan, 20138, Italy

Location

Clinica San Gaudenzio

Novara, Italy

Location

Università Cattolica del Sacro Cuore Policlinico

Roma, 00168, Italy

Location

Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia"

Udine, 33100, Italy

Location

Institut National de Chirurgie Cardiaque et Cardiologie Interventionnelle (INCCI)

Luxembourg, 1210, Luxembourg

Location

St Antonius Hospital

Nieuwegein, 3430 EM / PO BOX 2500, Netherlands

Location

Hospital Universitario Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

Location

Complexo Hospitalario Universitario A Coruna

A Coruña, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Royal Infirmary Hospital Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Location

St Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

Related Publications (1)

• Laufer G, Strauch JT, Terp KA, Salinas M, Arribas JM, Massetti M, Andreas M, Young CP. Real-world 6-month outcomes of minimally invasive aortic valve replacement with the EDWARDS INTUITY Elite valve system. Interact Cardiovasc Thorac Surg. 2022 Jul 9;35(2):ivac083. doi: 10.1093/icvts/ivac083.

  PMID: 35394527 DERIVED

MeSH Terms

Conditions

Aortic Valve Disease; Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Results Point of Contact

• Title: Mary Edwards, VP Clinical and Regulatory Affairs, Surgical Structural Heart
• Organization: Edwards Lifesciences, LLC

mary_edwards@edwards.com

949-250-2500

Study Officials

• Christopher Young, MD FRCS

  St. Thomas' Hospital

  PRINCIPAL INVESTIGATOR

• Gunther Laufer, Prof. Dr. med

  AKH Vienna Dep. of Cardiovascular Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: September 20, 2016
• Study Start: February 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: December 1, 2017
• Last Updated: November 22, 2019
• Results First Posted: November 8, 2019

Record last verified: 2019-11

Locations

DK (1); NL (1); GB (2); AU (2); DE (6); ES (3); FR (2); IT (5); LU (1)