Clinical Evaluation of a Modular Extracorporeal Circulation Circuit

NCT02000544 | Completed

• 1 other identifier: MiECC MODULAR
• Study Type: interventional
• Target: 403
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical research study is the design of a novel modular hybrid system extracorporeal circulation circuit for open heart procedures that could easily be converted from a closed to a semi-closed circuit according to the indication. This could expand the potential of minimal extracorporeal circulation and could ultimately become the new standard circuit in performing every type of cardiac surgery.

Conditions

Coronary Artery Disease; Aortic Valve Disease; Mitral Valve Disease; Aortic Aneurysm

Keywords

Extracorporeal Circulation; Cardiopulmonary Bypass; Cardiac surgery

Outcome Measures

Primary Outcomes (1)

• Rate of conversion to an open circuit

  Conversion rate from closed type-III MiECC to an open circuit

  Intraoperartive

Study Arms (1)

Modular Cardiopulmonary Bypass Circuit

OTHER

Patients undergoing open heart surgery with a modular hybrid extracorporeal circulation circuit.

Device: Modular Cardiopulmonary Bypass Circuit

Interventions

Modular Cardiopulmonary Bypass Circuit DEVICE

Open heart surgery with a novel hybrid modular extracorporeal circulation circuit which is a closed cardiopulmonary bypass circuit with enhanced safety as it can be instantly converted to an open circuit.

Modular Cardiopulmonary Bypass Circuit

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any heart disease that requires open heart surgery under extracorporeal circulation

You may not qualify if:

• Beating heart surgery
• Age more than 80 years

Sponsors & Collaborators

• AHEPA University Hospital: lead

Study Sites (1)

AHEPA University Hospital

Thessaloniki, Greece

Location

Related Publications (9)

• Anastasiadis K, Fragoulakis V, Antonitsis P, Maniadakis N. Coronary artery bypass grafting with minimal versus conventional extracorporeal circulation; an economic analysis. Int J Cardiol. 2013 Oct 15;168(6):5336-43. doi: 10.1016/j.ijcard.2013.08.006. Epub 2013 Aug 15.

  PMID: 23992927 BACKGROUND

• Anastasiadis K, Asteriou C, Antonitsis P, Argiriadou H, Grosomanidis V, Kyparissa M, Deliopoulos A, Konstantinou D, Tossios P. Enhanced recovery after elective coronary revascularization surgery with minimal versus conventional extracorporeal circulation: a prospective randomized study. J Cardiothorac Vasc Anesth. 2013 Oct;27(5):859-64. doi: 10.1053/j.jvca.2013.01.010. Epub 2013 Jun 18.

  PMID: 23791499 BACKGROUND

• Asteriou C, Antonitsis P, Argiriadou H, Deliopoulos A, Konstantinou D, Foroulis C, Papakonstantinou C, Anastasiadis K. Minimal extracorporeal circulation reduces the incidence of postoperative major adverse events after elective coronary artery bypass grafting in high-risk patients. A single-institutional prospective randomized study. Perfusion. 2013 Jul;28(4):350-6. doi: 10.1177/0267659113479135. Epub 2013 Mar 21.

  PMID: 23520169 BACKGROUND

• Anastasiadis K, Antonitsis P, Haidich AB, Argiriadou H, Deliopoulos A, Papakonstantinou C. Use of minimal extracorporeal circulation improves outcome after heart surgery; a systematic review and meta-analysis of randomized controlled trials. Int J Cardiol. 2013 Apr 5;164(2):158-69. doi: 10.1016/j.ijcard.2012.01.020. Epub 2012 Feb 8.

  PMID: 22325958 BACKGROUND

• Anastasiadis K, Antonitsis P, Argiriadou H, Khayat A, Papakonstantinou C, Westaby S. Use of minimal extracorporeal circulation circuit for left ventricular assist device implantation. ASAIO J. 2011 Nov-Dec;57(6):547-9. doi: 10.1097/MAT.0b013e318232d5d5.

  PMID: 21970982 BACKGROUND

• Anastasiadis K, Chalvatzoulis O, Antonitsis P, Deliopoulos A, Argiriadou H, Karapanagiotidis G, Kambouroglou D, Papakonstantinou C. Use of minimized extracorporeal circulation system in noncoronary and valve cardiac surgical procedures-a case series. Artif Organs. 2011 Oct;35(10):960-3. doi: 10.1111/j.1525-1594.2010.01183.x. Epub 2011 Apr 19.

  PMID: 21501191 BACKGROUND

• Anastasiadis K, Argiriadou H, Kosmidis MH, Megari K, Antonitsis P, Thomaidou E, Aretouli E, Papakonstantinou C. Neurocognitive outcome after coronary artery bypass surgery using minimal versus conventional extracorporeal circulation: a randomised controlled pilot study. Heart. 2011 Jul;97(13):1082-8. doi: 10.1136/hrt.2010.218610. Epub 2011 Feb 28.

  PMID: 21357641 BACKGROUND

• Anastasiadis K, Westaby S, Antonitsis P, Argiriadou H, Karapanagiotidis G, Pigott D, Papakonstantinou C. Minimal extracorporeal circulation circuit standby for "off-pump" left ventricular assist device implantation. Artif Organs. 2010 Dec;34(12):1156-8. doi: 10.1111/j.1525-1594.2009.00983.x.

  PMID: 20545669 BACKGROUND

• Anastasiadis K, Asteriou C, Deliopoulos A, Argiriadou H, Karapanagiotidis G, Antonitsis P, Grosomanidis V, Misias G, Papakonstantinou C. Haematological effects of minimized compared to conventional extracorporeal circulation after coronary revascularization procedures. Perfusion. 2010 Jul;25(4):197-203. doi: 10.1177/0267659110373840. Epub 2010 Jun 1.

  PMID: 20515982 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Aortic Valve Disease; Aortic Aneurysm

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Heart Valve Diseases; Aneurysm; Aortic Diseases

Study Officials

• Kyriakos Anastasiadis, MD, DSc, FETCS

  AHEPA University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Kyriakos Anastasiadis

Study Record Dates

• First Submitted: October 6, 2013
• First Posted: December 4, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 12, 2021

Record last verified: 2021-01

Locations

GR (1)