Novel Venous Cannula Trial

NCT07087639 | Completed

• 1 other identifier: DE-51-20
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, open-label, single-arm, single-center clinical investigation designed to evaluate the safety and performance of a Novel Venous Cannula during on-pump cardiac surgery requiring transfemoral venous cannulation. The investigation aims to assess the pressure drop across the cannula during extracorporeal circulation and the incidence of serious adverse events associated with its use. A total of 42 participants will be enrolled.

Conditions

Cardiac Surgery; Heart Surgery; Cardiopulmonary Bypass; Minimally Invasive Surgical Procedures

Keywords

Venous Cannula; Extracorporeal Circulation; Cardiopulmonary Bypass; Cardiac Surgery; Transfemoral Venous Cannulation; Minimally Invasive Cardiac Surgery (MICS); Medical Device; Pressure Drop; Serious Adverse Events (SAE); Device Safety; Device Performance; Open-label Clinical Trial; Single-arm Study; Monocentric Study; Self-expanding Cannula

Outcome Measures

Primary Outcomes (2)

• Effectiveness: the mean pressure drop (mm Hg) to maintain the desired flow rate (L/min) during the standard surgical procedure

  Measurement of the mean pressure drop (in millimeters of mercury, mmHg) across the novel venous cannula required to maintain the target blood flow rate (liters per minute) during cardiopulmonary bypass in cardiac surgery patients.

  During the surgical procedure (Day 0)

• Safety: the number of SAE with the Novel Venous Cannula during the standard surgical procedure

  Number of serious adverse events (SAEs) occurring during the surgical procedure that are related or possibly related to the use of the novel venous cannula, including device-related complications, cardiovascular events, and other procedure-associated serious adverse events.

  From Day 0 (procedure day) to 7 days post-procedure

Secondary Outcomes (19)

• Venous Line Flow During Extracorporeal Circulation Unit of Measure: mL/min

  During the surgical procedure (Day 0)

• Mean pump flow during extracorporeal circulation Unit of Measure: L/min/m²

  During the surgical procedure (Day 0)

• Number of cannulae in the surgical field during surgical procedure Unit of Measure: Count (number)

  During the surgical procedure (Day 0)

• Number of cannula tip displacement as detected by TTE/TEE during surgical procedure Unit of Measure: n (%)

  During the surgical procedure (Day 0)

• Mean increase in free Hb measure during surgical procedure Unit of Measure: mg/dL

  During the surgical procedure (Day 0)

Study Arms (1)

Experimental Arm - Novel Self-expanding Venous Cannula

EXPERIMENTAL

Participants in this arm will undergo transfemoral venous cannulation using the Novel Self-expanding Venous Cannula during on-pump cardiac surgery procedures. The investigational device is a single-use, sterile polyurethane cannula reinforced with a flexible metallic mesh that allows self-expansion once deployed into the vessel. The device is intended to facilitate efficient venous drainage as part of the extracorporeal circulation system. The study aims to evaluate the device's performance in terms of pressure drop and safety profile.

Device: Self-expanding Venous Cannula

Interventions

Self-expanding Venous Cannula DEVICE

The intervention consists of a self-expanding venous drainage cannula made of polyurethane and reinforced with a flexible metallic mesh. It is designed for transfemoral insertion during on-pump cardiac surgery, including minimally invasive procedures. Once positioned, the cannula expands to its functional diameter to facilitate efficient blood drainage into the extracorporeal circulation system. The configuration used in this study is 680/730 mm in length, 24 Fr, 3/8" diameter. The device is sterile, single-use, and is inserted once on the day of surgery (Day 0) and removed at the end of the procedure. The cannula is used continuously during cardiopulmonary bypass for a maximum duration of 6 hours and is not reused.

Experimental Arm - Novel Self-expanding Venous Cannula

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years
• Informed consent obtained
• Hospitalised patients undergoing transfemoral venous cannulation for on pump cardiac surgery procedure

You may not qualify if:

• Active bleeding
• Need of ECLS
• Low platelet count (\<150,000)
• Any clinical conditions that contra-indicate the anti-coagulation
• Any clinical condition that, in the opinion of the investigator, may interfere with the procedure
• Subjects participating in any other clinical trial or investigation with a medical device within 3 months before Assessment visit

Sponsors & Collaborators

• Eurosets S.r.l.: lead

Study Sites (1)

Maria Cecilia Hospital

Cotignola, RA, 48033, Italy

Location

Related Publications (18)

• Von Segesser. Venous drainage is key for CPB. The royal Society of Medicine, London. 28th November 2008

  BACKGROUND

• von Segesser LK, Ferrari E, Delay D, Maunz O, Horisberger J, Tozzi P. Routine use of self-expanding venous cannulas for cardiopulmonary bypass: benefits and pitfalls in 100 consecutive cases. Eur J Cardiothorac Surg. 2008 Sep;34(3):635-40. doi: 10.1016/j.ejcts.2008.05.037. Epub 2008 Jul 16.

  PMID: 18635371 BACKGROUND

• Van Praet KM, Kofler M, Meyer A, Sundermann SH, Hommel M, Falk V, Kempfert J. Single-Center Experience With a Self-Expandable Venous Cannula During Minimally Invasive Cardiac Surgery. Innovations (Phila). 2022 Nov-Dec;17(6):491-498. doi: 10.1177/15569845221131534. Epub 2022 Oct 30.

  PMID: 36314445 BACKGROUND

• Stoney WS. Evolution of cardiopulmonary bypass. Circulation. 2009 Jun 2;119(21):2844-53. doi: 10.1161/CIRCULATIONAHA.108.830174. No abstract available.

  PMID: 19487602 BACKGROUND

• Savini C, Gliozzi G, Martin-Suarez S, Zardin D, Mariani C, Cavalli GG, Folesani G, Pacini D. Femoral Venous Cannulation for Minimally Invasive Surgery: Three Years Experience with Wall-less, Self-expandable Cannula. The International Society for Minimally Invasive Cardiothoracic Surgery 2021, PC110.

  BACKGROUND

• Pinon M, Pradas G, Molina D, Legarra JJ. Use of self-expanding venous cannula in tricuspid reoperation. Eur J Cardiothorac Surg. 2015 Sep;48(3):499-501. doi: 10.1093/ejcts/ezu492. Epub 2015 Jan 9.

  PMID: 25575788 BACKGROUND

• Mueller XM, Mallabiabrena I, Mucciolo G, von Segesser LK. Optimized venous return with a self-expanding cannula: from computational fluid dynamics to clinical application. Interact Cardiovasc Thorac Surg. 2002 Sep;1(1):23-7. doi: 10.1016/s1569-9293(02)00006-3.

  PMID: 17669950 BACKGROUND

• Puis L, Milojevic M, Boer C, De Somer FMJJ, Gudbjartsson T, van den Goor J, Jones TJ, Lomivorotov V, Merkle F, Ranucci M, Kunst G, Wahba A; EACTS/EACTA/EBCP Committee Reviewers. 2019 EACTS/EACTA/EBCP guidelines on cardiopulmonary bypass in adult cardiac surgery. Interact Cardiovasc Thorac Surg. 2020 Feb 1;30(2):161-202. doi: 10.1093/icvts/ivz251. No abstract available.

  PMID: 31576402 BACKGROUND

• Jegger D, Chassot PG, Bernath MA, Horisberger J, Gersbach P, Tozzi P, Delay D, von Segesser LK. A novel technique using echocardiography to evaluate venous cannula performance perioperatively in CPB cardiac surgery. Eur J Cardiothorac Surg. 2006 Apr;29(4):525-9. doi: 10.1016/j.ejcts.2005.12.050. Epub 2006 Feb 14.

  PMID: 16476552 BACKGROUND

• Jegger D, Horisberger J, Boone Y, Seigneuil I, Jachertz M, Holzmann I, von Segesser LK. Vascular access for cardiopulmonary bypass procedures. Artif Organs. 2004 Jul;28(7):649-54. doi: 10.1111/j.1525-1594.2004.07372.x.

  PMID: 15209858 BACKGROUND

• Jegger D, Corno AF, Mucciolo A, Mucciolo G, Boone Y, Horisberger J, Seigneul I, Jachertz M, von Segesser LK. A prototype paediatric venous cannula with shape change in situ. Perfusion. 2003 Mar;18(1):61-5. doi: 10.1191/0267659103pf640oa.

  PMID: 12705652 BACKGROUND

• Ismail A, Semien G, Sharma S, Collier SA, Miskolczi SY. Cardiopulmonary Bypass. 2024 Aug 12. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482190/

  PMID: 29489210 BACKGROUND

• Gravlee GP, Davis RF, Kurusz M, Utley JR. Cardiopulmonary Bypass. 2nd Edition. Eugene A, Hessel II, Aaron G. Hill. Chapter 5: circuitry and cannulation - 2016

  BACKGROUND

• Frederick A, Hensley Jr, Martin DE, Gravlee G. A Practical Approach to Cardiac Anesthesia. 3rd Edition. 2011; Larach DR, Gibbs NM. Chapter 7. Anesthetic Management During Cardiopulmonary Bypass

  BACKGROUND

• Hessel EA 2nd. A Brief History of Cardiopulmonary Bypass. Semin Cardiothorac Vasc Anesth. 2014 Jun;18(2):87-100. doi: 10.1177/1089253214530045. Epub 2014 Apr 10.

  PMID: 24728884 BACKGROUND

• Ceresa F, Mammana LF, Leonardi A, Palermo A, Patane F. Virtually Wall-Less versus Standard Thin-Wall Venous Cannula in the Minimally Invasive Mitral Valve Surgery: Single-Center Experience. Medicina (Kaunas). 2023 Jun 29;59(7):1221. doi: 10.3390/medicina59071221.

  PMID: 37512033 BACKGROUND

• Ferrari E, von Segesser LK, Berdajs D, Muller L, Halbe M, Maisano F. Clinical Experience in Minimally Invasive Cardiac Surgery With Virtually Wall-Less Venous Cannulas. Innovations (Phila). 2018 Mar/Apr;13(2):104-107. doi: 10.1097/IMI.0000000000000478.

  PMID: 29677020 BACKGROUND

• Abdel-Sayed S, Favre J, Horisberger J, Taub S, Hayoz D, von Segesser LK. New bench test for venous cannula performance assessment. Perfusion. 2007 Nov;22(6):411-6. doi: 10.1177/0267659108089759.

  PMID: 18666745 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Open-label
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, non-randomized, monocentric, one arm clinical investigation with pre-marked medical device

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 28, 2025
• Study Start: December 22, 2022
• Primary Completion: February 5, 2025
• Study Completion: February 5, 2025
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: IPD and supporting information will be available starting 6 months after publication of the primary study results, and will remain accessible for 5 years thereafter.
• Access Criteria: De-identified individual participant data (IPD) and supporting documents (such as study protocol, statistical analysis plan, and clinical study report) will be available to qualified researchers upon reasonable request. Requestors must submit a research proposal describing the intended use of the data. Access will be granted after approval by the Sponsor to ensure compliance with ethical standards and data protection regulations, including GDPR. Data will be shared through a secure data-sharing platform or via encrypted transfer under a data use agreement that protects participant confidentiality and limits use to the approved research purposes.

Locations

IT (1)