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Cardiac SurgeryNCT07087639

Novel Venous Cannula Trial

A study testing Self-expanding Venous Cannula in people with Cardiac Surgery and Heart Surgery, run by Eurosets S.r.l. at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Self-expanding Venous Cannula
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteItaly
Study dates
22 Dec 2022to 5 Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Maria Cecilia Hospital

    Cotignola, RA, 48033

Other trials in Italy

About this study

Official title: Safety and Effectiveness Evaluation of Novel MICS Venous Cannula

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.

Read the detailed description

This clinical investigation evaluates a Novel Venous Cannula intended for drainage of venous blood during extracorporeal circulation in cardiac surgery. The cannula is made of polyurethane and includes a flexible metallic mesh that allows it to collapse during insertion and expand in situ. It is designed for single use, sterile, and is introduced using a dedicated insertion kit.

The study is a non-randomized, open-label, monocentric, single-arm investigation involving 42 adult patients undergoing elective cardiac surgery requiring transfemoral venous cannulation. The investigation includes three visits: a screening visit (from Day -7 to Day -1), the procedure day (Day 0), and a follow-up visit at Day 7 ± 3 days.

The primary effectiveness outcome is the mean pressure drop (mm Hg) across the cannula required to maintain the target flow rate during surgery. The primary safety outcome is the number of serious adverse events (SAEs) related to the use of the investigational device.

Secondary outcomes include several efficacy-related parameters (e.g., venous line flow, pump flow, cannula positioning, volume of infusion, cardioplegic solution usage, and others), as well as safety outcomes including mortality, cardiovascular events, and neurological complications at 7 days post-procedure.

There is no control group in this study.

Being tested
Self-expanding Venous Cannula
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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Self-expanding Venous CannulaDevice

    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.

Study groups in NCT07087639
Study groupRoleWhat they receive
Experimental Arm - Novel Self-expanding Venous CannulaExperimentalParticipants 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.
Receives: Device: Self-expanding Venous Cannula

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: During the surgical procedure (Day 0)

  2. 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.

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

Secondary outcomes (19)

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

    Measurement of venous line flow during CPB to assess the drainage efficiency of the novel venous cannula.

    Measured: During the surgical procedure (Day 0)

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

    Mean Pump Flow Indexed to Body Surface Area During CPB

    Measured: During the surgical procedure (Day 0)

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

    Number of Cannulae Positioned in the Surgical Field

    Measured: During the surgical procedure (Day 0)

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

    Number of Cannula Tip Displacements Detected by TTE/TEE

    Measured: During the surgical procedure (Day 0)

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

    Mean Increase in Free Hemoglobin Levels

    Measured: During the surgical procedure (Day 0)

  6. Mean volume of infusion during surgical procedure Unit of Measure: mL

    Mean Volume of Infusion Administered

    Measured: During the surgical procedure (Day 0)

  7. Mean volume of cardioplegic solution Unit of Measure: mL

    Mean Volume of Cardioplegic Solution Administered

    Measured: During the surgical procedure (Day 0)

  8. Mean speed of aspirators during surgical procedure Unit of Measure: mL/min

    Mean Speed of Aspirators Used

    Measured: During the surgical procedure (Day 0)

  9. Mean percentage of pump flow increase due to the patient's metabolic needs Unit of Measure: %

    Mean Percentage Increase in Pump Flow Due to Metabolic Needs

    Measured: During the surgical procedure (Day 0)

  10. Mean volume of recovery blood re-administered during surgical procedure Unit of Measure: mL

    Mean Volume of Recovery Blood Re-Administered

    Measured: During the surgical procedure (Day 0)

  11. Number of patients for whom blood concentrator was used Unit of Measure: Count (number of patients)

    Number of Patients for Whom a Blood Concentrator Was Used

    Measured: During the surgical procedure (Day 0)

  12. Presence of echocardiographic abnormalities Unit of Measure: n (%)

    Presence of echocardiographic abnormalities

    Measured: During the surgical procedure (Day 0)

  13. Number of correctly delivery and deployed Novel Venous Cannula Unit of Measure: Count (number of cannulae)

    Number of Novel Venous Cannulae Correctly Delivered and Deployed

    Measured: During the surgical procedure (Day 0)

  14. Number of technical success without procedural SAE Unit of Measure: n (%)

    Number of patients in which the device was used successfully without the occurrence of procedural serious adverse events during the procedure.

    Measured: During the surgical procedure (Day 0)

  15. Number of deaths at 7 days after procedure Unit of Measure: Count (number of patients)

    Number of patients who die within 7 days following the surgical procedure involving the use of the novel venous cannula.

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

  16. Number of cardiovascular deaths at 7 days after procedure Unit of Measure: Count (number of patients)

    Number of patients who experience cardiovascular-related death within 7 days following the surgical procedure.

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

  17. Number of cardiovascular SAEs at 7 days after procedure Unit of Measure: Count (number of patients)

    Number of cardiovascular-related serious adverse events (SAEs) occurring within 7 days after the procedure.

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

  18. Number of stroke at 7 days after procedure Unit of Measure: Count (number of patients)

    Number of patients experiencing a clinically confirmed stroke within 7 days following the procedure.

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

  19. Number minor neurological disorder at 7 days after procedure Unit of Measure: Count (number of patients)

    Number of patients experiencing minor neurological disorders within 7 days following the procedure.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2025
  2. Study start22 Dec 2022
  3. Primary completion5 Feb 2025
  4. Study completion5 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Open-label, non-randomized, monocentric, one arm clinical investigation with pre-marked medical device
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07087639
Sponsor's protocol ID
DE-51-20
Status last verified
Jul 2025
First submitted
7 Jul 2025
Last updated
28 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) may be made available to qualified researchers upon reasonable request to the Sponsor, after study completion and publication of the primary results. Each request will be reviewed on a case-by-case basis in accordance with applicable data protection laws, including the EU General Data Protection Regulation (GDPR) 2016/679, and ethical considerations. Access will be granted through a controlled process to ensure the protection of participant confidentiality.

Publications

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

  • 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.

    PubMed 18635371

  • 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.

    PubMed 36314445

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

    PubMed 19487602

  • 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.

  • 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.

    PubMed 25575788

  • 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.

    PubMed 17669950

  • 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.

    PubMed 31576402

  • 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.

    PubMed 16476552

  • 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.

    PubMed 15209858

  • 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.

    PubMed 12705652

  • Ismail A, Semien G, Sharma S, Collier SA, Miskolczi SY. Cardiopulmonary Bypass. 2024 Aug 12. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482190/

    PubMed 29489210

  • 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

  • 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

  • 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.

    PubMed 24728884

Questions about this trial

What is this clinical trial studying?

A study testing Self-expanding Venous Cannula in people with Cardiac Surgery and Heart Surgery, run by Eurosets S.r.l. at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness: the mean pressure drop (mm Hg) to maintain the desired flow rate (L/min) during the standard surgical procedure (time frame: During the surgical procedure (Day 0)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07087639, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.

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