Total flow medical femoral arterial cannula evaluation during cardiopulmonary bypass

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN70955202

Enrollment

Registered

2025-10-21

Start date

2025-10-27

Completion date

Unknown

Last updated

2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femoral arterial cannulation during minimally invasive cardiac surgery Surgery

Interventions

Participants undergoing elective minimally invasive cardiac surgery requiring femoral arterial cannulation will be enrolled after written informed consent. During surgery, the Total Flow Medical Femor

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients undergoing elective minimally invasive cardiac surgery (MICS) with clinical indications for femoral cannulation for cardiopulmonary bypass.

Exclusion criteria

Exclusion criteria: 1. Patients undergoing complex cardiac procedures beyond single-valve surgery, emergency surgery, or requiring non-femoral cannulation 2. Significant femoral artery disease or anatomy potentially unsuitable for the investigational cannula 3. High-risk clinical conditions (e.g., stroke, shock, infection, renal failure)

Design outcomes

Primary

Measure	Time frame
The technical performance of the Total Flow Medical femoral arterial cannula will be measured by incorporating observations made throughout the bypass period, using a structured procedural evaluation form completed by the surgical and perfusion team based on the device Instructions for Use (IFU); this includes assessment of handling characteristics (insertion, use, and withdrawal), clinician-determined adequacy of perfusion, and objective intraoperative parameters such as cannula flow rate (L/min), arterial line pressure (mmHg), mean arterial pressure (MAP), and limb near-infrared spectroscopy (NIRS) values, immediately after cardiopulmonary bypass	—

Measure

Time frame

The technical performance of the Total Flow Medical femoral arterial cannula will be measured by incorporating observations made throughout the bypass period, using a structured procedural evaluation form completed by the surgical and perfusion team based on the device Instructions for Use (IFU); this includes assessment of handling characteristics (insertion, use, and withdrawal), clinician-determined adequacy of perfusion, and objective intraoperative parameters such as cannula flow rate (L/min), arterial line pressure (mmHg), mean arterial pressure (MAP), and limb near-infrared spectroscopy (NIRS) values, immediately after cardiopulmonary bypass

—

Secondary

Measure	Time frame
Safety events are measured using data collected from operative reports, medical records, and electronic case report forms (eCRFs), including vascular injury, bleeding, limb ischemia, or other device- or procedure-related adverse events, at hospital discharge (=5 days) and at 30-day follow-up	—

Countries

Canada

Contacts

Public ContactMatt Rieger

matt.rieger@ucalgary.ca+1 403.210.6157

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026