Total flow medical femoral arterial cannula evaluation during cardiopulmonary bypass
| ISRCTN | ISRCTN70955202 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70955202 |
- Submission date
- 17/10/2025
- Registration date
- 21/10/2025
- Last edited
- 21/10/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Femoral arterial cannulation is used as part of the heart-lung machine during heart surgery, but it can lead to reduced blood flow to the leg, resulting in potential complications. Current solutions to maintain limb perfusion are limited and can add procedural complexity. The Total Flow Medical Femoral Arterial Cannula is a novel device designed to provide sufficient blood flow to the entire body, including the leg. Preclinical testing has shown promising results supporting its safety and performance. This study will evaluate the device in a clinical setting.
Who can participate?
Adult patients undergoing elective minimally invasive heart surgery requiring femoral arterial cannulation.
What does the study involve?
Eligible adults undergoing elective minimally invasive cardiac surgery requiring femoral arterial cannulation will be enrolled after informed consent. The Total Flow Medical Femoral Arterial Cannula will be used according to its instructions for use, with procedural data, intraoperative hemodynamic and perfusion metrics being collected.
What are the possible benefits and risks of participating?
Participants may not directly benefit from taking part. Risks are similar to those of standard femoral cannulation and cardiopulmonary bypass, including bleeding, vascular injury, limb ischemia, or infection.
Where is the study run from?
Foothills Medical Centre in Calgary, AB, Canada.
When is the study starting and how long is it expected to run for?
June 2025 to March 2026. The study is anticipated to start enroling in October 2025 and finish by March 2026.
Who is funding the study?
Total Flow Medical Limited, Canada.
Who is the main contact?
Matt Rieger, PhD, ACRP-CP, matt.rieger@ucalgary.ca
Contact information
Scientific, Principal investigator
Libin Cardiovascular Institute, Foothills Medical Center
University of Calgary
3330 Hospital Drive NW
Calgary
T2N 4N1
Canada
| Phone | +1 403.944.5480 |
|---|---|
| william.kent@ahs.ca |
Public
University of Calgary
3330 Hospital Drive NW
Calgary
T2N 4N1
Canada
| Phone | +1 403.210.6157 |
|---|---|
| matt.rieger@ucalgary.ca |
Study information
| Study design | Single-arm non-randomized prospective |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Safety |
| Scientific title | Total flow medical femoral arterial cannula evaluation during cardiopulmonary bypass |
| Study acronym | TACTIC |
| Study objectives | To assess the technical performance and clinical use of the Total Flow Medical Femoral Arterial Cannula in subjects undergoing minimally invasive cardiac surgery on cardiopulmonary bypass. |
| Ethics approval(s) |
Submitted 25/07/2025, Co-joint Health Research Ethics Board (CHREB) (2500 University Drive N.W., Calgary, T2N 1N4, Canada; +1 (403) 220-2297; chreb@ucalgary.ca), ref: REB25-1197 |
| Health condition(s) or problem(s) studied | Femoral arterial cannulation during minimally invasive cardiac surgery |
| Intervention | Participants undergoing elective minimally invasive cardiac surgery requiring femoral arterial cannulation will be enrolled after written informed consent. During surgery, the Total Flow Medical Femoral Arterial Cannula will be used as an arterial delivery cannula according to the device’s instructions for use. Procedural data (line pressures, flow rate, mean arterial pressure and limb near-infrared spectroscopy [NIRS] perfusion values) will be collected intraoperatively. Post-operative monitoring will continue through discharge, with a single follow-up assessment at 30 days. Total duration of participation: approximately 30 days per subject (intraoperative through 30-day follow-up). Total study duration: expected enrollment and follow-up period of ~5 months. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Total flow medical femoral arterial cannula |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 01/06/2025 |
| Completion date | 30/03/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target number of participants | 10 |
| Key inclusion criteria | Patients undergoing elective minimally invasive cardiac surgery (MICS) with clinical indications for femoral cannulation for cardiopulmonary bypass. |
| Key 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) |
| Date of first enrolment | 27/10/2025 |
| Date of final enrolment | 10/02/2026 |
Locations
Countries of recruitment
- Canada
Study participating centre
3330 Hospital Drive NW
Calgary
T2N 4N1
Canada
Sponsor information
Industry
300, 1001 West Broadway
Vancouver
V6H 4B1
Canada
| Phone | +1 604 734 7275 |
|---|---|
| hpierce@totalflowmedical.com | |
| Website | https://www.totalflowmedical.com/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 30/03/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
20/10/2025: Study's existence confirmed by the Medical Devices Directorate, Health Canada, Canada.
