Examining the link between pulsatility and complications in heart failure patients with LVADs
AssocIation of PULSatility and Occurrence of Complications Related to Mechanically Assisted Circulatory Support
This study is testing if keeping a normal blood flow pattern in heart failure patients with LVADs can help reduce bleeding problems related to a blood clotting factor.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT04951999 on ClinicalTrials.gov |
What this trial studies
This study investigates whether maintaining pulsatility in patients with continuous flow Left Ventricular Assist Devices (CF-LVAD) is linked to a reduced deficiency of Von Willebrand factor, which is crucial for blood clotting. The research involves measuring blood pressure differentials at various stages post-implantation to assess pulsatility. The primary goal is to determine if preserved pulsatility correlates with fewer bleeding complications due to Von Willebrand factor deficiency. Participants will be monitored for up to six months after their LVAD implantation.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 who are undergoing implantation of a left-sided monoventricular assist device for end-stage heart failure.
Not a fit: Patients who have previously received an LVAD, are heart transplant recipients, or have chronic renal failure on dialysis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of bleeding risks in heart failure patients receiving LVADs.
How similar studies have performed: While the relationship between pulsatility and complications in LVAD patients has been suggested in literature, this specific approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients over 18 years of age 2. Patients for whom a decision to implant a left-sided monoventricular assist has been retained after discussion in the RCP of heart failure, transplantation and circulatory assistance (whatever the therapeutic strategy envisaged: waiting for transplantation, recovery or destination therapy). 3. Patients affiliated to a social security system (beneficiaries or beneficiaries entitled to benefits, excluding AME) 4. Signature of an informed consent by the patient or by the trusted person, or a close relative, if the patient is not able to do so Exclusion Criteria: 1. Heart transplant patients 2. Patients who already had LVAD 3. Chronic renal failure patients on dialysis 4. Patients refusing to give informed consent 5. Patients deprived of liberty or under legal protection (guardianship, curators) 6. Pregnant or breastfeeding women 7. Ongoing participation in another intervention research protocol except LEVOECMO project (NCT04728932) and ANCHOR project (NCT04184635)
Where this trial is running
Paris
- Groupement Hospitalier pitié Salpêtrière — Paris, France (Recruiting)
Study contacts
- Principal investigator: Guillaume LEBRETON, MD, PhD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Guillaume LEBRETON, MD, PhD
- Email: guillaume.lebreton@aphp.fr
- Phone: +33142162979
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.