Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03966313
Other study ID # 7287
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 21, 2019
Est. completion date June 21, 2022

Study information

Verified date April 2020
Source University Hospital, Strasbourg, France
Contact Charles TACQUARD
Phone 0369551608
Email charlesambroise.tacquard@chru-strasbourg.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Implanting a ventricular assist device (VAD) is a promising therapy for end-stage cardiac failure. However, the implantation of these devices is associated with a high risk of severe hemorrhages and massive blood product transfusion in the first 48 hours following the implantation. The primary purpose of this study is to assess the functionality of the von Willebrand Factor (vWF) which is essential for hemostasis. The hypothesis is that the high shear stress generated by these VAD expose ADAMTS13 cleaving site on the vWF. This result in a loss of high molecular weight vWF and an acquired von Willebrand syndrome.

The secondary purpose of the protocol is to assess platelet function after the implantation of VAD. Indeed, platelet function might be affected shortly after the implantation of the device.


Recruitment information / eligibility

Status Recruiting
Enrollment 45
Est. completion date June 21, 2022
Est. primary completion date June 21, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age over 18 years old

- Who gave his consent to the study

- With an end-stage heart-failure

- Under surgery for a ventricular assist device implantation

- Scheduled or in emergency

Exclusion Criteria:

- Preoperative anemia less than 7 g/dL

- Subject under the protection of justice

- Subject under guardianship or curatorship

- Pregnancy

- Breastfeeding

Study Design


Related Conditions & MeSH terms


Intervention

Device:
ventricular assist device implantation
Blood sampling in patients under surgery for ventricular assist device implantation at five time points: After anesthetic induction Before starting the device 2h, 6h and 48h after starting the device

Locations

Country Name City State
France Hopitaux Universitaire de Strasbourg Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Von Willebrand Factor activity Change of Von Willebrand Factor from Baseline to 48 hours From Baseline to 48 hours
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06063811 - Ventricular Tachycardia Ablation in LVAD Patients
Withdrawn NCT04782245 - Acute Reno-Cardiac Action of Dapagliflozin In Advanced Heart Failure Patients on Heart Transplant Waiting List Phase 2
Active, not recruiting NCT04351945 - Endocrine Changes and Their Correction in Heart and Lung Transplant Recipients and Donors
Recruiting NCT02592499 - Swedish Evaluation of Left Ventricular Assist Device as Permanent Treatment in End-stage Heart Failure N/A
Active, not recruiting NCT00483197 - VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Pivotal Trial Phase 3
Active, not recruiting NCT00490321 - VentrAssistTM LVAD for the Treatment of Advanced Heart Failure - Destination Therapy Phase 3
Completed NCT04543747 - Mechanical Circulatory Support Korea Post Market Surveillance Study (PMS)
Recruiting NCT04293575 - Transcatheter Mitral Valve Repair as Bridge Therapy to Heart Transplantation
Recruiting NCT04641416 - Noninvasive Cardiovascular Diagnosis of Patients With Fully Magnetically Levitated Blood Pumps
Completed NCT00490347 - VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Feasibility Trial Phase 2
Suspended NCT04117295 - Carmat TAH Early Feasibility Study N/A
Completed NCT05353816 - Corheart 6 Left Ventricular Assist System Prospective, Multicenter, Single-arm Clinical Evaluation Trial N/A
Completed NCT04480151 - ECLS Versus IMPELLA™ as Bridge to LVAD (ECI-BLAD)
Recruiting NCT04205760 - Preoperative Nutritional Optimization and Physical Exercise for Patients Scheduled for Elective Implantation for a Left-Ventricular Assist Device Phase 3
Recruiting NCT06345521 - Etablishment of Follow-up System and End-Stage Heart Registration Platform for Pediatric Heart Failure
Recruiting NCT04768322 - LVAD Versus GDMT in Ambulatory Advanced Heart Failure Patients N/A
Completed NCT02248974 - Development & Testing of a Decision Aid for LVAD Placement N/A
Completed NCT06152562 - Evaluation of Platelet Therapy Response in Left Ventricular Assist Device Patients
Completed NCT05928273 - Corheart 6 LVAS LTFU N/A
Recruiting NCT04951999 - AssocIation of PULSatility and Occurrence of Complications Related to Mechanically Assisted Circulatory Support N/A