Compression Device to Reduce Pocket Hematoma After Cardiac Implantable Electronic Device Implantation in a High Bleeding Risk Population
Launched by MAXIME TIJSKENS · Dec 22, 2024
Trial Information
Current as of May 02, 2025
Completed
Keywords
ClinConnect Summary
Prospective study on the potential benefit of SafeGuard FocusTM compression dressing in preventing pocket bleeding after implantation of a cardiac implantable electrical device in patients with an increased risk of bleeding Introduction You are invited to participate in a research study involving up to 200 patients . The study aims to confirm the effectiveness and safety of the SafeGuard FocusTM compression bandage when compared to the conventional compression bandage. Your participation in the study will last a total of 1 month and will take place during the standard follow-up moments on t...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • patients undergoing primo CIED implantation (pacemaker, internal cardiac defibrillator or cardiac resynchronization therapy)
- • with a high bleeding risk (as defined by at least 1 of the following risk factors: age \> 75 years, heart failure, kidney failure, antithrombotic use (double antiaggregant therapy or anticoagulation
- Exclusion Criteria:
- • refusal to participate
- • mental illness
About Maxime Tijskens
Maxime Tijskens is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes. With a focus on innovative therapies and rigorous scientific methodologies, the organization collaborates with healthcare professionals, regulatory bodies, and research institutions to design and execute high-quality clinical trials. Maxime Tijskens prioritizes ethical standards, patient safety, and data integrity, ensuring that all studies contribute valuable insights to the medical community. Through a strategic approach and a passion for transformative healthcare solutions, Maxime Tijskens aims to address unmet medical needs and foster the development of groundbreaking treatments.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Wilrijk, Antwerp, Belgium
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported