NCT04782232

Registry to Assess the Safety and Feasibility of the Subpulmonary Support with the Novel Venous Cannula in Patients with Failing/Absence of the Right Heart

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Berlin Heart GmbH · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to monitor the clinical safety and performance of the EXCOR Venous Cannula in context of an EXCOR VAD therapy to ensure continued acceptability of identified risks, to enable detecting emerging risks and to assess clinical improvement on both short- and long-term.

Detailed description

The registry study has an observational, prospective, international, multi-center, non-randomized design. The registry is planned for 42 months (3.5 years), with an enrollment period of 28 months, the follow-up of up to 12 months.

Conditions

• Heart Failure
• Univentricular Heart
• Ventricular Dysfunction
• Heart Diseases
• Cardiovascular Diseases

Interventions

Type	Name	Description
OTHER	No intervention	No intervention due to observational design

Timeline

• Start date: 2021-06-01
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2021-03-04
• Last updated: 2025-02-17

Locations

1 site across 1 country: Germany