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

Recruiting

• Conditions: Heart Failure; Univentricular Heart; Ventricular Dysfunction; Cardiovascular Diseases; Heart Diseases
• Interventions: Other: No intervention

• Registration Number: NCT04782232
• Lead Sponsor: Berlin Heart GmbH

Brief 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.

Study Timeline

• Study First Submitted: 2021-02-15
• Study First Submitted QC: 2021-03-03
• Study First Posted: 2021-03-04
• Study Start: 2021-06-01
• Status Verified: 2024-08
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-17
• Primary Completion: 2027-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patient or his/her parent/guardian or legally authorized representative has given the consent by means of a written, signed and dated informed consent form,
• The indications on RVAD and BVAD use of the EXCOR VAD apply,
• Patient shall be on transplant list or at least eligible for HTx,
• BSA (body surface area) greater than or equal to 1.2 m².

Exclusion Criteria

• Patient or his/her parents/legal guardian or legally authorized guardian has not given the consent,
• The contraindications of EXCOR VAD apply.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with failing/absence of the right heart	No intervention	Patients with acute or chronic, conservatively uncontrollable heart failure of varying pathogenesis, graded as stage III or IV according to NYHA, with an anticipated need for short-term to long-term right ventricular or biventricular support.

Primary Outcome Measures

Name	Time	Method
Rate of mortality	30 days	Short-term mortality
Survival to heart transplantation	up to 12 months	Long-term survival to heart transplantation
Rate of major bleeding	30 days	Short-term rate of major bleeding
Rate of thrombosis	30 days	Short-term rate of thrombosis

Secondary Outcome Measures

Name	Time	Method
Rate of adverse events	up to 12 months	Safety of the device

Trial Locations

Locations (1)

LMU Klinikum; 🇩🇪 Munich, Germany