RegiVe: 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

Sponsor

Berlin Heart GmbH (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04782232

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Univentricular Heart Ventricular Dysfunction Heart Diseases Cardiovascular Diseases	Other: No intervention

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Nov 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Patients with failing/absence of the right heart 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.	Other: No intervention No intervention due to observational design

Arm

Intervention/Treatment

Patients with failing/absence of the right heart

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.

Other: No intervention

No intervention due to observational design

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Rate of adverse events [up to 12 months]
Safety of the device

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.