The SPOT C-MIC Follow-up Study

The SPOT C-MIC Follow-up Study - SPOT FU

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00027419

Enrollment

Registered

2021-12-22

Start date

2021-12-23

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I50.9

Interventions

Group 1: Patients who already have the CMIC system implanted

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients from the per protocol treatment group who have received a C-MIC System during the SPOT C-MIC Study. Informed consent in writing from the patient

Exclusion criteria

Exclusion criteria: Patients who are unwilling or unable to participate in the study visits.

Design outcomes

Primary

Measure	Time frame
The primary objective to assess the safety of the C-MIC System in case of: • C-MIC System extended use or • C-MIC System abandonment or • C-MIC System explantation in patients having received a C-MIC System in the context of a prior study.	—

Secondary

Measure	Time frame
The secondary objective of this study is to assess the duration of improvement in cardiac performance reached through therapy with the C-MIC System regarding: • Performance outcomes • Clinician-reported outcome • Patient related outcome	—

Countries

Serbia

Contacts

Public ContactMiodrag Peric

Institute of Cardiovascular Diseases Dedinje

dedinje@ikvbd.com+381 (0) 11 3601 700

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026