ProspeCtive study for autOmated annulaR and atrial suturing systems using RAM® and C1™ technology to assist in minimally invasive mitral valve replacement

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00035909

Enrollment

Registered

2025-04-23

Start date

2024-10-01

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

I34.0

Interventions

Group 1: Mitral valve surgery in patients with mitral valve pathologies using RAM® and C1™ technology. Group 2: Comparison with a histological cohort of patients who underwent mitral valve surgery wit

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with: mitral valve pathology and indication for replacement Life expectancy >1 year Patients willing and able to sign the informed consent

Exclusion criteria

Exclusion criteria: Emergency procedures Patient who did not sign the informed consent form and/ or refuse to participate Patients unable to read or understand the informed consent

Design outcomes

Primary

Measure	Time frame
Procedural times: -Skin-to-skin -Opening of the left atrium until end of closure of the left atrium -Extracorporal circulation time -Aortic cross clamp time -Prosthesis implantation time (i.e., from start of first suture placement to placement of last annular knot) Functional assessment: -Postoperative hemodynamic performance (Echocardiographic measurement of trans prosthetic gradients and paravalvular leackage) at discharge and 3-6 months post-op.	—

Measure

Time frame

Procedural times: -Skin-to-skin -Opening of the left atrium until end of closure of the left atrium -Extracorporal circulation time -Aortic cross clamp time -Prosthesis implantation time (i.e., from start of first suture placement to placement of last annular knot) Functional assessment: -Postoperative hemodynamic performance (Echocardiographic measurement of trans prosthetic gradients and paravalvular leackage) at discharge and 3-6 months post-op.

—

Secondary

Measure	Time frame
Mortality 30 days -Morbidity (AEs, SAEs) 30 days	—

Countries

Germany

Contacts

Public ContactFarhad Bakhtiary

Klinik und Poliklinik für Herzchirurgie

farhad.bakhtiary@ukbonn.de+49228287-14190

Outcome results

None listed

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