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Hemodynamic and Clinical Monitoring Program During and After the MitraClip® Procedure in Patients with Secondary MR and Advanced Systolic Heart Failure

Hemodynamic and Clinical Monitoring Program During and After the MitraClip® Procedure in Patients with Secondary MR and Advanced Systolic Heart Failure - Mitraclip Conductance

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00011138
Enrollment
50
Registered
2016-11-30
Start date
2016-04-06
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 I34

Interventions

Group 1: during mitraclip procedure in Patient with severe mitral valve insufficiency and severe left ventricular dysfunction (Ef <25%) we used routinely a multimodal hemodynamic Monitoring Programm,

Sponsors

Universitätsklinikum Magdeburg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: -Age >18 years -Systolic heart failure, EF < 25%, NYHA III/IV -Severe functional mitral regurgitation according to ACC/AHA guidelines: ERO = 20 mm2, regurgitant fraction = 50%, regurgitant volume = 30ml -Clinical indication for MitraClip® Implantation -Cardiac index = 2.1 l/min/qm -Signed written informed consent

Exclusion criteria

Exclusion criteria: -Myocardial infarction within the last 3 months -Consuming tumor with an expected life expectancy < 12 months -Impossibility of MitraClip®-Implantation -Inability to follow instructions or comply with follow-up procedures, e.g. 6-minute-Walking Test -Pregnancy

Design outcomes

Primary

MeasureTime frame
This approach will help to find MR-dependent and independent predictors for the acute and chronic clinical and myocardial response (left ventricular remodelling) of Mitraclip® therapy in advanced systolic heart failure patients.

Countries

Germany

Contacts

Public ContactKerstin Schäfer

Universitätsklinikum Magdeburg, Klinik für Kardiologie

kerstin.schaefer@med.ovgu.de0391/6715190

Outcome results

None listed

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