Skip to content

Clinical course and prognostic significance of mitral valve insufficiency under LVAD (left ventricular assist device) therapy

Clinical course and prognostic significance of mitral valve insufficiency under LVAD (left ventricular assist device) therapy - none available

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00021594
Enrollment
60
Registered
2020-07-17
Start date
2020-05-18
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

I50.14 I34.0

Interventions

Group 1: Patients who had no or only mild MI (mitral regurgitation) at the time of LVAD implantation. Only those patients in our clinic who are currently supported by the LVAD system and who meet the

Sponsors

Klinik für Herzchirurgie, Rhön-Klinikum, Campus Bad Neustadt
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with an implanted LVAD system (left ventricular support system) and consent form for performing dynamic stress echocardiography and spiroergometry.

Exclusion criteria

Exclusion criteria: • Significant reduction in performance / deterioration of the general condition compared to the last follow-up examination (climbing stairs from a floor at a moderate pace is no longer possible without a break) • manifest cardiac decompensation (peripheral edema with weight gain of> 2 kg in the last 1 to 3 days, shortness of breath, persistent tachycardia / tachyarrhythmia with resting frequency> 100 beats / min, deterioration of the kidney / liver parameters with derailment derailment with equally dosed oral anticoagulation) • ICD triggering (anti-tachycardia pacing or shock delivery) • LVAD flow <3l / min, frequent suction events, technical alarms Significant Hb drop, Hb value <10 g / dl (mostly seen after gastrointestinal bleeding, rarely after spontaneous retroperitoneal bleeding with coagulation derailment) • serious thromboembolic / bleeding complications in the past 3 months (ischemic or hemorrhagic apoplex with persistent neurological deficits)

Design outcomes

Primary

MeasureTime frame
Mitral valve insufficiency at the time of the follow-up examination determined by 2 examination methods: dynamic stress echocardiography for quantification of a hypothesized MI that emerged or increased under load (latent post-LVAD MI), and spiroergometry for determination of the maximum oxygen intake per kg / kg / minute (SvO2) for estimation resilience (cardio-pulmonary reserve).

Secondary

MeasureTime frame
Survival under LVAD support, frequency of inpatient admission, TAPSE (tricuspid annular plane systolic excursion) as an echo parameter for assessing right ventricular pump function, creatinine and glomerular filtration rate (GFR) as a parameter for the progression of chronic renal failure (cNI).

Countries

Germany

Contacts

Public ContactAtanas Jankulovski

Klinik für Herzchirurgie, Rhön-Klinikum, Campus Bad Neustadt

Atanas.Jankulovski@campus-nes.de09771/6625433

Outcome results

None listed

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