Investigation of Predictive Factors for Hemodynamic Deterioration During Ventricular Arrhythmias in Patients with Left Ventricular Assist Devices

Investigation of Predictive Factors for Hemodynamic Deterioration During Ventricular Arrhythmias in Patients with Left Ventricular Assist Devices - LVAD-CF trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000056540

Enrollment

Registered

2024-12-25

Start date

2024-11-19

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Severe heart failure with LVAD

Interventions

In patients in whom sustained ventricular arrhythmia could not be induced during a standard electrophysiological study, pacing at 160 bpm and 200 bpm is performed for 5 minutes each.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients who underwent left ventricular assist device (LVAD) implantation between January 1, 2015, and March 31, 2027, and are currently on LVAD support. 2.Patients meeting any of the following conditions and scheduled for hemodynamic evaluation via right heart catheterization: 1).Patients undergoing routine follow-up examinations (e.g., immediately post-LVAD implantation or in preparation for heart transplantation). 2).Patients experiencing frequent activation of the low-flow alarm. 3).Patients with uncontrollable systemic congestion (e.g., pleural effusion, lower extremity edema). 4).Patients with worsening valvular disease (defined as an increase in severity by at least one grade). 3.Patients with structural heart disease, left ventricular ejection fraction <40%, and documented ventricular arrhythmias. 4.Patients aged 18 years or older at the time of consent. 5.Patients who fully understand the study protocol and provide informed consent.

Exclusion criteria

Exclusion criteria: 1.Patients with sustained ventricular arrhythmias. 2.Patients deemed unsuitable for the use of an EP catheter or a Swan-Ganz thermodilution catheter. 3.Patients judged by the investigator to be inappropriate as study subjects. 4.Patients who cannot provide informed consent.

Design outcomes

Primary

Measure	Time frame
Percent change from baseline in cardiac index (CI) during VA or RV pacing	—

Secondary

Measure	Time frame
Deterioration in Circulation (CI Change -10, -20, -30%) Right atrial pressure, pulmonary artery index, pulmonary vascular resistance, cardiac output, left ventricular ejection fraction, tricuspid annular systolic distance, Left ventricular end-diastolic diameter, left atrial diameter, and valvular disease severity, baseline BNP Percent change from baseline in mixed venous oxygen saturation (SvO2) during VA or RV pacing Percent change from baseline in mean arterial blood pressure (mAoP) during VA or RV pacing Percent change from baseline in LVAD flow during VA or RV pacing LVEDD, LAD, and valvular disease severity during ventricular arrhythmias or RV pacing	—

Measure

Time frame

Deterioration in Circulation (CI Change -10, -20, -30%) Right atrial pressure, pulmonary artery index, pulmonary vascular resistance, cardiac output, left ventricular ejection fraction, tricuspid annular systolic distance, Left ventricular end-diastolic diameter, left atrial diameter, and valvular disease severity, baseline BNP Percent change from baseline in mixed venous oxygen saturation (SvO2) during VA or RV pacing Percent change from baseline in mean arterial blood pressure (mAoP) during VA or RV pacing Percent change from baseline in LVAD flow during VA or RV pacing LVEDD, LAD, and valvular disease severity during ventricular arrhythmias or RV pacing

—

Countries

Japan

Contacts

Public ContactTsukasa Watanabe

Department of Cardiovascular medicine, Kyushu University Hospital Cardiovascular medicine

watanabe.tsukasa@junnai.org092-642-5371

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026