Vsling™ III: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients with Heart Failure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorCardiac Success
About this trial
Prospective, multi-center, open-label clinical study of the feasibility and initial safety and performance of the Vsling™ in patients with heart failure (HF) with evidence of reduced left ventricular ejection fraction, associated with ventricular dilation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age≥ 18 and < 85 years
Left ventricular end diastolic diameter is greater than or equal to 55mm
Ejection fraction ≥20% and ≤40%
FMR grade ≤ 2+ (≤ mild FMR) as defined by the guidelines of the American society of echocardiography (via a transthoracic or transesophageal echo)
Disqualifiers
Any evidence of structural (chordal or leaflet) mitral lesions
Ventricular tachycardia or ventricular fibrillation within 6 months prior to inclusion in this study
Prior mitral valve repair or replacement
ICD/CRT/cardiac pacemaker leads implanted within 3 months prior to inclusion in this study
Trial design
Design model
Single group
Treatments tested in this trial
Vsling
DeviceImplantable ventricular repair device
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Vsling deviceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Device related Serious Adverse Events (SAE)
Device related Serious Adverse Events (SAE) within 30 days of the procedure: any SAE that has been determined by the safety monitor to be related to the Vsling™ implantation procedure or the Vsling™ device
Time frame
30 daysLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: