Vsling™ I: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients With Heart Failure
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
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
Qualifiers
Age≥18 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
Treatments tested in this trial
- Vsling
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov