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Vsling III: Vsling™ III: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients With Heart Failure

Sponsor
Cardiac Success (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06002386
Collaborator
(none)
10
Enrollment
1
Arm
49
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Vsling
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Device Feasibility
Official Title:
Vsling™ III: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients With Heart Failure
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Oct 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Vsling device

Vsling device implantation

Device: Vsling
Implantable ventricular repair device

Outcome Measures

Primary Outcome Measures

  1. Device related Serious Adverse Events (SAE) [30 days]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Age≥ 18 and < 85 years

  2. Left ventricular end diastolic diameter is greater than or equal to 55mm

  3. Ejection fraction ≥20% and ≤40%

  4. FMR grade ≤ 2+ (≤ mild FMR) as defined by the guidelines of the American society of echocardiography (via a transthoracic or transesophageal echo)

  5. End-systolic Interpapillary muscle distance ≥ 20mm

  6. NYHA class II-IVa

  7. Cardiomyopathy of ischemic or non-ischemic origins

  8. Understands the nature of the study and procedure and able to provide written informed consent

Exclusion Criteria:

  1. Any evidence of structural (chordal or leaflet) mitral lesions

  2. Ventricular tachycardia or ventricular fibrillation within 6 months prior to inclusion in this study

  3. Prior mitral valve repair or replacement

  4. ICD/CRT/cardiac pacemaker leads implanted within 3 months prior to inclusion in this study

  5. Clinical signs of cardiogenic shock within 30 days prior to inclusion in this study

  6. Anatomy that, in the opinion of the interventionalist, prevents safe passage of the Vsling™ catheter(s).

  7. Severe aortic stenosis

  8. Severe, massive, or torrential tricuspid regurgitation requiring surgical or transcatheter repair

  9. Known fixed pulmonary hypertension with PA systolic pressure >70 mmHg not responsive to vasodilator therapy

  10. ST segment elevation myocardial infarction within 30 days prior to inclusion in this study

  11. Congenital heart disease (except PFO, PDA or ASD)

  12. Heart Failure due to confirmed amyloid or other restrictive cardiomyopathies

  13. Chronic renal insufficiency defined by Creatinine ≥ 3.0 mg/dL or chronic renal replacement therapy

  14. Any therapeutic invasive cardiac procedure within 30 days prior to inclusion in the study

  15. Any cardiac surgery, within 3 months prior to inclusion in the study

  16. Cerebrovascular Accident (CVA) within 90 days prior to inclusion in this study

  17. Thrombocytopenia (Platelet count< 100,000/mm3) or thrombocytosis (Platelet count > 750,000/mm3)

  18. Body temperature >38°C within 3 days prior to index procedure

  19. Bleeding disorders or hypercoagulable state

  20. Active peptic ulcer or active gastrointestinal (GI) bleeding within 90 days of the scheduled implant

  21. Contraindication to anticoagulants or antiplatelet agents

  22. Known allergy to stainless steel, nickel, titanium or contrast agents that cannot be adequately pre-medicated

  23. Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically

  24. Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study

  25. Co-morbid condition(s) that, in the opinion of the Investigator, limit life expectancy to < 12 months

  26. Co-morbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study

  27. Pregnancy

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cardiac Success

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cardiac Success
ClinicalTrials.gov Identifier:
NCT06002386
Other Study ID Numbers:
  • CL-9022
First Posted:
Aug 21, 2023
Last Update Posted:
Aug 21, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Heart Failure

Study Results

No Results Posted as of Aug 21, 2023