RECRUITING

A Multi-center, National, Open-label, Prospective Study to Evaluate the Performance of the V-Lap™ System

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Conditions

Heart Failure

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The objective of this study is to evaluate the safety and performance of the V-LAP System in subjects with New York Heart Association (NYHA) functional class II and III HF, irrespective of left ventricular ejection fraction.

Official Title

A Multi-center, National, Open Label, Prospective Study to Evaluate the Safety, Usability and Performance of the V-LAP™ System, for Wirelessly Measuring and Monitoring Left Atrial Pressure (Lap) in Patients With Advanced CHF

Quick Facts

Study Start:2024-06-11
Study Completion:2028-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06147336

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 88 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 26. Anatomical anomaly on TEE or ICE that precludes implantation of the V-LAPIM across the interatrial septum (Fossa Ovalis) including: Septal thickness at fossa \> 5 mm, FO Dimension \<16mm, ASD or PFO with more than a trace amount of shunting, intra-cardiac thrombus felt to be acute and not present on prior exams and abnormal septum, e.g., a hypermobile septum or a septal aneurysm.
  2. 27. Inadequate vascular access for implantation of V-LAPIM or are unable to tolerate a right heart catheterization (RHC).
  3. 28. Severe pulmonary hypertension at index procedure above 70 mmHg or PVR at index procedure above 4.0 Woods Units (mmHg L-1 min-1), while these cannot be lowered with vasodilators.
  4. 29. Resting systolic Blood Pressure \<90 or \>180 mmHg, not corrected with IV fluid administration or vasodilators.

Contacts and Locations

Study Contact

Dedi Erdheim, Mr.
CONTACT
+972 72 342 5462
dedi@vectoriousmedtech.com

Principal Investigator

Rami Kahwash, Prof.
PRINCIPAL_INVESTIGATOR
Ohio State University
Ramesh Emani, Dr.
PRINCIPAL_INVESTIGATOR
Christ Hospital - Linder Research Institute
Sandip Zalawadiya, Dr.
PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Nir Ayalon, Dr.
PRINCIPAL_INVESTIGATOR
Boston Medical Center
Michael DiVita, Dr.
PRINCIPAL_INVESTIGATOR
NYU Langone

Study Locations (Sites)

One Boston Medical Center Place
Boston, Massachusetts, 02118
United States

Collaborators and Investigators

Sponsor: Vectorious Medical Technologies Ltd.

  • Rami Kahwash, Prof., PRINCIPAL_INVESTIGATOR, Ohio State University
  • Ramesh Emani, Dr., PRINCIPAL_INVESTIGATOR, Christ Hospital - Linder Research Institute
  • Sandip Zalawadiya, Dr., PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center
  • Nir Ayalon, Dr., PRINCIPAL_INVESTIGATOR, Boston Medical Center
  • Michael DiVita, Dr., PRINCIPAL_INVESTIGATOR, NYU Langone

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-11
Study Completion Date2028-04

Study Record Updates

Study Start Date2024-06-11
Study Completion Date2028-04

Terms related to this study

Additional Relevant MeSH Terms

  • Heart Failure