RECRUITING

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

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.

Conditions

Heart Failure
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Related Conditions:

Heart Failure

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Heart Failure
Intervention / Treatment

-

Contacts and Locations

Boston

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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.
  • 27. Inadequate vascular access for implantation of V-LAPIM or are unable to tolerate a right heart catheterization (RHC).
  • 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.
  • 29. Resting systolic Blood Pressure \<90 or \>180 mmHg, not corrected with IV fluid administration or vasodilators.

Ages Eligible for Study

22 Years to 88 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

2028-04