Laplace Early Feasibility Study - Canada
ConditionTricuspid Regurgitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-90
SponsorLaplace Interventional, Inc
About this trial
The objective of the study is to assess the safety and technical feasibility of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System
Eligibility criteria
Qualifiers
60 - 90 years of age at the time of the study procedure
Symptomatic tricuspid regurgitation despite being adequately treated with optimal medical therapy by the Local Heart Team for at least 30 days prior to the time of study consent.
Severe, massive or torrential tricuspid regurgitation determined by qualifying transthoracic echocardiogram (TTE) and/or transesophageal echocardiogram (TEE) using the 5-grade classification.
Candidate felt suitable for transcatheter tricuspid valve replacement as determined by the local heart team and confirmed by the patient selection committee. For patients with pre-existing trans-tricuspid pacemaker or ICD leads, the local heart team shall include an electrophysiologist.
Disqualifiers
Estimated life expectancy of less than 12 months
Systolic pulmonary artery pressure > 65mmHg per TTE.
PVR >5 Wood units
Acutely decompensated defined as hypotension with SBP <90 mmHg, use of hemodynamic support devices or inotropes within the last 30 days
Trial design
Treatments tested in this trial
- Laplace TTVR System
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov