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NCT07171060
Laplace Early Feasibility Study - Canada
Conditions: Tricuspid Regurgitation
Sex: All
Ages: 60 Years – 90 Years
Healthy volunteers: No
Phase: NA
Enrollment: 15
Sponsor: Laplace Interventional, Inc
Location: University of Ottawa Heart Institute Ottawa Ontario
Summary
The objective of the study is to assess the safety and technical feasibility of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System
Eligibility Criteria
Inclusion Criteria:
1. 60 - 90 years of age at the time of the study procedure
2. 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.
3. Severe, massive or torrential tricuspid regurgitation determined by qualifying transthoracic echocardiogram (TTE) and/or transesophageal echocardiogram (TEE) using the 5-grade classification.
4. 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.
5. Anatomically suitable for the Laplace TTVR system including trans-jugular access 6 Subject or legally authorized representative has provided informed consent and agrees to return for all required post-procedure follow-up visits
Exclusion Criteria:
1. Estimated life expectancy of less than 12 months
2. Systolic pulmonary artery pressure \> 65mmHg per TTE.
3. PVR \>5 Wood units
4. Acutely decompensated defined as hypotension with SBP \
Source: ClinicalTrials.gov (NCT07171060). StuddyBuddy aggregates publicly available trial information.