Laplace Outside the US (OUS) Early Feasibility Study (EFS) Canada

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The objective of the study is to assess the safety and technical feasibility of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 90
Healthy Volunteers: f
View:

• 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.

• 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

Locations
Other Locations
Canada
Sunnybrook Research Institute
RECRUITING
Toronto
Contact Information
Primary
Ryan Gladney
clinical@laplaceint.com
763-710-3539
Time Frame
Start Date: 2024-06-18
Estimated Completion Date: 2031-01-01
Participants
Target number of participants: 15
Treatments
Experimental: Tricuspid Valve Replacement
Transcatheter Tricuspid Valve Replacement (TTVR) System for the treatment of severe, symptomatic tricuspid regurgitation
Related Therapeutic Areas
Sponsors
Leads: Laplace Interventional, Inc

This content was sourced from clinicaltrials.gov