Laplace Early Feasibility Study - Canada
The objective of the study is to assess the safety and technical feasibility of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System
| Condition(s) | Tricuspid Regurgitation |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The objective of the study is to assess the safety and technical feasibility of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System |
| Who can participate | 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 |
| Ages | 60 Years to 90 Years |
| Sex | All |
| Lead sponsor | Laplace Interventional, Inc |
| Locations | Toronto, Ontario, Canada |
| Start date | 2024-06-18 |
| NCT ID | NCT07171060 |
| Official listing | https://clinicaltrials.gov/study/NCT07171060 |