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New treatment option for Tricuspid Regurgitation
Official title Laplace Early Feasibility Study - Canada
ClinicalTrials.gov ID: NCT07171060
What this study is testing
- What it's testing
- The objective of the study is to assess the safety and technical feasibility of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 to 90
You may be able to join if
- 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...
- Severe, massive or torrential tricuspid regurgitation determined by qualifying transthoracic echocardiogram (TTE) and/or transesophageal...
- Candidate felt suitable for transcatheter tricuspid valve replacement as determined by the local heart team and confirmed by the patient selection...
- Anatomically suitable for the Laplace TTVR system including trans-jugular access 6 Subject or legally authorized representative has provided informed...
You likely can't join if
- 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
- Severe COPD dependent on home oxygen or chronic home oxygen use
- Echocardiographic evidence of severe right ventricular dysfunction
See the full eligibility criteria
- 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...
- 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...
- 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
- Severe COPD dependent on home oxygen or chronic home oxygen use
- Echocardiographic evidence of severe right ventricular dysfunction
- Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation requiring treatment
- New or untreated right heart chamber or/and superior vena cava intracardiac mass, thrombus, or vegetation
- Presence of significant congenital heart disease including but not limited to hemodynamically significant atrial septal defect, RV dysplasia, and arrhythmogenic RV.
- Untreatable hypersensitivity or contraindication to any of the following: Aspirin, and Clopidogrel or Ticlopidine, Heparin, and Bivalirudin, Warfarin, or DOAC, Nitinol Alloys. Severe renal insufficiency defined as eGFR...
- Transfusion dependent chronic anemia with Hb \<9/dL
- Current or planned pregnancy within next 12 months for women of childbearing potential
- Active or recent endocarditis within last 90 days or, sepsis/ other systemic infection requiring oral or intravenous antibiotics within last 30 days
- Prior tricuspid repair or tricuspid replacement or other device that would interfere with successful deployment or functioning of Laplace tricuspid valve.
- Participation in another pre-market investigational device study or investigational drug study for a cardiac related drug
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical...
- Left ventricular ejection fraction (LVEF) \< 30%
- Deep vein thrombosis or pulmonary embolism within last 6 months
- Child-Pugh C cirrhosis.
- Contraindication or inability to complete TEE
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.