Trisol System EFS Study
ConditionTricuspid Regurgitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTrisol Medical
About this trial
The objective of this early feasibility study is to gain early clinical insight into Trisol system safety and performance to treat patients with moderate or greater tricuspid regurgitation (TR).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >18 years.
Subject meets the legal minimum age to provide informed consent based on local regulatory requirements.
Participant has symptomatic, moderate or greater functional or degenerative tricuspid regurgitation (TR) as determined by the Echocardiography Core Lab assessment of a qualifying transthoracic echocardiogram (TTE) and/or transesophageal echocardiogram (TEE).
New York Heart Association (NYHA) Functional Class II to IVa.
Disqualifiers
Previous tricuspid valve repair or replacement which may impede proper study device delivery or deployment.
Stroke or transient ischemic event within the previous 90 days.
Acute myocardial infarction within the previous 90 days.
Hemodynamic instability requiring inotropic therapy or mechanical hemodynamic support devices.
Trial design
Design model
Single group
Treatments tested in this trial
Transcatheter Tricuspid Valve Replacement
DeviceReplacement of the tricusupid valve using Trisol System in a transcatheter approach
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Treatment with the Trisol SystemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rate of device-related serious adverse events
Rate of device-related serious adverse events, including death (cardiovascular and non- cardiovascular), MI (MVARC definitions), disabling stroke, life-threatening bleeding (MVARC type III-V), renal failure requiring dialysis, emergency surgery, need for additional surgical procedures due to device failure
Time frame
Up to 30 days2
Rate of technical success
Technical success: delivery and deployment of the device in the correct position and retrieval of the delivery system.
Time frame
During procedure3
Rate of procedural success
Procedural success: freedom from emergency surgery or reintervention related to the device or access procedure, without death, stroke, or device dysfunction
Time frame
Up to 30 days4
Change in TR from baseline
Change in TR from baseline: reduction in TR grade immediately following implantation as compared to baseline TR grade, based on TEE imaging.
Time frame
During procedureSecondary outcomes
1
Clinical performance endpoints - Change in TR from baseline
Change in TR from baseline: reduction in TR grade as compared to baseline TR grade, based on TTE imaging
Time frame
At 30 days, 6 months, 12 months2
Clinical performance endpoints - Change in NYHA class
New York Heart Association (NYHA) functional class: change in NYHA from baseline
Time frame
At 30 days, 6 months, 12 months, and then annually3
Clinical performance endpoints --minute walk test
Six-minute walk test: change in distance (m) from baseline
Time frame
At 30 days, 6 months and 12 months4
Quality-of-Life: change from baseline as measured by Kansas City Cardiomyopathy Questionnaire
Clinical performance endpoints -Quality-of-Life: change from baseline as measured by Kansas City Cardiomyopathy Questionnaire
Time frame
At 30 days, 6 months and 12 monthsSponsors and contacts
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Source ClinicalTrials.gov