DUO System for Tricuspid Regurgitation
(TANDEM II Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the DUO System, a new treatment for people with severe tricuspid regurgitation—a condition where the heart's tricuspid valve doesn't close properly, causing blood to flow backward. The study will evaluate the device's effectiveness and safety for patients who continue to experience symptoms despite medical treatment. Ideal participants have noticeable symptoms of tricuspid regurgitation and have been advised by a medical team that a valve procedure might be suitable. As an unphased trial, this study offers patients the chance to contribute to groundbreaking research that could lead to new treatment options.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team to get a clear answer.
What prior data suggests that the DUO Transcatheter Tricuspid Coaptation Valve System is safe?
Research has shown that the DUO Transcatheter Tricuspid Coaptation Valve System, or DUO System, has undergone testing in a few studies. In one study, the system was safely placed in a patient with tricuspid regurgitation, a heart valve issue. The procedure was minimally invasive, involving small cuts, which often leads to quicker recovery and fewer complications.
However, more information is needed to fully confirm its safety. Current evidence comes from early studies, so researchers are still testing it mainly for safety and effectiveness. Ongoing research aims to gather more details about patient tolerance and any possible side effects.12345Why are researchers excited about this trial?
The DUO Transcatheter Tricuspid Coaptation Valve System (DUO System) is unique because it offers a minimally invasive approach to treating tricuspid regurgitation, a condition where the heart's tricuspid valve fails to close properly, causing blood to flow backward. Unlike traditional open-heart surgery, which is the standard treatment, the DUO System is delivered through a catheter, potentially reducing recovery time and risks associated with major surgery. Researchers are excited because this approach can provide an option for patients who are not candidates for surgery, offering a promising alternative with fewer complications and quicker recovery.
What evidence suggests that the DUO System is effective for tricuspid valve treatment?
Research has shown that the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System), which participants in this trial will receive, can effectively reduce tricuspid regurgitation (TR). TR occurs when the heart's tricuspid valve doesn't close properly. In one study, patients experienced significant improvements in their quality of life, with these positive results lasting for at least six months. Early findings also indicated that the DUO System reduced TR without causing serious side effects. This suggests that the DUO System could be a promising option for people with this heart condition.46789
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the DUO Transcatheter Tricuspid Coaptation Valve System
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- DUO Transcatheter Tricuspid Coaptation Valve System
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Treatment with the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System)
Find a Clinic Near You
Who Is Running the Clinical Trial?
CroiValve Limited
Lead Sponsor
Citations
EFS of the DUO System for Tricuspid Regurgitation
Data collected in this clinical study will include safety and function of the investigational system as well as up to 5 year clinical outcomes. Official Title.
First Case of the Treatment of Massive Tricuspid ...
The efficacy and clinical improvement have been stable over the past 90 days of follow-up, and the patient has not suffered any adverse events. Conclusions.
Positive Six-Month Results from CroíValve's TANDEM I ...
“We are encouraged by these data, which demonstrate the DUO's success in reducing TR and improving patients' Quality of Life,” said Dr Martin ...
4.
nm.org
nm.org/conditions-and-care-areas/treatments/transcatheter-heart-valve-therapies-for-tricuspid-valveTranscatheter Heart Valve Therapies for the Tricuspid Valve
TANDEM : The purpose of this early feasibility study is to evaluate the safety and function of the DUO Transcatheter Tricuspid Coaptation Valve System (DUO ...
CroíValve Duo Evaluated for TR in 6-Month Results of ...
The TANDEM I first-in-human clinical trial of the company's Duo system for percutaneous treatment of tricuspid regurgitation (TR) showed sustained positive ...
A Feasibility Study of the CroíValve DUO System for ...
This study is prospective, multicentre, non-randomized single-arm early feasibility study to evaluate the safety and performance of the CroíValve DUO ...
First Case of the Treatment of Massive Tricuspid Regurgitation ...
This is the first implantation of the DUO Transcatheter Tricuspid Coaptation Valve System in a patient with lead-induced TR. The implant was safe and ...
8.
clinicaltrial.be
clinicaltrial.be/en/details/82116?only_active=0&only_eligible=0&only_recruiting=0&per_page=100A Feasibility Study of the CroíValve DUO System for Tricu...
This study is prospective, multicentre, non-randomized single-arm early feasibility study to evaluate the safety and performance of the ...
9.
revespcardiol.org
revespcardiol.org/en-orthotopic-transcatheter-tricuspid-coapt-articulo-S1885585723002694Orthotopic transcatheter tricuspid coaptation valve system ...
This is an isolated case and further data are needed to confirm its safety and efficacy in the long-term. The ongoing TANDEM I study (Identifier ...
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