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New treatment option for Tricuspid Regurgitation Functional
Official title Early Feasibility Study of the Cardiac Implants Percutaneous Ring Annuloplasty System
ClinicalTrials.gov ID: NCT04890821
What this study is testing
- What it's testing
- An early feasibility study to evaluate the safety and performance of 1) the transcatheter delivery and implantation of the Cardiac Implants (CI) annuloplasty ring and 2) the adjustment of the ring approximately 90 days following implantation in patients suffering from ≥ moderate functional tricuspid regurgitation (FTR).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Moderate to severe functional tricuspid regurgitation (TR) defined by ASE guidelines and the European Association of Echocardiography guidelines.
- Tricuspid valve annular diameter ≥ 40mm or \> 21 mm/m2 as measured by baseline TTE in a 4-chamber view within 90 days prior to index implant...
- Age ≥ 18 years old at the time of enrollment.
- New York Heart Associate Classification ≥ II.
- Symptoms of right heart failure despite optimized medical therapy.
You likely can't join if
- Acute decompensated heart failure requiring hospital admission with 4 weeks of enrollment.
- Severe RV dysfunction as assessed by echocardiography.
- Primary (organic) tricuspid pathology (e.g. rheumatic, congenital, infective, etc.).
- Currently participating in another investigational drug or device study.
- Systolic pulmonary arterial pressure (sPAP) \> 70 mmHg as measured by Transthoracic Echocardiography (TTE).
- Subject requiring another cardiac procedure in the framework of the index procedure; subject requiring a percutaneous procedure within 30 days before...
See the full eligibility criteria
- Moderate to severe functional tricuspid regurgitation (TR) defined by ASE guidelines and the European Association of Echocardiography guidelines.
- Tricuspid valve annular diameter ≥ 40mm or \> 21 mm/m2 as measured by baseline TTE in a 4-chamber view within 90 days prior to index implant procedure.
- Age ≥ 18 years old at the time of enrollment.
- New York Heart Associate Classification ≥ II.
- Symptoms of right heart failure despite optimized medical therapy.
- Multidisciplinary heart team (minimum of four physicians, including imaging, Structural Heart Disease Interventionalist, Heart Failure Cardiologist, and Cardiac Surgeon) agree that percutaneous tricuspid annuloplasty is...
- Left Ventricular Ejection Fraction (LVEF) ≥ 30% within 90 days prior to index implant procedure
- The subject has suitable anatomy for investigational device implantation as per imaging requirements.
- The subject has read and signed the informed consent prior to study related procedures.
- The subject is willing and able to comply with all required follow-up evaluations and assessments.
- Acute decompensated heart failure requiring hospital admission with 4 weeks of enrollment.
- Severe RV dysfunction as assessed by echocardiography.
- Primary (organic) tricuspid pathology (e.g. rheumatic, congenital, infective, etc.).
- Currently participating in another investigational drug or device study.
- Systolic pulmonary arterial pressure (sPAP) \> 70 mmHg as measured by Transthoracic Echocardiography (TTE).
- Subject requiring another cardiac procedure in the framework of the index procedure; subject requiring a percutaneous procedure within 30 days before or after the procedure or a cardiac surgical procedure within 3...
- Tricuspid valve stenosis.
- Aortic, mitral and/or pulmonic valve stenosis and/or regurgitation more than moderate.
- Intra-cardiac thrombus, mass or vegetation requiring active treatment.
- Prior tricuspid repair or tricuspid replacement.
- Known allergy to contrast media, stainless steel or nitinol that cannot be adequately pre-medicated.
- History of cardiac transplantation.
- Contraindication to Transthoracic/Transesophageal Echocardiography (TTE/TEE).
- Endocarditis or severe infection within 12 months of scheduled implant procedure.
- Myocardial Infarction (MI), percutaneous coronary intervention (PCI), or known unstable angina within the 60 days prior to the index procedure.
- Cerebro-Vascular Accident within the previous 3 months.
- Hemodynamic instability or on IV inotropes.
- Contraindication to anticoagulant therapy and dual antiplatelet therapy.
- Documented history of bleeding diathesis, hypercoagulable or active peptic ulcer or gastrointestinal bleeding within 3 months of scheduled implant procedure.
- Severe renal impairment or on dialysis.
- Any condition that, in the opinion of the investigator, may render the subject unable to complete the study (e.g. life expectancy \< 1 year), or lead to difficulties for subject compliance with study requirements.
- Acute anemia.
- Chronic Oral Steroid Use ≥ 6 months.
- Pregnant or lactating female of childbearing potential with a positive pregnancy test 24 hours before any study-related radiation exposure.
- Pulmonary embolism within the last 6 months.
- Tricuspid Valve Tethering distance \> 10 mm.
- Presence of transvalvular pacemaker or defibrillator leads which are determined as immobile or interfering with the procedure, as evaluated by echocardiography.
- Inadequate TEE acoustic window for appropriate visualization of the tricuspid valve that is required for guiding the index implant procedure.
- Contra-indicated for blood transfusion or refuses transfusion.
- Patient undergoing emergency treatment.
- Patient without appropriate jugular access.
The study team makes the final eligibility decision.
Where it's taking place
- Hackensack, New Jersey, United States
- New York, New York, United States
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hackensack, New Jersey, United States; New York, New York, United States. 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.