TRISCEND II Pivotal Trial

Edwards Lifesciences

Status: Active, not recruiting

Conditions: Heart Valve Diseases; Tricuspid Valve Insufficiency; Cardiovascular Diseases; Heart Failure; Tricuspid Valve Disease; Tricuspid Valve Regurgitation

Treatments: Device: Edwards EVOQUE System; Drug: Optimal Medical Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT04482062

2020-05

Details and patient eligibility

About

Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system

Full description

The study is a prospective, multi-center, randomized controlled pivotal clinical trial to evaluate the safety and effectiveness of the EVOQUE System with optimal medical therapy (OMT) compared to OMT alone in the treatment of patients with at least severe tricuspid regurgitation. Subjects will be followed at discharge, 30 days, 3 months, 6 months and annually through 5 years.

Enrollment: 1,070 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years old
• Despite medical therapy (OMT) per the local Heart Team, patient has signs of TR, symptoms from TR, or prior heart failure hospitalization from TR. Patient must be on OMT per the local heart team at the time of TR assessment for trial eligibility (TTE). OMT includes stable oral diuretic medications, unless patient has a documented history of intolerance.
• Functional and/or degenerative TR graded as at least severe on a transthoracic echocardiogram (assessed by the echo core lab using a 5-grade classification)
• The Local Heart Team determines that the patient is appropriate for transcatheter tricuspid valve replacement
• Patient is willing and able to comply with all study evaluations and provides written informed consent.

Exclusion criteria

• Anatomy precluding proper device delivery, deployment and/or function

• LVEF < 25%

• Evidence of severe right ventricular dysfunction

• Any of the following pulmonary pressure parameters:

  1. PASP >60 mmHg by echo Doppler (unless RHC demonstrates PASP ≤70 mmHg)
  2. PASP >70 mmHg by RHC
  3. PVR >5 Wood units by RHC (unless PVR ≤5 Wood units and systolic BP >85 mmHg after vasodilator challenge)

• Previous tricuspid surgery or intervention

• Presence of trans-tricuspid pacemaker or defibrillator lead with any of the following:

  1. Implanted in the RV within the last90 days
  2. Patient is pacemaker dependent5 on trans-tricuspid lead without alternative pacing option
  3. Has delivered appropriate ICD therapy

• Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation.

• Active endocarditis within the last 90 days or infection requiring antibiotic therapy (oral or intravenous) within the last 14 days

• Hemodynamically significant pericardial effusion

• Significant intra-cardiac mass, thrombus, or vegetation.

• Clinically significant, untreated coronary artery disease requiring revascularization, evidence of acute coronary syndrome, recent myocardial infarction within the last 30 days.

• Any of the following cardiovascular procedures:

  1. Percutaneous coronary, intracardiac, or endovascular intervention within the last 30 days
  2. Carotid surgery within the last 30 days
  3. Direct current cardioversion within the last 30 days
  4. Leadless RV pacemaker implant within the last 30 days
  5. Cardiac surgery within the last 90 days

• Known history of untreated severe symptomatic carotid stenosis (>50% by ultrasound) or asymptomatic carotid stenosis (>70% by ultrasound)

• Need for emergent or urgent surgery for any reason, any planned cardiac surgery within the next 12 months (365days), or any planned percutaneous cardiac procedure within the next 90 days

• Hypotension (systolic pressure <90 mmHg) or requirement for inotropic support or hemodynamic support within the last 30 days

• Patient with refractory heart failure requiring or which required advanced intervention (i.e. left ventricular assist device, transplantation) (ACC/AHA/ESC/EACTS Stage D heart failure)

• Deep vein thrombosis (DVT) or pulmonary embolism (PE) in the last 6 months (180 days)

• Stroke within the last 90 days

• Modified Rankin Scale ≥ 4 disability

• Severe renal insufficiency with estimated glomerular filtration rate (eGFR) ≤ 25 mL/min/1.73m2 or requiring chronic renal replacement therapy.

• Patients with hepatic insufficiency or cirrhosis with Child-Pugh score class C

• Patient is oxygen-dependent or requires continuous home oxygen

• Chronic anemia with transfusion dependency or Hgb < 9 g/dL not corrected by transfusion

• Unable to walk at least 100 meters in a 6-minute walk test

• Thrombocytopenia (Platelet count < 75,000/mm3) or thrombocytosis (Platelet count > 750,000/mm3)

• Known bleeding or clotting disorders or patient refuses blood transfusion

• Active gastrointestinal (GI) bleeding within the last 90 days

• Pregnant, breastfeeding, or planning pregnancy within the next 12 months (365 days).

• Patients in whom (any of the following):

  1. TEE is contraindicated or cannot be completed
  2. tricuspid valve anatomy is not evaluable by TTE or TEE

• In the opinion of the investigator, access to and through the femoral vein/IVC with a guide sheath and delivery catheter is deemed not feasible (e.g. occluded femoral veins, occluded or thrombosed IVC filter)

• Untreatable hypersensitivity or contraindication to any of the following: all antiplatelets, all anticoagulants, nitinol alloys (nickel and titanium), bovine tissue, glutaraldehyde, or contrast media

• Currently participating in another investigational biologic, drug or device study

• Co-morbid condition(s) that, in the opinion of the Investigator, limit life expectancy to < 12 months (365 days).

• Presence of infiltrative cardiomyopathy or valvulopathy (including carcinoid, amyloidosis, sarcoidosis, hemochromatosis) or significant uncorrected congenital heart disease (including but not limited to hemodynamically significant atrial septal defect, RV dysplasia, and arrhythmogenic RV)

• Any condition, in the opinion of the investigator, making it unlikely the patient will be able to complete all protocol procedures and follow-ups

• Other medical, social, or psychological conditions that preclude appropriate consent and follow-up, including patients under guardianship

• Any patient considered to be vulnerable

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,070 participants in 4 patient groups

Edwards EVOQUE System & OMT

Experimental group

Description:

Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation

Treatment:

Device: Edwards EVOQUE System

Optimal Medical Therapy (OMT)

Active Comparator group

Description:

Optimal medical therapy (OMT) alone in patients with tricuspid regurgitation

Treatment:

Drug: Optimal Medical Therapy

Single-Arm Registry

Experimental group

Description:

Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation who are not eligible for randomization

Treatment:

Device: Edwards EVOQUE System

Continued Access Study

Experimental group

Description:

Provides continued access to transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation.

Treatment:

Device: Edwards EVOQUE System