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TEER

TRICLIP™ TRANSCATHETER TRICUSPID VALVE REPAIR CLINICAL DATA

TriClip™ Transcatheter Edge-to-Edge Repair (TEER) offers a minimally invasive treatment option to improve quality of life (QoL) and functional status in patients with symptomatic severe tricuspid regurgitation, despite optimal medical therapy, who are at intermediate or greater risk for surgery.

THE STANDARD OF CARING FOR TR

TriClip TEER has shown meaningful outcomes in both real-world and randomized clinical data. The bRIGHT study and TRILUMINATE™ Pivotal Trial demonstrated the safety and effectiveness of TriClip TEER in the treatment of severe tricuspid regurgitation (TR).1,4

TRILUMINATE™ PIVOTAL TRIAL

Exceptional safety.1,2
Life-changing impact.1-4

The TRILUMINATE Pivotal Trial demonstrated that TriClip TEER Therapy was superior to medical therapy alone in reducing risk of heart failure hospitalization and improving quality of life.

Remarkable and sustained TR reduction3

TR grade (Core Lab)

 

  • Exceptional safety at 30 days1,3

    98.9%

    FREEDOM
    FROM MAEs

    0.9%

    NEW PACEMAKER
    IMPLANTATION

    0%

    DEVICE THROMBUS

    99.6%

    SURVIVAL

    0%

    NONELECTIVE CV
    SURGERY FROM
    DEVICE-RELATED AE

    0%

    DEVICE EMBOLIZATION

  • Significant improvement in health-related quality of life3
  • Baseline population characteristics5

    73%

    OF PATIENTS HAD MASSIVE
    OR TORRENTIAL TR

    4.3±0.8cm

    TRICUSPID VALVE
    ANNULUS DIAMETER

    38%

    OF PATIENTS WITH PRIOR
    MITRAL OR AORTIC VALVULAR INTERVENTION

    17%

    OF PATIENTS HAD A CRT, CRT-D, ICD, OR PERMANENT PACEMAKER

bRIGHT STUDY

Proven across a broad
range of anatomies4,6

The bRIGHT Study demonstrated that TriClip™ TEER significantly reduced TR across a broad range of anatomies - in a safe and effective procedure - resulting in durable and meaningful clinical outcomes.

Designed to maximize TR reduction2,4,7

TR grade (Core Lab)

 

  • Successfully treated a broad range of anatomies6
  • Proven durability backed by clinical data

    NYHA Functional Class7

    KCCQ - OS Score2

  • TriClip TEER demonstrated procedural success and an exceptional safety profile8

    HIGH PROCEDURAL
    SUCCESS

    99.0%

    Implant
    sucess rate

    SHORT
    DEVICE TIME
     

    76±39

    Minutes

    HIGH SAFETY
    PROFILE
     

    97.5%

    Freedom
    from MAEs
    at 30 days



    99.0% survival at 30 days

    0.2% TV reintervention

    0.0% embolization

     

TRILUMINATE™ TRIAL

Proven safety and effectiveness

The TRILUMINATE™ Trial demonstrated that TriClip TEER safely and effectively reduces TR and HF hospitalizations. 

93%

SURVIVAL
AT 1 YR10

100%

IMPLANT
SUCCESS10

91%

ACUTE PROCEDURAL
SUCCESS RATE10

0%

STROKE10
AT 30 DAYS

0%

CONVERSION TO
SURGERY10
AT 30 DAYS

  • Significant and durable TR reduction11

    Durable reduction in tricuspid regurgitation (TR)

  • Significant improvement in function and quality of life11

    Durable improvements in NYHA


    ≥10-point KCCQ-OS score improvement was observed in 50% of subjects at three years.11

MAT-2401620 v4.0 | Item approved for U.S. use only.

References
  1. Tang GHL, Hahn RT, Whisenant BK, et al. Tricuspid transcatheter edge-to-edge repair for severe tricuspid regurgitation: 1-year outcomes from the TRILUMINATE randomized cohort. J Am Coll Cardiol. Published online 2025;85(3):235-246. doi:10.1016/j.jacc.2024.10.08
  2. Lurz P, Rommel KP, Schmitz T, et al. Real-world 1-year results of tricuspid edge-to-edge repair from the bRIGHT study. J Am Coll Cardiol. 2024;84(7):607-616. doi:10.1016/j.jacc.2024.05.006
  3. Kar S, Makkar RR, Whisenant BK, et al. Two-year outcomes of transcatheter edge-to-edge repair for severe tricuspid regurgitation: The TRILUMINATE Pivotal Randomized Trial. Circulation. March 30, 2025. doi:10.1161/CIRCULATIONAHA.125.074536
  4. Estevez-Loureiro R. Real-world outcomes for tricuspid edge-to-edge repair: initial 2-year outcomes from the bRIGHT trial. Presented at PCR London Valves; November 19, 2023; London, England.
  5. Tang GHL, Hahn RT, Whisenant BK, et al. Tricuspid transcatheter edge-to-edge repair for severe tricuspid regurgitation: 1-year outcomes from the TRILUMINATE randomized cohort. J Am Coll Cardiol. Published online 2025; Suppl 1. Tables 1-13. doi:10.1016/j.jacc.2024.10.08
  6. Lurz P, Lapp H, Schueler R, et al. Real-world Outcomes for Tricuspid ​Edge-to-Edge Repair: Initial 30-Day Results from the TriClip™ bRIGHT Study. Presented at: EuroPCR; May 17-20, 2022; Paris, France​.
  7. Bekeredjian R. Real-World 2-Year Results of Tricuspid Edge-to-Edge Repair from the bRIGHT Study. Presented at EuroPCR 2025; Paris, France.
  8. Lurz P, Besler C, Schmitz T, et al. Short-term outcomes of tricuspid edge-to-edge repair in clinical practice. J Am Coll Cardiol. 2023;82(4):281-291. doi:10.1016/j.jacc.2023.05.008
  9. von Bardeleben RS, Lurz P, Sitges M, et al. Percutaneous edge-to-edge repair for tricuspid regurgitation: 2-year outcomes from the TRILUMINATE trial. Presented at: EuroPCR 2021.
  10. Lurz P, von Bardeleben RS, Weber M, et al. Transcatheter edge-to-edge repair for treatment of tricuspid regurgitation. J Am Coll Cardiol. 2021;77(3):229-239.
  11. Nickenig G. Percutaneous edge-to-edge repair for tricuspid regurgitation: 3-year outcomes from the TRILUMINATE trial. Presented at PCR London Valves on November 19-21, 2023; London, UK.
Important Safety Information

Rx Only

TRICLIP™ G5 SYSTEM

INDICATION FOR USE

The TriClip™ G5 System is indicated for improving quality of life and functional status in patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy, who are at intermediate or greater risk for surgery and in whom transcatheter edge-to-edge valve repair is clinically appropriate and is expected to reduce tricuspid regurgitation severity to moderate or less, as determined by a multidisciplinary heart team.

CONTRAINDICATIONS

The TriClip™ G5 System is contraindicated for use in patients with the following conditions: Intolerance, including allergy or untreatable hypersensitivity, to procedural anticoagulation; Untreatable hypersensitivity to Implant components (nickel-titanium alloy, cobalt-chromium alloy); Active endocarditis or other active infection of the tricuspid valve.

POTENTIAL ADVERSE EVENTS

The following events have been identified as possible complications of the TriClip™ G5 Procedure. Allergic reactions or hypersensitivity to latex, contrast agent, anaesthesia, device materials and drug reactions to anticoagulation, or antiplatelet drugs; Additional treatment / surgery from device-related complications; Bleeding; Blood disorders (including coagulopathy, hemolysis, and Heparin Induced Thrombocytopenia (HIT)); Cardiac arrhythmias (including conduction disorders, atrial arrhythmias, ventricular arrhythmias); Cardiac ischemic conditions (including myocardial infarction, myocardial ischemia, unstable angina, and stable angina); Cardiac perforation; Cardiac tamponade; Chest pain; Death; Dyspnea; Edema; Embolization (device or components of the device); Endocarditis; Fever or hyperthermia; Fluoroscopy and Transesophageal echocardiogram (TEE) -related complications: Skin injury or tissue changes due to exposure to ionizing radiation, Esophageal irritation, Esophageal perforation, Gastrointestinal bleeding; Hypotension / hypertension; Infection including: Septicemia; Nausea or vomiting; Pain; Pericardial effusion; Stroke / cerebrovascular accident (CVA) and transient ischemic attack (TIA); System organ failure: Cardio-respiratory arrest, Worsening heart failure, Pulmonary congestion, Respiratory dysfunction or failure or atelectasis, Renal insufficiency or failure, Shock (including cardiogenic and anaphylactic); Thrombosis; Tricuspid valve complications, which may complicate or prevent later surgical repair, including: Chordal entanglement / rupture, Single leaflet device attachment (SLDA), Dislodgement of previously implanted devices, Tissue damage, Tricuspid valve stenosis, Worsening, persistent or residual regurgitation; Vascular access complications which may require additional intervention, including: Wound dehiscence, Bleeding of the access site, Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation (rupture), vascular occlusion, Embolism (air, thrombus), Peripheral nerve injury; Venous thrombosis (including deep vein thrombosis) and thromboembolism (including pulmonary embolism).

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