Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in Germany / NCT07586995
Recruiting Observational

A Post-Market Assessment of the Safety and Performance of the TriClip™ System

NCT07586995 · tracked via the Priya Life Science Germany tracker
Sponsor
Abbott Medical Devices
Phase
Observational
Started
2026-07-02
Last updated
2026-10-06

Condition(s) studied

Tricuspid Regurgitation (TR)

Investigational drug(s) / intervention(s)

Tricuspid Transcatheter Edge-to-Edge Repair (TEER)

Tricuspid Transcatheter Edge-to-Edge Repair (TEER): TriClip System

Study summary

The objective of the TREAT TR study is to confirm the safety and performance of the TriClip System for tricuspid TEER in a contemporary, real-world setting, using the commercially available device in accordance with its approved indications for use.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Subject is eligible to receive the TriClip System per the current approved indications for use and is intended to undergo the procedure. 2. Subject, or their legally authorized representative, has provided written informed consent prior to study procedure. 3. Subject agrees to attend follow-up assessments. 4. Subject is ≥ 18 years of age (or legal age of consent) at time of consent. Exclusion Criteria: 1. Subject is participating in another clinical study that could impact the follow-up or results of this study. 2. Subject has an existing TriClip implant 3. Presence of other conditions or factors that, in the Investigator's opinion, could limit the subject's ability to participate in follow-up.

Primary outcome measure(s)

  • Rate of Peri-Procedural Adverse Events — Through 30 days post-procedure
    Defined as all-cause mortality, device embolization, device thrombosis, non-elective surgery or transcatheter intervention for device- or procedure-related adverse event (AE) new pacemaker implantation and device- or procedure related major bleeding
  • Tricuspid Regurgitation (TR) grade less than or equal to moderate — At 30-day follow-up
  • Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) score improvement of at least 10 points — At 30-day follow-up
    All KCCQ scores are scaled from 0 (worst) to 100 (best possible status), where the higher score reflects a better health status.

Trial sites (9)

FacilityCityRegionStatus
Banner University Medical Center Phoenix Phoenix Arizona Recruiting
Scripps Health La Jolla California Recruiting
Northwestern Memorial Hospital Chicago Illinois Recruiting
Ascension Texas Cardiovascular Research Austin Texas Recruiting
Sentara Norfolk General Hospital Norfolk Virginia Recruiting
St. Johannes Hospital Dortmund N. Rhine Recruiting
Ospedale San Raffaele - Cardiac Milan Lombard Recruiting
Hospital Universitario Central de Asturias Oviedo Principality of Asturias Recruiting
Hospital Clínic de Barcelona Barcelona Spain Recruiting

More Abbott Medical Devices trials in Germany

Abbott Vascular Medical Device Registry Recruiting
Abbott Medical - VERITAS Study Active, not recruiting
BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF Recruiting
MitraClip REPAIR MR Study Active, not recruiting
ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation Enrolling by invitation

Other trials for the same condition

Pacemaker Implantation Following Transcatheter Tricuspid Valve Replacement Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07586995 on ClinicalTrials.gov ↗ ← All trials in Germany