TriClip Japan Post-Approval Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: The TriClip System.
- Who it may be relevant to
- Registry conditions: Tricuspid Regurgitation. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective, Single-arm, Multi-center, Observational, Post-approval Study Designed to Confirm the Safety and Efficacy of the TriClip System in Japan.
Overview
The goal of this observational post approval study is to confirm the safety and efficacy of the TriClip System when used in routine clinical practice in the Japanese population and to fulfill post-market requirements following commercial approval in Japan.
Detailed description
Tricuspid Regurgitation (TR) is an abnormal condition which has both short-term and long-term consequences. TR decreases forward cardiac output and raises right-sided systemic venous pressures. This physiology will often result in hepatorenal congestion and dysfunction and, in addition, cause edema and ascites. The retrograde cardiac blood flow and volume loading also leads to further tricuspid dilatation exacerbating regurgitation over time.
The TriClip System is indicated for TR reduction in patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy, who are under the following conditions, as determined by a heart team:
* Patients with left-sided disease must be well treated according to the Japan guideline * Patients for whom tricuspid valve surgery is not the optimal treatment * Patients in whom transcatheter edge-to-edge valve repair is clinically appropriate
The objective of the TriClip Japan post-approval study is to confirm the safety and efficacy of the TriClip System for the treatment of symptomatic severe tricuspid regurgitation in a contemporary, real-world setting in the Japanese population, using the commercially available device in accordance with its approved indications for use.
Interventions
- Device The TriClip System
The TriClip System procedure will be performed in accordance with the Indication for Use (IFU) in Japan. The TriClip System is a transcatheter tricuspid valve repair system used to facilitate transcatheter edge-to-edge repair of the tricuspid valve leaflets and designed to deliver and deploy the Clip
Primary outcome measures
- Moderate or less Tricuspid Regurgitation (TR) at 30-day visit [Time frame: 30 days]
- Single Leaflet Device Attachment (SLDA) at 30-day visit [Time frame: 30 days]
Eligibility criteria
Inclusion criteria
- Subjects are eligible to receive the TriClip System per the current approved indications for use (IFU)
- Subjects provide written informed consent prior to conducting any investigation-specific procedures not considered standard of care.
Exclusion criteria
- There are no exclusion criteria
- Please note: It is not recommended that subjects enrolled in the study participate in any other therapeutic clinical study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Japan · 1 center
- National Cerebral & Cardiovascular Center Hospital — Suita
Identifiers
NCT: NCT07509658 · ABT-CIP-10613