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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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11 June 2018 |
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Main ID: |
ACTRN12617000829314 |
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Date of registration:
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06/06/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Clinical Trial Evaluation of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System
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Scientific title:
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Assessment of the All Cause Mortality at 30 days for Patients suffering from Tricuspid Regurgitation implanted with the Percutaneous 4Tech TriCinch Coil System |
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Date of first enrolment:
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28/08/2017 |
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Target sample size:
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90 |
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Recruitment status: |
Recruiting |
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URL:
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http://www.anzctr.org.au/ACTRN12617000829314.aspx |
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Study type:
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Interventional |
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Study design:
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Non-randomised trial
Single group |
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Phase:
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Phase 2
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Key inclusion & exclusion criteria
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Health Condition(s) or Problem(s) studied
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functional tricuspid regurgitation
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Intervention(s)
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Patients enrolled in this study with all eligibility criteria confirmed will be implanted with the TriCinch Coil System. This device offers a percutaneous treatment (access through the vein at the groin) to treat the leaking tricuspid valve, without the need for surgical intervention. This procedure is done by an interventional cardiologist or a cardiac surgeon under a general anaesthetic or deep sedation without the need for respiratory assistance and is expected to last 60-90 minutes initially.
The TriCinch Coil System implantation is as follows: 1) A delivery system that consists of a catheter (a hollow tube) that is attached to a handle is inserted in the patient's body through a vein in the groin. The delivery system contains a small anchor and a stent.
2) The small anchor is permanently placed in the wall of the tricuspid valve. The anchor is connected to a tensioning band that is connected to a stent at the opposite end. The stent (a mesh-like metal tube that expands, when deployed, to fit the patient's anatomy) is permanently deployed in a large vein called the inferior vena cave (IVC).
3) Then, the delivery system is removed and the procedure is complete.
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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