Double Transseptal Guide Sheath to Prevent Dock Drop During SAPIEN M3 Transcatheter Mitral Valve Replacement

Study acronym: DGS-M3
StatusCompleted
PhaseNot specified
Started

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Record History

  1. Minor Study First Submitted
This study looks at a heart procedure called transcatheter mitral valve replacement. Doctors use a device called SAPIEN M3 to replace a damaged heart valve. The valve is replaced without open-heart surgery, through thin tubes guided to the heart. One step of the procedure can be harder in some patients. The new valve must be guided into place by a part called a "dock." In certain patients, the dock can land too low. This is called a "dock drop." It can make the procedure less successful. Doctors developed a new technique to prevent this problem. It is called the double transseptal guide sheath (DGS) technique. It uses two thin tubes during the procedure, instead of one. The two tubes lift the dock into a better position before the new valve is placed. Researchers reviewed medical records from 77 patients. These patients were treated at 16 hospitals across Europe. Some patients had heart anatomy that put them at higher risk for a low dock. These patients received the double-tube technique. Other patients received the standard, single-tube technique. The double-tube technique raised the dock to a safer position. This position was similar to patients with naturally lower-risk heart anatomy. The technique did not cause more complications than the standard technique. These findings suggest the double-tube technique may help prevent a low dock. This may benefit patients with higher-risk heart anatomy during this procedure.
Trial Details
NCT Number NCT07878195
Lead Sponsor Medical University of Vienna
Collaborators: Edwards Lifesciences
Conditions
(from sponsor)
Mitral Regurgitation
Related terms Heart Septal Defects, Atrial, Mitral Valve Insufficiency
Enrollment 77 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov