An observational study in Mitral Regurgitation, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Medical University of Vienna · Observational
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.
Transcatheter mitral valve replacement (TMVR) with the balloon-expandable SAPIEN M3 system (Edwards Lifesciences) is an increasingly used treatment for patients with severe mitral regurgitation who are unsuitable for surgery or transcatheter edge-to-edge repair. The SAPIEN M3 system requires deployment of a docking coil within the native mitral apparatus before implantation of the valve itself. In patients with unfavorable papillary muscle anatomy, specifically a short distance between the papillary muscle heads and the mitral annulus, the docking coil can settle at an abnormally low position within the left ventricle, a phenomenon the investigators refer to as dock drop. A low dock position can compromise valve seating, device stability, and procedural success.
The double transseptal guide sheath (DGS) technique was developed as a procedural modification to mitigate dock drop in patients identified, by pre-procedural computed tomography assessment of papillary muscle height, as being at elevated anatomic risk. The technique employs a second transseptal sheath, introduced alongside the standard delivery sheath, to actively elevate the docking coil to a more favorable position before SAPIEN M3 valve deployment, rather than relying on the coil settling passively within native anatomy as occurs with the standard single guide sheath (SGS) technique.
This is a retrospective, multicenter cohort study conducted through the European SAPIEN M3 Double Guide Sheath Consortium, comprising 16 participating centers across Europe with experience in the DGS technique. The study population consists of consecutive patients who underwent SAPIEN M3 TMVR at these centers, with technique selection (DGS versus SGS) made by the treating operator based on pre-procedural anatomic assessment rather than randomization or a prospective study protocol; because participating centers were selected on the basis of DGS experience, the relative proportion of DGS to SGS cases in this cohort does not reflect the real-world frequency of unfavorable papillary muscle anatomy.
Data were abstracted retrospectively from institutional records at each site, including baseline demographic and clinical characteristics, pre-procedural computed tomography measurements of papillary muscle anatomy, procedural details (including dock height before and after any elevation maneuver, transseptal puncture and atrial septal defect characteristics, and procedural complications), and echocardiographic and clinical outcomes from baseline to hospital discharge. The principal procedural objective evaluated is the degree to which the DGS technique corrects dock height in anatomically unfavorable patients relative to the dock height observed natively in SGS-treated patients with favorable anatomy, together with a comparison of periprocedural safety and in-hospital echocardiographic outcomes between the two techniques. This study was conducted in accordance with the Declaration of Helsinki and was approved by the institutional ethics committee at each participating center; specific eligibility criteria and outcome measures are detailed in the corresponding sections of this registration.
467 studies on the registry are indexed under Mitral Valve Insufficiency; 152 are open to participants now.
This study's enrollment of 77 is below the median of 152 across 169 observational studies indexed under Mitral Valve Insufficiency.
Browse Mitral Valve Insufficiency studies →Medical University of Vienna is the lead sponsor of 1,105 studies on the registry; 182 are open to participants now.
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Adult patients with severe mitral regurgitation who were unsuitable for surgical mitral valve repair or transcatheter edge-to-edge repair and underwent transcatheter mitral valve replacement with the Edwards SAPIEN M3 system at 16 European centers experienced with the double transseptal guide sheath technique. Patients were treated with either the double guide sheath (DGS) technique, used preferentially in those with high-risk papillary muscle anatomy for dock drop, or the standard single guide sheath (SGS) technique, at the treating operator's discretion.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- None beyond the inclusion criteria above
Patients with high-risk papillary muscle anatomy for dock drop who underwent SAPIEN M3 transcatheter mitral valve replacement using the double transseptal guide sheath technique, in which a second transseptal guide sheath is used to actively elevate the docking coil to a more favorable position before valve deployment.
Patients with favorable papillary muscle anatomy who underwent SAPIEN M3 transcatheter mitral valve replacement using the standard single guide sheath implantation technique, without active elevation of the docking coil.
Incidence of a Composite Safety Endpoint (In-Hospital Death, Device Embolization, Major Procedural Complications, or Mitral Valve Reintervention)
A composite of in-hospital death, device embolization, major procedural complications, and mitral valve reintervention.
Time frame: From the time of the index procedure until hospital discharge, assessed up to 30 days post-procedure
Post-Procedural Residual Mitral Regurgitation Grade and Mean Transmitral Pressure Gradient
Residual mitral regurgitation grade and mean transmitral pressure gradient (mmHg), both assessed on post-procedural transthoracic echocardiography
Time frame: From the time of the index echocardiography until hospital discharge, assessed up to 30 days post-procedure
Pre-Procedural Papillary Muscle Height and Final Intraprocedural Dock Height
Pre-procedural papillary muscle height (distance from the mitral annular plane to the highest point of the papillary muscle head, measured on gated cardiac CT at end-diastole and end-systole) and final dock height (distance from the mitral annular plane to the lateral aspect of the docking coil on intraprocedural transesophageal echocardiography, recorded as the last measured value before valve release).
Time frame: Baseline CT (pre-procedural, not older than 6 months) and intraprocedurally before valve release
Diameter of Iatrogenic Atrial Septal Defect(s) at the Transseptal Puncture Site(s)
Diameter of the iatrogenic atrial septal defect(s), measured at the transseptal puncture site(s)
Time frame: Intraprocedural
Frequency of Iatrogenic Atrial Septal Defect Closure
Proportion of patients in whom the iatrogenic atrial septal defect at the transseptal puncture site closed spontaneously or was closed
Time frame: Intraprocedural, with follow-up assessment through hospital discharge (up to 30 days post-procedure)
Incidence of Site-Reported Acute Kidney Injury, Major Vascular Bleeding, Shock, or Cardiac Tamponade
Acute kidney injury, major vascular bleeding, shock, and cardiac tamponade, recorded by each site without a centrally applied staging definition or core laboratory adjudication.
Time frame: During index hospitalization and up to 30 days post-procedure.
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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