NCT07878195|Completed
Double Transseptal Guide Sheath to Prevent Dock Drop During SAPIEN M3 Transcatheter Mitral Valve Replacement
DGS-M3
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DGS-M3
Sponsor study identifier
observational
77
1 country
1
Study Start
December 18, 2024
Actual (reported)Primary Completion
August 18, 2026
Actual (reported)Study Completion
August 18, 2026
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 18, 2026
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 18, 2024
Actual (reported)August 18, 2026
Actual (reported)August 18, 2026
Actual (reported)October 1, 2026
Actual (reported)October 16, 2026
Actual (reported)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.
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
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
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)
Intraprocedural
Frequency of Iatrogenic Atrial Septal Defect Closure
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
During index hospitalization and up to 30 days post-procedure.
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.
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.
Medical University of Vienna
Vienna, State of Vienna, 1090, Austria
Guerrero ME, Daniels DV, Makkar RR, Thourani VH, Asch FM, Pham M, Muhammad KI, Greenbaum AB, Vasquez A, Oldemeyer JB, Dahle TG, Rihal C, Morse MA, Rodriguez E, O'Neill BP, Russo M, Whisenant B, Yadav P, Yu X, Wang DD, Makar M, Baran DA, Mahoney P, Reddy G, Blanke P, Webb J; ENCIRCLE Trial Executive Committee and Study Investigators. Percutaneous transcatheter valve replacement in individuals with mitral regurgitation unsuitable for surgery or transcatheter edge-to-edge repair: a prospective, multicountry, single-arm trial. Lancet. 2025 Nov 29;406(10519):2541-2550. doi: 10.1016/S0140-6736(25)02073-2. Epub 2025 Oct 27.
Forrestal BJ, Khan JM, Torguson R, Case BC, Safren L, Nasher N, Reddin G, Satler L, Ben-Dor I, Shults C, Collins EC, Rogers T, Waksman R. Reasons for Screen Failure for Transcatheter Mitral Valve Repair and Replacement. Am J Cardiol. 2021 Jun 1;148:130-137. doi: 10.1016/j.amjcard.2021.02.022. Epub 2021 Mar 3.
Varius Dannenberg, MD, PhD
Medical University of Vienna
77 participants (actual enrollment reported by the registry).
First Submitted
October 1, 2026
First Posted
October 16, 2026
Study Start
December 18, 2024
Actual (reported)Clinical Outcomes of Edwards Lifesciences MITRIS RESLILA Mitral Valve in the Asian Population
Contact the study team to confirm eligibility.
Stone GW, Lindenfeld J, Abraham WT, Kar S, Lim DS, Mishell JM, Whisenant B, Grayburn PA, Rinaldi M, Kapadia SR, Rajagopal V, Sarembock IJ, Brieke A, Marx SO, Cohen DJ, Weissman NJ, Mack MJ; COAPT Investigators. Transcatheter Mitral-Valve Repair in Patients with Heart Failure. N Engl J Med. 2018 Dec 13;379(24):2307-2318. doi: 10.1056/NEJMoa1806640. Epub 2018 Sep 23.
Makkar RR, Chikwe J, Chakravarty T, Chen Q, O'Gara PT, Gillinov M, Mack MJ, Vekstein A, Patel D, Stebbins AL, Gelijns AC, Makar M, Bhatt DL, Kapadia S, Vemulapalli S, Leon MB. Transcatheter Mitral Valve Repair for Degenerative Mitral Regurgitation. JAMA. 2023 May 23;329(20):1778-1788. doi: 10.1001/jama.2023.7089.
Feldman T, Foster E, Glower DD, Kar S, Rinaldi MJ, Fail PS, Smalling RW, Siegel R, Rose GA, Engeron E, Loghin C, Trento A, Skipper ER, Fudge T, Letsou GV, Massaro JM, Mauri L; EVEREST II Investigators. Percutaneous repair or surgery for mitral regurgitation. N Engl J Med. 2011 Apr 14;364(15):1395-406. doi: 10.1056/NEJMoa1009355. Epub 2011 Apr 4.
Hausleiter J, Stocker TJ, Adamo M, Karam N, Swaans MJ, Praz F. Mitral valve transcatheter edge-to-edge repair. EuroIntervention. 2023 Jan 23;18(12):957-976. doi: 10.4244/EIJ-D-22-00725.
Praz F, Borger MA, Lanz J, Marin-Cuartas M, Abreu A, Adamo M, Ajmone Marsan N, Barili F, Bonaros N, Cosyns B, De Paulis R, Gamra H, Jahangiri M, Jeppsson A, Klautz RJM, Mores B, Perez-David E, Poss J, Prendergast BD, Rocca B, Rossello X, Suzuki M, Thiele H, Tribouilloy CM, Wojakowski W; ESC/EACTS Scientific Document Group. 2025 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2025 Nov 21;46(44):4635-4736. doi: 10.1093/eurheartj/ehaf194. No abstract available.
Writing Committee Members; Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP 3rd, Gentile F, Jneid H, Krieger EV, Mack M, McLeod C, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A, Toly C. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2021 Feb 2;77(4):e25-e197. doi: 10.1016/j.jacc.2020.11.018. Epub 2020 Dec 17. No abstract available.
Bartko PE, Heitzinger G, Pavo N, Heitzinger M, Spinka G, Prausmuller S, Arfsten H, Andreas M, Gabler C, Strunk G, Mascherbauer J, Hengstenberg C, Hulsmann M, Goliasch G. Burden, treatment use, and outcome of secondary mitral regurgitation across the spectrum of heart failure: observational cohort study. BMJ. 2021 Jun 30;373:n1421. doi: 10.1136/bmj.n1421.
Dziadzko V, Clavel MA, Dziadzko M, Medina-Inojosa JR, Michelena H, Maalouf J, Nkomo V, Thapa P, Enriquez-Sarano M. Outcome and undertreatment of mitral regurgitation: a community cohort study. Lancet. 2018 Mar 10;391(10124):960-969. doi: 10.1016/S0140-6736(18)30473-2.
d'Arcy JL, Coffey S, Loudon MA, Kennedy A, Pearson-Stuttard J, Birks J, Frangou E, Farmer AJ, Mant D, Wilson J, Myerson SG, Prendergast BD. Large-scale community echocardiographic screening reveals a major burden of undiagnosed valvular heart disease in older people: the OxVALVE Population Cohort Study. Eur Heart J. 2016 Dec 14;37(47):3515-3522. doi: 10.1093/eurheartj/ehw229. Epub 2016 Jun 26.
Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study. Lancet. 2006 Sep 16;368(9540):1005-11. doi: 10.1016/S0140-6736(06)69208-8.
Primary Completion
August 18, 2026
Actual (reported)Study Completion
August 18, 2026
Actual (reported)Last Updated
October 21, 2026
Record last verified: 2026-10
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