Mitral RegurgitationDGS-M3NCT07878195
Double Transseptal Guide Sheath to Prevent Dock Drop During SAPIEN M3 Transcatheter Mitral Valve Replacement
An observational study of Mitral Regurgitation, run by Medical University of Vienna at 1 site in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation
- How many people
- 77 participants
- Where
- 1 siteAustria
- Study dates
- 18 Dec 2024to 18 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Adult patients with severe mitral regurgitation deemed unsuitable for mitral valve surgery or transcatheter edge-to-edge repair
- Underwent transcatheter mitral valve replacement with the Edwards SAPIEN M3 system at one of the 16 participating centers of the European SAPIEN M3 Double Guide Sheath Consortium
- Treated using either the double transseptal guide sheath (DGS) technique or the standard single guide sheath (SGS) technique, with technique selection made at operator discretion based on pre-procedural computed tomography assessment of papillary muscle anatomy
- Consecutive patients undergoing the index SAPIEN M3 procedure at a participating center during the study period (December 2024 to August 2026)
Who cannot join
- None beyond the inclusion criteria above
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double Transseptal Guide Sheath to Prevent Dock Drop During SAPIEN M3 Transcatheter Mitral Valve Replacement: A Retrospective Multicenter Analysis From the European SAPIEN M3 Double Guide Sheath Consortium
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Mitral Regurgitation
- Keywords
- SAPIEN M3, Transcatheter Mitral Valve Replacement, TMVR, Double Transseptal Guide Sheath, Dock Drop, Guide Sheath, Transseptal Puncture, Papillary Muscle Anatomy, Mitral Valve Replacement, Atrial Septal Defect
- Medical subject headings
- Mitral Valve Insufficiency, Heart Septal Defects, Atrial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| DGS (Double Transseptal Guide Sheath) | 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. | |
| SGS (Standard Single Guide Sheath) | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: From the time of the index echocardiography until hospital discharge, assessed up to 30 days post-procedure
Secondary outcomes (4)
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).
Measured: 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)
Measured: 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
Measured: 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.
Measured: During index hospitalization and up to 30 days post-procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start18 Dec 2024
- Primary completion18 Aug 2026
- Study completion18 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards Lifesciences
- Responsible party
- Principal investigator, Varius Dannenberg, Medical University of Vienna
- Investigators
- Varius Dannenberg, MD, PhD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878195
- Sponsor's protocol ID
- MUW-1634/2026
- Acronym
- DGS-M3
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41167201Forrestal 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.
PubMed 33667453Stone 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.
PubMed 30280640Makkar 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.
PubMed 37219553Feldman 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.
PubMed 21463154Hausleiter 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.
PubMed 36688459Praz 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.
PubMed 40878295Writing 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.
PubMed 33342586Bartko 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.
PubMed 34193442Dziadzko 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.
PubMed 29536860d'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.
PubMed 27354049Nkomo 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.
PubMed 16980116
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Transseptal Guide Sheath to Prevent Dock Drop During SAPIEN M3 Transcatheter Mitral Valve Replacement: A Retrospective Multicenter Analysis From the European SAPIEN M3 Double Guide Sheath Consortium
- ClinicalTrials.gov ID
- NCT07878195
- Acronym / sponsor ID
- DGS-M3 / MUW-1634/2026
- Conditions
- Mitral Regurgitation
- Keywords
- SAPIEN M3, Transcatheter Mitral Valve Replacement, TMVR, Double Transseptal Guide Sheath, Dock Drop, Guide Sheath, Transseptal Puncture, Papillary Muscle Anatomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Edwards Lifesciences
- Study start
- 18 Dec 2024 (actual)
- Primary completion
- 18 Aug 2026 (actual)
- Study completion
- 18 Aug 2026 (actual)
- First posted
- 16 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DGS (Double Transseptal Guide Sheath) | – | –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. |
| SGS (Standard Single Guide Sheath) | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- Adult patients with severe mitral regurgitation deemed unsuitable for mitral valve surgery or transcatheter edge-to-edge repair
- Underwent transcatheter mitral valve replacement with the Edwards SAPIEN M3 system at one of the 16 participating centers of the European SAPIEN M3 Double Guide Sheath Consortium
- Treated using either the double transseptal guide sheath (DGS) technique or the standard single guide sheath (SGS) technique, with technique selection made at operator discretion based on pre-procedural computed tomography assessment of papillary muscle anatomy
- Consecutive patients undergoing the index SAPIEN M3 procedure at a participating center during the study period (December 2024 to August 2026)
Key exclusion criteria (1 listed)
- None beyond the inclusion criteria above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of a Composite Safety Endpoint (In-Hospital Death, Device Embolization, Major Procedural Complications, or Mitral Valve Reintervention)
Time frame: From the time of the index procedure until hospital discharge, assessed up to 30 days post-procedure
A composite of in-hospital death, device embolization, major procedural complications, and mitral valve reintervention.
Post-Procedural Residual Mitral Regurgitation Grade and Mean Transmitral Pressure Gradient
Time frame: From the time of the index echocardiography until hospital discharge, assessed up to 30 days post-procedure
Residual mitral regurgitation grade and mean transmitral pressure gradient (mmHg), both assessed on post-procedural transthoracic echocardiography
4 secondary outcomes
Pre-Procedural Papillary Muscle Height and Final Intraprocedural Dock Height
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)
Time frame: Intraprocedural
Frequency of Iatrogenic Atrial Septal Defect Closure
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
Time frame: During index hospitalization and up to 30 days post-procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Background: PubMed 41167201Guerrero 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.
- Background: PubMed 33667453Forrestal 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.
- Background: PubMed 30280640Stone 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.
- Background: PubMed 37219553Makkar 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.
- Background: PubMed 21463154Feldman 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.
- Background: PubMed 36688459Hausleiter 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.
- Background: PubMed 40878295Praz 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.
- Background: PubMed 33342586Writing 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.
- Background: PubMed 34193442Bartko 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.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Varius Dannenberg, MD, PhD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Regurgitation, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of a Composite Safety Endpoint (In-Hospital Death, Device Embolization, Major Procedural Complications, or Mitral Valve Reintervention) (time frame: From the time of the index procedure until hospital discharge, assessed up to 30 days post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07878195, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.