Mitral Prosthetic Valve Stenosis and RegurgitationSURVIVNCT04402931
Redo Surgery or Transcatheter Valve-in-Valve for Mitral Bioprosthetic Dysfunction (SURViV)
A study testing Transcatheter Valve-in-Valve Intervention and Redo Mitral valve surgery in people with Mitral Prosthetic Valve Stenosis and Regurgitation, run by Instituto Dante Pazzanese de Cardiologia at 7 sites in Brazil.
Trial summary
Transcatheter valve-in-valve implantation has emerged as a valid alternative to redo surgery for patients with surgical bioprosthetic dysfunction. Nowadays, transcatheter, transeptal mitral valve-in-valve replacement (TsMViV) has been adopted in many centers worldwide. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Mitral Prosthetic Valve Stenosis and Regurgitation
- What is being tested?
- Transcatheter Valve-in-Valve Intervention and Redo Mitral valve surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 7 sitesBrazil
- Study dates
- 17 Feb 2020to 1 Aug 2025
- Phase
- Interventional
- 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age>18 years;
- Symptoms of heart failure NYHA class>ll;
- Severe mitral bioprosthetic dysfunction (stenosis, regurgitation, mixed) defined by echocardiography;
- Heart team (including cardiac surgeon) agree on eligibility including assessment that transeptal, transcatheter mitral valve replacement (TsMVR) and redo surgical mitral valve replacement (rSMVR) are appropriate;
- The study patient or the study patient's legal representative informed of the nature of the study, agreed to its provisions and provided written informed consent as approved by the Institutional Review Board (IRB) center;
- The study patient agreed to comply with all required post- procedure follow-up visits including annual visits through 10 years and analysis close date visits, which was conducted as a phone follow-up;
- Heart team agreed (a priori) on treatment strategy for concomitant coronary disease (if present);
- Patient agreed to undergo redo surgical mitral valve replacement (rSMVR) if randomized to control treatment.
Who cannot join
- Heart Team assessment of inoperability (including examining cardiac surgeon);
- Hostile chest;
- Evidence of an acute myocardial infarction < 1 month (30 days) before the intended treatment [defined as: Q wave Ml, or non-Q wave Ml with total creatine kinase (CK), creatine kinase MB isoform (CK-MB) and/or cardiac troponin elevations (WHO definition)];
- Concomitant severe valvular disease (aortic, tricuspid or pulmonic) requiring surgical intervention;
- Mitral mechanical prosthesis or mitral valve rings;
- Preexisting mechanical or bioprosthetic valve in other position with severe dysfunction;
Show all 23Show fewer
- Complex coronary artery disease: unprotected left main coronary artery, Syntax score > 32 (in the absence of prior revascularization);
- Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease). Implantation of a permanent pacemaker is not an exclusion criteria;
- Patients with planned concomitant surgical or transcatheter ablation for atrial fibrillation;
- Leukopenia (WBC < 3000 cell/mL), acute anemia (Hgb< 9 g/dL), thrombocytopenia (Pht< 50,000 cell/mL);
- Hypertrophic cardiomyopathy with or without obstruction (HOCM);
- Predicted neo-LVOT area < 170 mm2 without feasible augmentation strategies;
- Severe ventricular dysfunction with left-ventricular ejection fraction (LVEF) < 20%;
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation;
- Active upper gastrointestinal (GI) bleeding within 3 months (90 days) prior to procedure;
- A known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure;
- Clinically (by neurologist) or neuroimaging confirmed stroke or transient ischemic attack (TIA) within 3 months (90 days) of the procedure;
- Renal insufficiency (creatinine > 3.0 mg/dL) and/or renal replacement therapy at the time of screening;
- Estimated life expectancy < 24 months (730 days) due to carcinomas, chronic liver disease, chronic renal disease or chronic end stage pulmonary disease;
- Currently participating in an investigational drug or another device study;
- Active bacterial endocarditis within 6 months (180 days) of procedure;
- Patient refuses redo mitral valve replacement surgery.
- Pregnancy
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Brazil7 sites
Hospital de Messejana Dr. Carlos Alberto Studart Gomes
Fortaleza, Ceará, 60840285
Instituto Nacional de Cardiologia
Rio de Janeiro, Rio de Janeiro, 22240006
Hospital Ana Nery
Salvador, Estado de Bahia, 41745900
Instituto de Cardiologia de Santa Catarina
São José, Santa Catarina, 88103901
UNIFESP
São Paulo, São Paulo, 04021001
Instituto do Coração (INCOR)
São Paulo, São Paulo, 05403900
Instituto Dante Pazzanese de Cardiologia
São Paulo, 04012909
About this study
Official title: Randomized Trial of Transcatheter Valve-in-Valve Intervention vs Redo Surgery for the Treatment of Structural Mitral Bioprosthetic Dysfunction
Transcatheter valve-in-valve implantation has emerged as a valid alternative to redo surgery for patients with surgical bioprosthetic dysfunction. Nowadays, transcatheter, transeptal mitral valve-in-valve replacement (TsMViV) has been adopted in many centers worldwide. Some studies report low rates of periprocedural morbidity and mortality and favorable hemodynamic parameters of valve performance. However, acute, medium and long-term data on TsMViV as compared to redo surgical mitral valve replacement (rSMVR) is not yet established. In particular, late prosthesis durability and hemodynamic performance after TsMViV are largely unknown and need to be elucidated before widely indicated, especially among younger and low-risk surgical candidates with failed mitral bioprostheses.
Read the detailed description
Prospective, randomized, controlled trial of transeptal, transcatheter mitral valve-in-valve versus redo surgical mitral valve replacement.
After multidisciplinary, heart team discussion, patients meeting inclusion criteria will be randomized 1:1 to receive either transcatheter, transeptal mitral valve-in-valve replacement (TsMViV) with the SAPIEN 3 transcatheter heart valve (THV) or redo, mitral valve replacement with commercially available surgical bioprosthetic valves. A sub-randomization in the surgical group will define which bioprosthetic valve will be used. Patients will be seen for follow-up visits at discharge, 30 days, 3 months and annually through 10 years.
- Being tested
- Transcatheter Valve-in-Valve Intervention, Redo Mitral valve surgery
- Keywords
- Mitral Prosthetic valve dysfunction
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Valve-in-Valve InterventionProcedure or surgery
Transcatheter mitral valve-in-valve implantation with SAPIEN 3
Redo Mitral valve surgeryProcedure or surgery
Transcatheter Valve-in-Valve Intervention
| Study group | Role | What they receive |
|---|---|---|
| Transcatheter Valve-in-Valve Intervention | Other | Transcatheter Valve-in-Valve Intervention Receives: Procedure: Transcatheter Valve-in-Valve Intervention |
| Redo Surgery | Other | Surgical Mitral valve replacement Receives: Procedure: Redo Mitral valve surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Combined Major cardiovascular and Cerebrovascular events
Death from any cause or Disabling Stroke
Measured: 12 months
Secondary outcomes (6)
Rate of Procedure-related complications
- Death from any cause;
- Disabling stroke
- Major vascular complications;
- Life-threatening, extensive or severe bleeding;
- New-onset atrial fibrillation;
- Acute renal failure (AKIN) stage 2 or 3;
- Cardiovascular mortality;
- Reoperation from any cause
Measured: 30 days
Rate of Rehospitalization
Rehospitalization from all-causes and cardiovascular causes at 12 months
Measured: 12 months
Rate of Prosthetic Thrombosis
Prosthetic thrombosis at 3- and 12 months (as assessed by transesophageal echocardiography and multi-slice tomography).
Measured: 3 and 12 months
Rate of Structural Valve Dysfunction (as assessed by transthoracic echocardiography)
Structural valve dysfunction assessed annually, up to 10-year follow-up.
Measured: 10 years
Rate of Bioprosthetic Valve Failure (as assessed by clinical outcomes and echocardiographic evaluations)
Bioprosthetic valve failure assessed annually, up to 10-year follow-up.
Measured: 10 years
Change in Health Status
New York Heart Association (NYHA) class and Quality-of-life measures (EuroQol 5D5L)
Measured: 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start17 Feb 2020
- Primary completion1 Feb 2024
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mitral Prosthetic Valve Stenosis and RegurgitationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Dante Pazzanese de Cardiologia
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards Lifesciences
- Responsible party
- Principal investigator, DIMYTRI ALEXANDRE DE ALVIM SIQUEIRA, Instituto Dante Pazzanese de Cardiologia
- Investigators
- Dimytri A Siqueira, MD, PhD, Principal investigator, Instituto Dante Pazzanese de Cardiologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04402931
- Sponsor's protocol ID
- 4993/2019
- Acronym
- SURVIV
- Status last verified
- Jun 2026
- First submitted
- 9 May 2020
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Siqueira DA, Abizaid AAC, Ramos AA, Issa M, Cervone AC, Bezerra CG, de Araripe Falcao BA, Cortes LA, de Freitas C Guimaraes L, K Sao Thiago LE, Rezende M, Delamain TR, Togna DD, Assef JE, Vilela AA, Paladino AT, Pinto IM, Franchini K, Bhatt DL, Feres F. Transcatheter valve-in-valve versus redo-surgical valve replacement for mitral bioprosthetic valve dysfunction: rationale and design of the SURVIV randomised trial. EuroIntervention. 2026 Mar 16;22(6):e358-e366. doi: 10.4244/EIJ-D-25-01090.
PubMed 41834775
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Transcatheter Valve-in-Valve Intervention vs Redo Surgery for the Treatment of Structural Mitral Bioprosthetic Dysfunction
- ClinicalTrials.gov ID
- NCT04402931
- Acronym / sponsor ID
- SURVIV / 4993/2019
- Keywords
- Mitral Prosthetic valve dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Instituto Dante Pazzanese de CardiologiaUniversity, hospital or other
- Collaborators
- Edwards Lifesciences
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 27 May 2020 (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.
Transcatheter valve-in-valve implantation has emerged as a valid alternative to redo surgery for patients with surgical bioprosthetic dysfunction. Nowadays, transcatheter, transeptal mitral valve-in-valve replacement (TsMViV) has been adopted in many centers worldwide. Some studies report low rates of periprocedural morbidity and mortality and favorable hemodynamic parameters of valve performance. However, acute, medium and long-term data on TsMViV as compared to redo surgical mitral valve replacement (rSMVR) is not yet established. In particular, late prosthesis durability and hemodynamic performance after TsMViV are largely unknown and need to be elucidated before widely indicated, especially among younger and low-risk surgical candidates with failed mitral bioprostheses.
Detailed description
Prospective, randomized, controlled trial of transeptal, transcatheter mitral valve-in-valve versus redo surgical mitral valve replacement.
After multidisciplinary, heart team discussion, patients meeting inclusion criteria will be randomized 1:1 to receive either transcatheter, transeptal mitral valve-in-valve replacement (TsMViV) with the SAPIEN 3 transcatheter heart valve (THV) or redo, mitral valve replacement with commercially available surgical bioprosthetic valves. A sub-randomization in the surgical group will define which bioprosthetic valve will be used. Patients will be seen for follow-up visits at discharge, 30 days, 3 months and annually through 10 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcatheter Valve-in-Valve Intervention | Other | Procedure: Transcatheter Valve-in-Valve InterventionTranscatheter Valve-in-Valve Intervention |
| Redo Surgery | Other | Procedure: Redo Mitral valve surgerySurgical Mitral valve replacement |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Age>18 years;
- Symptoms of heart failure NYHA class>ll;
- Severe mitral bioprosthetic dysfunction (stenosis, regurgitation, mixed) defined by echocardiography;
- Heart team (including cardiac surgeon) agree on eligibility including assessment that transeptal, transcatheter mitral valve replacement (TsMVR) and redo surgical mitral valve replacement (rSMVR) are appropriate;
- The study patient or the study patient's legal representative informed of the nature of the study, agreed to its provisions and provided written informed consent as approved by the Institutional Review Board (IRB) center;
Key exclusion criteria (23 listed)
- Heart Team assessment of inoperability (including examining cardiac surgeon);
- Hostile chest;
- Evidence of an acute myocardial infarction < 1 month (30 days) before the intended treatment [defined as: Q wave Ml, or non-Q wave Ml with total creatine kinase (CK), creatine kinase MB isoform (CK-MB) and/or cardiac troponin elevations (WHO definition)];
- Concomitant severe valvular disease (aortic, tricuspid or pulmonic) requiring surgical intervention;
- Mitral mechanical prosthesis or mitral valve rings;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter Valve-in-Valve InterventionTranscatheter mitral valve-in-valve implantation with SAPIEN 3 | Procedure or surgery | Transcatheter Valve-in-Valve Intervention |
| Redo Mitral valve surgeryTranscatheter Valve-in-Valve Intervention | Procedure or surgery | Redo Surgery |
Primary outcome
Rate of Combined Major cardiovascular and Cerebrovascular events
Time frame: 12 months
Death from any cause or Disabling Stroke
6 secondary outcomes
Rate of Procedure-related complications
Time frame: 30 days
Rate of Rehospitalization
Time frame: 12 months
Rate of Prosthetic Thrombosis
Time frame: 3 and 12 months
Rate of Structural Valve Dysfunction (as assessed by transthoracic echocardiography)
Time frame: 10 years
Rate of Bioprosthetic Valve Failure (as assessed by clinical outcomes and echocardiographic evaluations)
Time frame: 10 years
Change in Health Status
Time frame: 3 and 12 months
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 30 Jun 2026.
- Derived from this study: PubMed 41834775Siqueira DA, Abizaid AAC, Ramos AA, Issa M, Cervone AC, Bezerra CG, de Araripe Falcao BA, Cortes LA, de Freitas C Guimaraes L, K Sao Thiago LE, Rezende M, Delamain TR, Togna DD, Assef JE, Vilela AA, Paladino AT, Pinto IM, Franchini K, Bhatt DL, Feres F. Transcatheter valve-in-valve versus redo-surgical valve replacement for mitral bioprosthetic valve dysfunction: rationale and design of the SURVIV randomised trial. EuroIntervention. 2026 Mar 16;22(6):e358-e366. doi: 10.4244/EIJ-D-25-01090.
- Individual participant dataSharing planned: No
Related trials for Mitral Prosthetic Valve Stenosis and Regurgitation
Recruiting
Early Feasibility Study of Surgical Implantation of a Polymer Prosthetic Mitral and Aortic Valve
AORTIC VALVE DISEASES, Mitral Valve Disease
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.
Dimytri A Siqueira, MD, PhD principal investigator
Instituto Dante Pazzanese de Cardiologia
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter Valve-in-Valve Intervention and Redo Mitral valve surgery in people with Mitral Prosthetic Valve Stenosis and Regurgitation, run by Instituto Dante Pazzanese de Cardiologia at 7 sites in Brazil.
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 8 inclusion and 23 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 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Brazil. 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?
Rate of Combined Major cardiovascular and Cerebrovascular events (time frame: 12 months). 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 NCT04402931, which also lists 1 linked publication.
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 30 Jun 2026.