Valve Heart DiseaseBASELINENCT04843072
Balloon vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis
A study testing EVOLUT R/PRO/PRO+/FX bioprosthesis, Edwards Sapien S3/Ultra bioprosthesis and MYVAL/Octacor/Octapro bioprosthesis in people with Valve Heart Disease, run by Erasmus Medical Center at 14 sites in 12 countries.
Trial summary
Transcatheter aortic valve implantation (TAVI) serves a growing spectrum of patients with symptomatic severe aortic stenosis (AS). Approximately 80% of surgical aortic valve replacements are performed using a bioprosthesis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Valve Heart Disease
- What is being tested?
- EVOLUT R/PRO/PRO+/FX bioprosthesis, Edwards Sapien S3/Ultra bioprosthesis and MYVAL/Octacor/Octapro bioprosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 14 sitesin 12 countries
- Study dates
- 1 May 2021to 1 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age ≥ 18 years
- Failing surgical aortic bioprosthesis requiring valve replacement and eligible for transfemoral TAVI with balloon expandable or self-expanding platform per heart team consensus based on multi-modality imaging assessment (including echocardiography and multidetector CT).
- Written informed consent
Who cannot join
- Not eligible for Transfemoral TAVI with EVOLUT, SAPIEN or MYVAL THV series
- Multi-valve defects requiring intervention
- Clinically unstable and/or inotropic/vasopressor /mechanical support.
- Known mural thrombus in the left ventricle
- Presence of a mechanical aortic valve
- History of recent (within 1 month) stroke or TIA
Trial locations and contacts
14 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
14 sites in 12 countries
Germany2 sites, 2 recruiting
- Recruiting
Division of Cardiology, Pulmonology, and Vascular Medicine, Heinrich Heine University Medical Center Dusseldorf, Dusseldorf, Germany
Düsseldorf
Verena Veulemans, MD PhD
- Not yet recruiting
University Hospital Mainz
Mainz
Stephan Von Bardeleben, MD
Stephan Von Bardeleben, MD
Italy2 sites, 2 recruiting
- Recruiting
Interventional Cardiology Unit, Cardiovascular Department, Fondazione Poliambulanza Institute, Brescia, Italy
Brescia
Diego Maffeo, MD PhD
- Not yet recruiting
University Hospital of Padova
Padua
Giusepe Tarantini, MD
Giusepe Tarantini, MD
United States1 site, 1 recruiting
- Recruiting
Cedars Sinai
Los Angeles, California, 90048
Raj Makkar, MD
Raj Makkar, MD
Austria1 site, 1 recruiting
- Recruiting
Vienna General Hospital
Vienna
Christian Hengstenberg, MD, PhD
Christian Hengstenberg, MD, PhD
Canada1 site, 1 recruiting
- Not yet recruiting
St Paul's and Vancouver General Hospital
Vancouver
John Webb, MD
John Webb, MD
Denmark1 site, 1 recruiting
- Not yet recruiting
Rigshospitalet
Copenhagen
Lars Sondergaard, MD
Lars Sondergaard, MD
France1 site, 1 recruiting
- Recruiting
Institut Cœur Poumon
Lille
Eric Van Belle, MD
Eric Van Belle, MD
Greece1 site, 1 recruiting
- Recruiting
Department of Cardiology, Onassis Cardiac Surgery Center, Athens, Greece
Athens
Ioannis Iakovou, MD PhD
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus Medical Centre
Rotterdam, 3015 GD
Rutger-Jan Nuis, +31614858291, r.nuis@erasmusmc.nl
Portugal1 site, 1 recruiting
- Recruiting
Centro Hospitalar de Lisboa Ocidental
Lisbon
Rui Teles, MD
Rui Teles, MD
Switzerland1 site, 1 recruiting
- Not yet recruiting
Inselspital, University Hospital
Bern
Thomas Pilgrim, MD
Thomas Pilgrim
United Kingdom1 site, 1 recruiting
- Not yet recruiting
Leeds Teaching Hospitals
Leeds
Daniel Blackman, MD
Daniel Blackman, MD
About this study
Official title: Balloon Expandable vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis. THE BASELINE TRIAL.
Transcatheter aortic valve implantation (TAVI) serves a growing spectrum of patients with symptomatic severe aortic stenosis (AS). Approximately 80% of surgical aortic valve replacements are performed using a bioprosthesis. Durability of surgical bioprostheses varies according to patient age at the time of implantation, prosthesis type and size, among other factors. TAVI has become an established treatment option for patients with a degenerated surgical aortic bioprosthesis. The time from index surgical aortic valve replacement (SAVR) to bioprosthetic valve degeneration is typically 8-10 years. TAVI in this setting has shown favorable outcomes. Balloon-expandable and self-expanding transcatheter heart valves (THVs) can both be used for the treatment of a degenerated surgical aortic bioprosthesis and have specific advantages and limitations. Valve-in-valve TAVI may be associated with coronary obstruction, THV migration, paravalvular regurgitation, and prosthesis-patient mismatch.
Objective:
Read more
To compare valve-in-valve TAVI with balloon-expandable SAPIEN/MYVAL THV series versus the self-expanding EVOLUT THV series. The primary analysis evaluates device success at 30 days in the primary cohort. Continued enrollment will additionally support a secondary comparison of the safety and efficacy of the SAPIEN and MYVAL THV series.
Study design: International multicenter randomized study with 1:1 randomization to TAVI with the EVOLUT THV series or the SAPIEN/MYVAL THV series.
Study population:
The primary cohort comprises 440 patients with a failing surgical aortic bioprosthesis (aortic stenosis with or without aortic regurgitation) selected for transfemoral TAVI by heart-team consensus. Enrollment of the primary cohort has been completed.
The continued-enrollment cohort comprises 160 additional patients and will increase the total study population to 600 patients, with a target distribution of 300 patients treated with the EVOLUT THV series, 150 with the SAPIEN THV series, and 150 with the MYVAL THV series.
Investigational intervention:
Transfemoral valve-in-valve TAVI with a balloon-expandable SAPIEN or MYVAL THV series or a self-expanding EVOLUT THV series.
Main study parameters/endpoints:
- Primary endpoint is device success at 30 days Defined by:
- Absence of procedural mortality; AND
- Technical success at exit from the procedure room defined as freedom from mortality, successful access, delivery of the device and retrieval of the delivery system, correct positioning of a single prosthetic heart valve into the proper anatomical location, and freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication; AND
- Intended performance of the prosthetic heart valve (no severe prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s, Doppler velocity index ≥0.25, and no moderate or severe prosthetic valve regurgitation). Severe prosthesis-patient mismatch is defined as an indexed effective orifice area (EOAi) ≤0.65 cm²/m² (≤0.55 cm²/m² if BMI ≥30 kg/m²).
- Safety endpoint at 1 year defined by the composite of all-cause death, disabling stroke, rehospitalization for heart failure, or valve-related problems.
- Secondary objective is comparison of the safety and efficacy of the SAPIEN versus MYVAL THV series, including the incidence of moderate or severe prosthesis-patient mismatch.
The continued-enrollment cohort is designed to support this comparison.
- Conditions
- Valve Heart Disease
- Being tested
- EVOLUT R/PRO/PRO+/FX bioprosthesis, Edwards Sapien S3/Ultra bioprosthesis, MYVAL/Octacor/Octapro bioprosthesis
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVOLUT R/PRO/PRO+/FX bioprosthesisDevice
To compare EVOLUT R/PRO/PRO+/FX bioprosthesis versus Edwards SAPIEN 3/Ultra bioprosthesis or Myval/Octacor/ Octapro in failing surgical bioprostheses
Edwards Sapien S3/Ultra bioprosthesisDevice
Edwards Sapien S3/Ultra bioprosthesis
MYVAL/Octacor/Octapro bioprosthesisDevice
MYVAL/Octacor/Octapro bioprosthesis
| Study group | Role | What they receive |
|---|---|---|
| EVOLUT R/PRO/PRO+/FX bioprosthesis | Experimental | Study subjects will receive a self-expanding valve from the EVOLUT THV series (EVOLUT R/PRO/PRO+/FX). Receives: Device: EVOLUT R/PRO/PRO+/FX bioprosthesis |
| SAPIEN 3/Ultra or MYVAL/Octacor/Octapro bioprosthesis | Active comparator | Study subjects will receive a balloon-expandable valve from either the SAPIEN THV series (SAPIEN 3, SAPIEN 3 Ultra) or the MYVAL THV series (Myval Octacor, Myval Octapro). Receives: Device: Edwards Sapien S3/Ultra bioprosthesis; Device: MYVAL/Octacor/Octapro bioprosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device success
Defined by:
- Absence of procedural mortality; AND
- Technical success at exit from the procedure room defined as freedom from mortality, successful access, delivery of the device and retrieval of the delivery system, correct positioning of a single prosthetic heart valve into the proper anatomical location, and freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication; AND
- Intended performance of the prosthetic heart valve (no severe prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s, Doppler velocity index ≥0.25, and no moderate or severe prosthetic valve regurgitation).
Severe prosthesis-patient mismatch is defined as an indexed effective orifice area (EOAi) ≤0.65 cm²/m² (≤0.55 cm²/m² if BMI ≥30 kg/m²).
Measured: 30 days post transcatheter valve implantation
Secondary outcomes (2)
Composite of all-cause death, disabling stroke, rehospitalization for heart failure or valve related problems
Safety endpoint
Measured: 1 year post transcatheter valve implantation
Moderate or severe prosthesis-patient mismatch
Moderate or severe prosthesis-patient mismatch is defined as EOAi ≤0.85 cm²/m² (≤0.70 cm²/m² if BMI ≥30 kg/m²). This endpoint will be compared between patients treated with the SAPIEN and MYVAL THV series.
Measured: 30 days post transcatheter valve implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start1 May 2021
- Primary completion1 Jun 2028 (estimated)
- Study completion1 May 2029 (estimated)
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 Valve Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cedars-Sinai Medical Center
- Responsible party
- Principal investigator, Rutger-Jan Nuis, Erasmus Medical Center
- Investigators
- Nicolas Van Mieghem, MD, PhD, Principal investigator, Erasmus Medical CentreRutger-Jan Nuis, MD, PhD, Principal investigator, Erasmus Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04843072
- Sponsor's protocol ID
- BASELINE TRIAL
- Acronym
- BASELINE
- Status last verified
- Oct 2026
- First submitted
- 24 Mar 2021
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Nuis RJ, van Belle E, Teles R, Blackman D, Veulemans V, Santos IA, Pilgrim T, Tarantini G, Saia F, Iakovou I, Mascherbauer J, Vincent F, Geleijnse M, Sathananthan J, Wood D, Makkar R, Van Mieghem NM; BASELINE Investigators. BAlloon expandable vs. SElf expanding transcatheter vaLve for degenerated bioprosthesIs: design and rationale of the BASELINE trial. Am Heart J. 2023 Feb;256:139-147. doi: 10.1016/j.ahj.2022.11.013. Epub 2022 Nov 19.
PubMed 36410441
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balloon Expandable vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis. THE BASELINE TRIAL.
- ClinicalTrials.gov ID
- NCT04843072
- Acronym / sponsor ID
- BASELINE / BASELINE TRIAL
- Conditions
- Valve Heart Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Cedars-Sinai Medical Center
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 13 Apr 2021 (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 aortic valve implantation (TAVI) serves a growing spectrum of patients with symptomatic severe aortic stenosis (AS). Approximately 80% of surgical aortic valve replacements are performed using a bioprosthesis. Durability of surgical bioprostheses varies according to patient age at the time of implantation, prosthesis type and size, among other factors. TAVI has become an established treatment option for patients with a degenerated surgical aortic bioprosthesis. The time from index surgical aortic valve replacement (SAVR) to bioprosthetic valve degeneration is typically 8-10 years. TAVI in this setting has shown favorable outcomes. Balloon-expandable and self-expanding transcatheter heart valves (THVs) can both be used for the treatment of a degenerated surgical aortic bioprosthesis and have specific advantages and limitations. Valve-in-valve TAVI may be associated with coronary obstruction, THV migration, paravalvular regurgitation, and prosthesis-patient mismatch.
Objective:
To compare valve-in-valve TAVI with balloon-expandable SAPIEN/MYVAL THV series versus the self-expanding EVOLUT THV series. The primary analysis evaluates device success at 30 days in the primary cohort. Continued enrollment will additionally support a secondary comparison of the safety and efficacy of the SAPIEN and MYVAL THV series.
Study design: International multicenter randomized study with 1:1 randomization to TAVI with the EVOLUT THV series or the SAPIEN/MYVAL THV series.
Study population:
The primary cohort comprises 440 patients with a failing surgical aortic bioprosthesis (aortic stenosis with or without aortic regurgitation) selected for transfemoral TAVI by heart-team consensus. Enrollment of the primary cohort has been completed.
The continued-enrollment cohort comprises 160 additional patients and will increase the total study population to 600 patients, with a target distribution of 300 patients treated with the EVOLUT THV series, 150 with the SAPIEN THV series, and 150 with the MYVAL THV series.
Investigational intervention:
Transfemoral valve-in-valve TAVI with a balloon-expandable SAPIEN or MYVAL THV series or a self-expanding EVOLUT THV series.
Main study parameters/endpoints:
- Primary endpoint is device success at 30 days Defined by:
- Absence of procedural mortality; AND
- Technical success at exit from the procedure room defined as freedom from mortality, successful access, delivery of the device and retrieval of the delivery system, correct positioning of a single prosthetic heart valve into the proper anatomical location, and freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication; AND
- Intended performance of the prosthetic heart valve (no severe prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s, Doppler velocity index ≥0.25, and no moderate or severe prosthetic valve regurgitation). Severe prosthesis-patient mismatch is defined as an indexed effective orifice area (EOAi) ≤0.65 cm²/m² (≤0.55 cm²/m² if BMI ≥30 kg/m²).
- Safety endpoint at 1 year defined by the composite of all-cause death, disabling stroke, rehospitalization for heart failure, or valve-related problems.
- Secondary objective is comparison of the safety and efficacy of the SAPIEN versus MYVAL THV series, including the incidence of moderate or severe prosthesis-patient mismatch.
The continued-enrollment cohort is designed to support this comparison.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EVOLUT R/PRO/PRO+/FX bioprosthesis | Experimental | Device: EVOLUT R/PRO/PRO+/FX bioprosthesisStudy subjects will receive a self-expanding valve from the EVOLUT THV series (EVOLUT R/PRO/PRO+/FX). |
| SAPIEN 3/Ultra or MYVAL/Octacor/Octapro bioprosthesis | Active comparator | Device: Edwards Sapien S3/Ultra bioprosthesis, Device: MYVAL/Octacor/Octapro bioprosthesisStudy subjects will receive a balloon-expandable valve from either the SAPIEN THV series (SAPIEN 3, SAPIEN 3 Ultra) or the MYVAL THV series (Myval Octacor, Myval Octapro). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Failing surgical aortic bioprosthesis requiring valve replacement and eligible for transfemoral TAVI with balloon expandable or self-expanding platform per heart team consensus based on multi-modality imaging assessment (including echocardiography and multidetector CT).
- Written informed consent
Key exclusion criteria (6 listed)
- Not eligible for Transfemoral TAVI with EVOLUT, SAPIEN or MYVAL THV series
- Multi-valve defects requiring intervention
- Clinically unstable and/or inotropic/vasopressor /mechanical support.
- Known mural thrombus in the left ventricle
- Presence of a mechanical aortic valve
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 |
|---|---|---|
| EVOLUT R/PRO/PRO+/FX bioprosthesisTo compare EVOLUT R/PRO/PRO+/FX bioprosthesis versus Edwards SAPIEN 3/Ultra bioprosthesis or Myval/Octacor/ Octapro in failing surgical bioprostheses | Device | EVOLUT R/PRO/PRO+/FX bioprosthesis |
| Edwards Sapien S3/Ultra bioprosthesisEdwards Sapien S3/Ultra bioprosthesis | Device | SAPIEN 3/Ultra or MYVAL/Octacor/Octapro bioprosthesis |
| MYVAL/Octacor/Octapro bioprosthesisMYVAL/Octacor/Octapro bioprosthesis | Device | SAPIEN 3/Ultra or MYVAL/Octacor/Octapro bioprosthesis |
Primary outcome
Device success
Time frame: 30 days post transcatheter valve implantation
Defined by: * Absence of procedural mortality; AND * Technical success at exit from the procedure room defined as freedom from mortality, successful access, delivery of the device and retrieval of the delivery system, correct positioning of a single prosthetic heart valve into the proper anatomical location, and freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication; AND * Intended performance of the prosthetic heart valve (no severe prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s, Doppler velocity index ≥0.25, and no moderate or severe prosthetic valve regurgitation). Severe prosthesis-patient mismatch is defined as an indexed effective orifice area (EOAi) ≤0.65 cm²/m² (≤0.55 cm²/m² if BMI ≥30 kg/m²).
2 secondary outcomes
Composite of all-cause death, disabling stroke, rehospitalization for heart failure or valve related problems
Time frame: 1 year post transcatheter valve implantation
Moderate or severe prosthesis-patient mismatch
Time frame: 30 days post transcatheter valve implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Derived from this study: PubMed 36410441Nuis RJ, van Belle E, Teles R, Blackman D, Veulemans V, Santos IA, Pilgrim T, Tarantini G, Saia F, Iakovou I, Mascherbauer J, Vincent F, Geleijnse M, Sathananthan J, Wood D, Makkar R, Van Mieghem NM; BASELINE Investigators. BAlloon expandable vs. SElf expanding transcatheter vaLve for degenerated bioprosthesIs: design and rationale of the BASELINE trial. Am Heart J. 2023 Feb;256:139-147. doi: 10.1016/j.ahj.2022.11.013. Epub 2022 Nov 19.
- 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.
Nicolas Van Mieghem, MD, PhD principal investigator
Erasmus Medical Centre
Rutger-Jan Nuis, MD, PhD principal investigator
Erasmus Medical Centre
14 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EVOLUT R/PRO/PRO+/FX bioprosthesis, Edwards Sapien S3/Ultra bioprosthesis and MYVAL/Octacor/Octapro bioprosthesis in people with Valve Heart Disease, run by Erasmus Medical Center at 14 sites in 12 countries.
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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 13 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 14 sites in Germany, Italy, United States, Austria, Canada and 7 more countries. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rutger-Jan Nuis, MD, PhD (+31614858291, r.nuis@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device success (time frame: 30 days post transcatheter valve implantation). 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 NCT04843072, 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 13 Oct 2026.