Aortic Valve StenosisNCT03520101

Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprotheses. The 'LYTEN' Trial

A study testing TAVI_ViV procedure with Edwards valve and TAVI_ViV procedure with CoreValve system in people with Aortic Valve Stenosis and Regurgitation, Aortic, run by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

The treatment with transcatheter aortic valve implantation (TAVI) of patients with small (≤23mm) surgical bioprostheses remains a challenge due to the increased transvalvular residual gradients and high rates of severe prosthesis-patient mismatch (PPM) following the procedure. Read more about this study

Who is it for?: Any age
Conditions the study is for: Aortic Valve Stenosis, Regurgitation, Aortic, Prosthesis Failure
What is being tested?: TAVI_ViV procedure with Edwards valve and TAVI_ViV procedure with CoreValve system
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 102 participants
Where: 1 siteCanada
Study dates: 10 May 2017to 31 May 2030
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Patients with surgical aortic bioprosthetic dysfunction defined as severe aortic stenosis and/or regurgitation approved for a ViV procedure by the Heart Team
Stented surgical valves.
Small (≤23mm) surgical valve

Who cannot join

Stentless or sutureless surgical valves

Trial locations and contacts

1 site in 1 country.

Canada1 site

IUCPQ
Québec, Quebec, G1V 4G5

Other trials in Canada

About this study

Official title: Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprotheses: A Pilot Prospective Randomized Trial. The 'LYTEN' Trial

Read the detailed description

This is a prospective, multicenter, randomized open-label trial including patients with surgical aortic bioprosthetic dysfunction in the presence of a small (≤23mm; inner diameter ≤21 mm) stented surgical valve. Following the Heart Team'S decision to proceed with a TAVI-ViV procedure, patients will be randomized to either receive an Edwards (SAPIEN XT or SAPIEN 3) valve or a CoreValve Evolut R or Evolut PRO system. New iterations of these valve models may also be included.

Conditions: Aortic Valve Stenosis, Regurgitation, Aortic, Prosthesis Failure
Being tested: TAVI_ViV procedure with Edwards valve, TAVI_ViV procedure with CoreValve system
Medical subject headings: Aortic Valve Stenosis, Aortic Valve Insufficiency, Prosthesis Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TAVI_ViV procedure with Edwards valveProcedure or surgery
The TAVR procedure will be performed following the standards of each participating center. No restriction or specific recommendation will be given regarding the approach, general vs. local anesthesia, imaging guidance during the TAVI procedure, and post-procedural TAVI management. The decision for selecting either a 20 or 23mm Edwards valve will be based on 3D CT measurements of the mean inner diameter of the surgical aortic bioprosthesis. A 23mm Sapien 3 valve will be recommended if the inner diameter is >18 mm, and a 20mm valve will be selected if the mean inner diameter is ≤18 mm.
TAVI_ViV procedure with CoreValve systemProcedure or surgery
The TAVR procedure will be performed following the standards of each participating center. No restriction or specific recommendation will be given regarding the approach, general vs. local anesthesia, imaging guidance during the TAVI procedure, and post-procedural TAVI management. A 23mm valve will be recommended in all patients randomized to the self-expanding CoreValve Evolut R system.

Study groups in NCT03520101
Study group	Role	What they receive
SAPIEN	Other	Following the Heart Team's decision to proceed with a TAVI-ViV procedure, patients will received an Edwards (SAPIEN XT or SAPIEN 3) valve. Receives: Procedure: TAVI_ViV procedure with Edwards valve
COREVALVE	Other	Following the Heart Team's decision to proceed with a TAVI-ViV procedure, patients will received the CoreValve Evolut R or Evolut PRO valve system. Receives: Procedure: TAVI_ViV procedure with CoreValve system

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate of prothesis-patient mismatch (PPM) (valve performance)
Severe prothesis-patient mismatch (PPM) (defined as an index aortic valve area ≤0.65 cm2/m2) and/or moderate-severe aortic regurgitation (AR) (VARC-2 definition).
Measured: 30 days
Residual transvalvular gradient
Residual transvalvular gradient will be assessed by transthoracic echocardiography (TTE) using Doppler echocardiographic measurements. The mean and maximal transvalvular pressure gradients (mmHg) will be recorded.
Measured: 30 days

Secondary outcomes (6)

Transvalvular gradient.
Maximal and mean transvalvular gradient
Measured: 1-year and yearly thereafter up to 10-year follow-up
Valve performance : Moderate or severe PPM moderate-severe AR at 30 days and 1 year.
Moderate or severe PPM; moderate-severe AR.
Measured: 30 days, 1 year and yearly thereafter up to 10-year follow-up
Combined endpoints: Moderate-severe AR or severe PPM at 1-year follow-up.
Moderate-severe AR or severe PPM.
Measured: 1 year and yearly thereafter up to 10-year follow-up
Clinical safety endpoints
individually and combined: death, stroke, major or life threatening bleeding, pacemaker implantation, myocardial infarction.
Measured: 30 days, 1 year and yearly thereafter up to 10-year follow-up
Exercise capacity
Exercise capacity as evaluated by the six-minute walk test
Measured: 30 days, 1 year and yearly thereafter up to 10-year follow-up
Changes in LV hypertrophy
Changes in LV hypertrophy
Measured: 30 days , 1 year and yearly thereafter up to 10-year follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 May 201731 May 2030

First posted9 May 2018
Study start10 May 2017
Primary completion22 Feb 2022
Study completion31 May 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Aortic Valve StenosisStudies 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
Model description: Prospective, multicenter, randomized trial including patients with surgical aortic bioprosthetic dysfunction in the presence of a small stented surgical valve. Patients will be randomized to either receive an Edwards (SAPIEN XT or SAPIEN 3) valve or a Core Valve Evolut R or Evolut PRO system.
Masking: None (open label)
Enrolment: 102 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03520101
Sponsor's protocol ID: LYTEN
Status last verified: Mar 2026
First submitted: 8 May 2017
Last updated: 5 Nov 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Cepas-Guillen P, Abbas AE, Serra V, Vilalta V, Nombela-Franco L, Regueiro A, Al-Azizi KM, Iskander A, Conradi L, Forcillo J, Lilly S, Calabuig A, Fernandez-Nofrerias E, Mohammadi S, Giuliani C, Pelletier-Beaumont E, Pibarot P, Rodes-Cabau J. Balloon- Versus Self-Expanding Transcatheter Valves for Failed Small Surgical Aortic Bioprostheses: 3-Year Results of the LYTEN Trial. Circ Cardiovasc Interv. 2026 Mar;19(3):e016255. doi: 10.1161/CIRCINTERVENTIONS.125.016255. Epub 2026 Feb 2.
PubMed 41623058
Nuche J, Abbas AE, Serra V, Vilalta V, Nombela-Franco L, Regueiro A, Al-Azizi KM, Iskander A, Conradi L, Forcillo J, Lilly S, Calabuig A, Fernandez-Nofrerias E, Mohammadi S, Giuliani C, Pelletier-Beaumont E, Pibarot P, Rodes-Cabau J. Balloon- vs Self-Expanding Transcatheter Valves for Failed Small Surgical Aortic Bioprostheses: 1-Year Results of the LYTEN Trial. JACC Cardiovasc Interv. 2023 Dec 25;16(24):2999-3012. doi: 10.1016/j.jcin.2023.10.028. Epub 2023 Oct 23.
PubMed 37902146
Rodes-Cabau J, Abbas AE, Serra V, Vilalta V, Nombela-Franco L, Regueiro A, Al-Azizi KM, Iskander A, Conradi L, Forcillo J, Lilly S, Calabuig A, Fernandez-Nofrerias E, Mohammadi S, Panagides V, Pelletier-Beaumont E, Pibarot P. Balloon- vs Self-Expanding Valve Systems for Failed Small Surgical Aortic Valve Bioprostheses. J Am Coll Cardiol. 2022 Aug 16;80(7):681-693. doi: 10.1016/j.jacc.2022.05.005. Epub 2022 May 18.
PubMed 35597385

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Acute Pain
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NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
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Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
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All Aortic Valve Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprotheses: A Pilot Prospective Randomized Trial. The 'LYTEN' Trial
ClinicalTrials.gov ID: NCT03520101
Acronym / sponsor ID: LYTEN
Conditions: Aortic Valve Stenosis, Regurgitation, Aortic, Prosthesis Failure
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 102 participants (actual)
Lead sponsor: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de QuebecUniversity, hospital or other
Study start: 10 May 2017 (actual)
Primary completion: 22 Feb 2022 (actual)
Study completion: 31 May 2030 (estimated)
First posted: 9 May 2018 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Prospective, multicenter, randomized trial including patients with surgical aortic bioprosthetic dysfunction in the presence of a small stented surgical valve. Patients will be randomized to either receive an Edwards (SAPIEN XT or SAPIEN 3) valve or a Core Valve Evolut R or Evolut PRO system.

Arm	Type	Receives
SAPIEN	Other	Procedure: TAVI_ViV procedure with Edwards valveFollowing the Heart Team's decision to proceed with a TAVI-ViV procedure, patients will received an Edwards (SAPIEN XT or SAPIEN 3) valve.
COREVALVE	Other	Procedure: TAVI_ViV procedure with CoreValve systemFollowing the Heart Team's decision to proceed with a TAVI-ViV procedure, patients will received the CoreValve Evolut R or Evolut PRO valve system.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Patients with surgical aortic bioprosthetic dysfunction defined as severe aortic stenosis and/or regurgitation approved for a ViV procedure by the Heart Team
Stented surgical valves.
Small (≤23mm) surgical valve

Key exclusion criteria (1 listed)

Stentless or sutureless surgical valves

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
TAVI_ViV procedure with Edwards valveThe TAVR procedure will be performed following the standards of each participating center. No restriction or specific recommendation will be given regarding the approach, general vs. local anesthesia, imaging guidance during the TAVI procedure, and post-procedural TAVI management. The decision for selecting either a 20 or 23mm Edwards valve will be based on 3D CT measurements of the mean inner diameter of the surgical aortic bioprosthesis. A 23mm Sapien 3 valve will be recommended if the inner diameter is >18 mm, and a 20mm valve will be selected if the mean inner diameter is ≤18 mm.	Procedure or surgery	SAPIEN
TAVI_ViV procedure with CoreValve systemThe TAVR procedure will be performed following the standards of each participating center. No restriction or specific recommendation will be given regarding the approach, general vs. local anesthesia, imaging guidance during the TAVI procedure, and post-procedural TAVI management. A 23mm valve will be recommended in all patients randomized to the self-expanding CoreValve Evolut R system.	Procedure or surgery	COREVALVE

Primary outcome

Rate of prothesis-patient mismatch (PPM) (valve performance)
Time frame: 30 days
Severe prothesis-patient mismatch (PPM) (defined as an index aortic valve area ≤0.65 cm2/m2) and/or moderate-severe aortic regurgitation (AR) (VARC-2 definition).
Residual transvalvular gradient
Time frame: 30 days
Residual transvalvular gradient will be assessed by transthoracic echocardiography (TTE) using Doppler echocardiographic measurements. The mean and maximal transvalvular pressure gradients (mmHg) will be recorded.

6 secondary outcomes

Transvalvular gradient.
Time frame: 1-year and yearly thereafter up to 10-year follow-up
Valve performance : Moderate or severe PPM moderate-severe AR at 30 days and 1 year.
Time frame: 30 days, 1 year and yearly thereafter up to 10-year follow-up
Combined endpoints: Moderate-severe AR or severe PPM at 1-year follow-up.
Time frame: 1 year and yearly thereafter up to 10-year follow-up
Clinical safety endpoints
Time frame: 30 days, 1 year and yearly thereafter up to 10-year follow-up
Exercise capacity
Time frame: 30 days, 1 year and yearly thereafter up to 10-year follow-up
Changes in LV hypertrophy
Time frame: 30 days , 1 year and yearly thereafter up to 10-year follow-up

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 5 Nov 2026.
Derived from this study: PubMed 41623058Cepas-Guillen P, Abbas AE, Serra V, Vilalta V, Nombela-Franco L, Regueiro A, Al-Azizi KM, Iskander A, Conradi L, Forcillo J, Lilly S, Calabuig A, Fernandez-Nofrerias E, Mohammadi S, Giuliani C, Pelletier-Beaumont E, Pibarot P, Rodes-Cabau J. Balloon- Versus Self-Expanding Transcatheter Valves for Failed Small Surgical Aortic Bioprostheses: 3-Year Results of the LYTEN Trial. Circ Cardiovasc Interv. 2026 Mar;19(3):e016255. doi: 10.1161/CIRCINTERVENTIONS.125.016255. Epub 2026 Feb 2.
Derived from this study: PubMed 37902146Nuche J, Abbas AE, Serra V, Vilalta V, Nombela-Franco L, Regueiro A, Al-Azizi KM, Iskander A, Conradi L, Forcillo J, Lilly S, Calabuig A, Fernandez-Nofrerias E, Mohammadi S, Giuliani C, Pelletier-Beaumont E, Pibarot P, Rodes-Cabau J. Balloon- vs Self-Expanding Transcatheter Valves for Failed Small Surgical Aortic Bioprostheses: 1-Year Results of the LYTEN Trial. JACC Cardiovasc Interv. 2023 Dec 25;16(24):2999-3012. doi: 10.1016/j.jcin.2023.10.028. Epub 2023 Oct 23.
Derived from this study: PubMed 35597385Rodes-Cabau J, Abbas AE, Serra V, Vilalta V, Nombela-Franco L, Regueiro A, Al-Azizi KM, Iskander A, Conradi L, Forcillo J, Lilly S, Calabuig A, Fernandez-Nofrerias E, Mohammadi S, Panagides V, Pelletier-Beaumont E, Pibarot P. Balloon- vs Self-Expanding Valve Systems for Failed Small Surgical Aortic Valve Bioprostheses. J Am Coll Cardiol. 2022 Aug 16;80(7):681-693. doi: 10.1016/j.jacc.2022.05.005. Epub 2022 May 18.

Related trials for Aortic Valve Stenosis

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Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
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Recruiting
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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.

Josep Rodés-Cabau, MD principal investigator

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 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: under way, not looking for participants, as of the sponsor's last update on 5 Nov 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 Canada. 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?

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 prothesis-patient mismatch (PPM) (valve performance) (time frame: 30 days). 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 NCT03520101, which also lists 3 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 5 Nov 2026.