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Active, not recruitingNCT03520101Updated Nov 5, 2026

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

An interventional study of TAVI_ViV procedure with Edwards valve and TAVI_ViV procedure with CoreValve system in Aortic Valve Stenosis, Regurgitation, Aortic and Prosthesis Failure, sponsored by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec. Active, not recruiting at 1 site in Canada. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec · Not applicable, Interventional, and Treatment

Updated Nov 5, 2026Primary outcomes revisedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Randomized
Sex
All
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Study 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 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.

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Conditions studied

  • Aortic Valve Stenosis
  • Regurgitation, Aortic
  • Prosthesis Failure
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In context

Aortic Valve Stenosis

1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.

This study's enrollment of 102 is below the median of 126 across 554 interventional studies indexed under Aortic Valve Stenosis.

Browse Aortic Valve Stenosis studies →

Lead sponsor

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec is the lead sponsor of 23 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

- Stentless or sutureless surgical valves

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
102 participants (actual)

Study arms

  • Other
    SAPIEN

    Following the Heart Team's decision to proceed with a TAVI-ViV procedure, patients will received an Edwards (SAPIEN XT or SAPIEN 3) valve.

    Procedure: TAVI_ViV procedure with Edwards valve

  • Other
    COREVALVE

    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.

    Procedure: TAVI_ViV procedure with CoreValve system

Interventions

  • ProcedureTAVI_ViV procedure with Edwards valve

    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.

  • ProcedureTAVI_ViV procedure with CoreValve system

    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.

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What researchers measure

Primary outcomes

  1. 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).

    Time frame: 30 days

  2. 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.

    Time frame: 30 days

Secondary outcomes

  1. Transvalvular gradient.

    Maximal and mean transvalvular gradient

    Time frame: 1-year and yearly thereafter up to 10-year follow-up

  2. Valve performance : Moderate or severe PPM moderate-severe AR at 30 days and 1 year.

    Moderate or severe PPM; moderate-severe AR.

    Time frame: 30 days, 1 year and yearly thereafter up to 10-year follow-up

  3. Combined endpoints: Moderate-severe AR or severe PPM at 1-year follow-up.

    Moderate-severe AR or severe PPM.

    Time frame: 1 year and yearly thereafter up to 10-year follow-up

  4. Clinical safety endpoints

    individually and combined: death, stroke, major or life threatening bleeding, pacemaker implantation, myocardial infarction.

    Time frame: 30 days, 1 year and yearly thereafter up to 10-year follow-up

  5. Exercise capacity

    Exercise capacity as evaluated by the six-minute walk test

    Time frame: 30 days, 1 year and yearly thereafter up to 10-year follow-up

  6. Changes in LV hypertrophy

    Changes in LV hypertrophy

    Time frame: 30 days , 1 year and yearly thereafter up to 10-year follow-up

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Study locations

1 site
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References and documents

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 ↗
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Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2017 to primary completion in Feb 2022, 57 months.

Of 177 non-industry interventional studies with no phase under Aortic Valve Stenosis, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 79. This study's 57 months is above that.

Counting every sponsor, half of 288 studies reached it within 33 months; a quarter within 18 and three quarters within 72.

How these figures are worked out, and which studies are left out of them.

Registered
May 8, 2017
First posted
May 9, 2018
StartActual
May 10, 2017
Primary completionActual
Feb 22, 2022
CompletionEst.
May 31, 2030
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary outcomes
1 description edited
What changed in the outcomes
  • DescriptionResidual transvalvular gradient: how it is measured was reworded
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    Primary outcomes 1 description edited
    What changed in the outcomes
    • DescriptionResidual transvalvular gradient: how it is measured was reworded

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT03520101
Lead sponsor
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Responsible party
Josep Rodes-Cabau (Principal investigator, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec) — Principal investigator
First posted
May 9, 2018
Start date
May 10, 2017
Primary completion
Feb 22, 2022
Completion
May 31, 2030 (estimated)
Last update
Nov 5, 2026

Study contacts

Josep Rodés-Cabau, MD
principal investigator · Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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