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NCT Number: NCT05601453

The ReTAVI Prospective Observational Registry

Patients with severe aortic stenosis (sAS) treated with transcatheter aortic valve implantation (TAVI) (increasingly younger & lower risk pts) are experiencing SVD of the index THV and thus developing an indication for a redo-TAVI procedure.

The evidence on redo-TAVI (where a transcatheter heart valve [THV] is implanted into another THV) is limited, with initial data showing acceptable safety as well efficacy in highly selected and limited populations.

Aim is to evaluate short- and long-term data on patients undergoing transcatheter redo-TAVI procedures with THVs for failure of a previously implanted THV and to determine VARC-3 defined efficacy and safety at 30 days and functional outcome at 1 year, 3 years and 5 years.

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Key information

Conditions

Structural Valve Deterioration Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Prosthesis Failure Prosthetic Valve Malfunction Structural Valve Degeneration Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

LKH-University Hospital and Medical University of Graz, Graz, Austria

Loading trial locations.

About this study

Between 1.4 and 2.8% of all patients undergoing transcatheter heart valve (THV) implantation require a second THV implanted into the previously implanted THV because of clinically significant aortic regurgitation [1-3]. 90% of THV-in-THV implants were considered successful although the mortality in the redo-TAVI group was higher at similar STS risks as in those with a successful first implant.

Redo-TAVI may also be a promising treatment strategy in degenerated THVs, but there is insufficient knowledge which strategy and valve design may result in the best outcomes [4]. Evidence so far reported is based on case reports and small case series, but not on a prospective, multicenter documentation.

Currently, ~ 5% of THV are implanted in degenerated surgical bioprosthetic valves. With the expanded use of THV for treatment of lower risk patients with severe aortic stenosis (sAS), it is estimated that the number of patients requiring re-treatment for THV failure is likely to rise within the next years.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Consecutive patients fulfilling the following criteria:

  • Consenting adult patient (≥18 years)
  • Procedural success of the first TAVI
  • TAVI device failure of the index THV, irrespective of SVD severity
  • Intention to treat the patient with a redo-TAVI procedure (SAPIEN family THV)
  • The Local Heart Team and the Case Review Board consider the patient suitable and indicated for elective redo-TAVI
  • Patient is scheduled to undergo a 30 Day and 12 Months follow-up (both visits taking place in the hospital)

Exclusion criteria

  • Patients without signed informed consent / data protection statement (according to requirements of local IRB/IEC)
  • Life expectancy below 12 months
  • Patients with largely incomplete data with respect to the aims of the project
  • Pregnant women at the time of the redo-TAVI

Note: For all patients included a defined core data set will be collected prospectively. All patients being in accordance with above stated inclusion and exclusion criteria and receiving a balloon-expandable transcatheter aortic valve will be included in the extended documentation.

Treatment and study plan

Elective redo transcatheter aortic valve implantation (redo-TAVI)

Procedure

Elective redo-TAVI procedure with the intention to treat the patient with a SAPIEN family valve implantation (currently the only registered medical devices for redo-TAVI use)

Other names: redo-TAVI, redo-TAVR, Valve-in-Valve (ViV), TAV-in-TAV, TAVR-in-TAVR, Revalve

Primary outcomes

  1. Efficacy: VARC-3 defined device success at 30 days

    Time frame: 30 days

    Determine VARC-3 defined device success at 30 days

    • Technical success
    • Freedom from mortality
    • Freedom from surgery or intervention related to the device or a major vascular or access-related or cardiac structural complication
    • Intended performance of the valve (mean gradient <20 mmHg, peak velocity <3 m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation)

    (Different definitions, in addition to the predefined such as the consideration of higher gradients than 20 mmHg, will be explored)

    These events will be adjudicated. Number and percentage of subjects with device success at 30 days as per VARC-3 definition, along with individual component of the success, will be presented.

  2. Technical success: Technical success (at exit from procedure room)

    Time frame: end of intervention

    Technical success at exit from 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
    • Freedom from surgery or intervention related to the device (excluding pacemaker) or to a major vascular or access-related, or cardiac structural complication

    Number and percentage of subjects with technical success at exit from procedure room, along with individual component of the success, will be presented.

  3. Safety: VARC-3 defined early safety at 30 days

    Time frame: 30 days

    Determine VARC-3 defined early safety at 30 days:

    • Freedom from all-cause mortality
    • Freedom from all Stroke
    • Freedom from all VARC type 2-4 bleeding
    • Freedom from all major vascular, access-related, or cardiac structural complication
    • Freedom from all acute kidney injury stage III/IV
    • Freedom from all moderate/severe aortic regurgitation
    • Freedom from all new permanent pacemaker implantations due to procedure-related conduction abnormalities
    • Freedom from all surgery/intervention related to the device

    These events will be adjudicated. Number and percentage of subjects with early safety at 30 days as per VARC-3 definition, along with individual component of the success, will be presented.

  4. Procedural Outcomes (30 days)

    Time frame: 30 days

    Procedural outcomes at 30 days, defined as:

    • Clinical and anatomical predictors of technical success (type of SVD [stenosis vs. regurgitation], valve size, implant depth, redo-TAVI balloon dilation, CT and echo-derived variables, etc.)
    • Rate of central and paravalvular regurgitation
    • Valve performance, including residual mean gradient
    • Risk and predictors of coronary obstruction

    Number and percentage of subjects with above specified outcomes at 30 days , along with individual component of the success, will be presented.

  5. Durability of the second aortic THV (30 days)

    Time frame: 30 days

    Determine the durability of the second aortic THV:

    • Subclinical transcatheter heart valve thrombosis at thirty days (when it becomes apparent, but no systematic screening)
    • Endocarditis

    Definition of transcatheter heart valve thrombosis Clinical sequelae of a thromboembolic event (e.g. stroke, TIA, retinal occlusion, other evidence of systemic thromboembolism) or worsening valve stenosis/ regurgitation (e.g. signs of heart failure, syncope) and

    • Haemodynamic valve deterioration Stage 2 or 3 or
    • Confirmatory imaging (CT evidence of HALT† or TEE findings) In the absence of clinical sequelae, both
    • Haemodynamic valve deterioration Stage 3 and
    • Confirmatory imaging (CT evidence of HALT or TEE findings)

    Number and percentage of subjects with above specified criteria at 3 months, along with individual component of the success, will be presented.

  6. Durability of the second aortic THV (3 months)

    Time frame: 3 months

    Determine the durability of the second aortic THV:

    • Subclinical transcatheter heart valve thrombosis at three months (if data obtained, when it becomes apparent, but no systematic screening)
    • Clinical transcatheter heart valve thrombosis at three months (if data obtained)
    • Endocarditis

    For the definition of transcatheter cardiac valve thrombosis, please refer to Outcome 5.

    Number and percentage of subjects with above specified criteria at 3 months, along with individual component of the success, will be presented.

  7. Durability of the second aortic THV (12 months)

    Time frame: 12 months

    Determine the durability of the second aortic THV:

    • Subclinical transcatheter heart valve thrombosis at twelve months (when it becomes apparent, but no systematic screening)
    • Clinical transcatheter heart valve thrombosis at twelve months
    • All-cause mortality, stroke, myocardial infarction, and cardiovascular hospitalization at twelve months
    • Stage II or III structural valve degeneration according to VARC 3 definitions at twelve months (stage I may be documented)
    • Endocarditis

    For the definition of transcatheter cardiac valve thrombosis, please refer to Outcome 5. Number and percentage of subjects with above specified criteria at 12 months , along with individual component of the success, will be presented.

  8. Durability of the second aortic THV (3 years)

    Time frame: 3 years

    Determine the durability of the second aortic THV:

    • Subclinical transcatheter heart valve thrombosis at 3 years (when it becomes apparent, but no systematic screening)
    • Clinical transcatheter heart valve thrombosis at 3 years
    • All-cause mortality, stroke, myocardial infarction, and cardiovascular hospitalization at 3 years

    For the definition of transcatheter cardiac valve thrombosis, please refer to Outcome 5.

  9. Durability of the second aortic THV (5 years)

    Time frame: 5 years

    Determine the durability of the second aortic THV:

    • Subclinical transcatheter heart valve thrombosis at 5 years (when it becomes apparent, but no systematic screening)
    • Clinical transcatheter heart valve thrombosis at 5 years
    • All-cause mortality, stroke, myocardial infarction, and cardiovascular hospitalization at 5 years

    For the definition of transcatheter cardiac valve thrombosis, please refer to Outcome 5.

Other outcomes

  1. Compliance with recommendation

    Time frame: 12 months

    It will be assessed and percentages determined whether participating centers follow the published recommendation (itemized, compliance being voluntary).

  2. Impact of alterations to published recommendations

    Time frame: 12 months

    The impact of potential alterations to the protocol on the procedural outcomes will be elucidated and descriptively described.

  3. Discretionary longer-term follow-up

    Time frame: up to 5 years

    Discretionary longer-term follow-up in terms of durability of the second aortic THV:

    • Subclinical transcatheter heart valve thrombosis
    • Clinically symptomatic transcatheter heart valve thrombosis
    • All-cause mortality, stroke, and cardiovascular hospitalization
    • Stage II or III structural valve degeneration according to VARC 3 definitions

    For the definition of transcatheter cardiac valve thrombosis, please refer to Outcome 5.

    Number and percentage of subjects with above specified criteria with up to 5 years follow-up, along with individual component of the success, will be presented.

  4. Exploratory objectives

    Time frame: 12 months

    Further, not predefined research questions will be explored based on the dataset such as:

    • Hemodynamic outcome of the intervention
    • Applicability of VARC-3 criteria for the redo-TAVI situation
    • Coronary artery obstruction due to valve implantation
    • Coronary artery cannulation (in particular in case of risk plane above ostia)
    • Early and late THV failure predictors (after TAVI and redo-TAVI procedures)
    • CT findings related to THV failure (SVD)

Study contacts

Contact information is provided by the study sponsor or research team.

Claudia Lüske, PhD

CONTACT

[email protected]

044718503324 ext. +49

Daniel Greinert

CONTACT

[email protected]

044718503328 ext. +49

Sponsors and collaborators

Lead sponsor

Institut für Pharmakologie und Präventive Medizin

Network

Collaborators

  • Edwards Lifesciences

Registry information

Official study title

Evaluation of Clinical Outcomes of Patients Undergoing a Redo-TAVI Procedure; a Multicenter Prospective Observational Registry

Important dates

Study start
2023
Primary completion
2026
Study completion
2031
First posted
Nov 1, 2022
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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