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NCT Number: NCT05758909

Evaluation of the Viability and Safety of Early Discharge Protocol After TAVI Implantation

Evaluation of the safety and efficacy of early discharge (24 hours) after transfemoral transcatheter aortic prosthesis implantation (TAVI).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario A Coruña, A Coruña, Spain

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About this study

Evaluation of the safety and efficacy of early discharge (24 hours) after transfemoral transcatheter aortic prosthesis implantation (TAVI).

Who can participate

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

Inclusion criteria

Patients who meet all of the following conditions will be included:

  • Patients ≥ 18 years undergoing transfemoral TAVI implantation scheduled, performed on an outpatient basis.
  • Patients with percutaneous implant.
  • Patients undergoing the procedure under superficial sedation or Local anesthesia.
  • Patients with baseline narrow QRS that does not change after implantation, or definitive pacemaker carrier.
  • Patients who have signed the informed consent.

Exclusion criteria

Patients who do not meet any of the following conditions:

  • Patients with a wide QRS (greater than or equal to 120 msec) at baseline, with the except for patients with permanent pacemakers.
  • Hospitalized patients undergoing urgent TAVI implantation.
  • Patients with access other than percutaneous transfemoral.

Treatment and study plan

TF TAVI

Device

Follow-up Observation of patients having received a TF-TAVI

Primary outcomes

  1. Assessment of early safety

    Time frame: 30 days

    Proportion of patients with early safety defined as:

    • Cardiovascular death.
    • Stroke.
    • Myocardial Infarction.
    • Hospitalization for any reason .
    • Major vascular complications.
    • Need for pacemakers.

Secondary outcomes

  1. Assessment of Cardiovascular death

    Time frame: 30 days

    Assessment of Cardiovascular death

  2. Assessment of Cardiovascular death

    Time frame: 12 months

    Assessment of Cardiovascular death

  3. Assessment of Stroke

    Time frame: 30 days

    Incidence of patients with stroke diagnosed by a Neurologist according to VARC 3 criteria

  4. Assessment of Stroke

    Time frame: 12 months

    Incidence of patients with stroke diagnosed by a Neurologist according to VARC 3 criteria

  5. Assessment of Myocardial Infarction

    Time frame: 30 days

    Incidence of patients with Myocardial Infarction diagnosed by Cardiologist according to VARC 3 criteria

  6. Assessment of Myocardial Infarction

    Time frame: 12 months

    Incidence of patients with Myocardial Infarction diagnosed by Cardiologist according to VARC 3 criteria

  7. Assessment of Hospitalization for any reason

    Time frame: 30 days

    Incidence of patients with Hospitalization for any reason according to VARC 3 criteria

  8. Assessment of Hospitalization for any reason

    Time frame: 12 months

    Incidence of patients with Hospitalization for any reason according to VARC 3 criteria

  9. Assessments of Major Vascular Complications

    Time frame: 30 days

    Incidence of patients with Major Vascular Complications according to VARC 3 criteria

  10. Assessments of Major Vascular Complications

    Time frame: 12 months

    Incidence of patients with Major Vascular Complications according to VARC 3 criteria

  11. Assessments of need for pacemakers

    Time frame: 30 days

    Incidence of patients with need for pacemakers according to VARC 3 criteria

  12. Assessments of need for pacemakers

    Time frame: 12 months

    Incidence of patients with need for pacemakers according to VARC 3 criteria

  13. Assessment of hospitalization time

    Time frame: at discharge

    Incidence of patients with hospitalization according to VARC 3 criteria

  14. Assessment of hospitalization due cardiac reasons

    Time frame: 12 months

    Incidence of patients with hospitalization due cardiac reasons according to VARC 3 criteria

  15. Assessment of hospitalization due cardiac reasons

    Time frame: 30 days

    Incidence of patients with hospitalization due cardiac reasons according to VARC 3 criteria

Sponsors and collaborators

Lead sponsor

Fundación EPIC

Other

Registry information

Acronym: FAST TRACK

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 8, 2023
Registry last updated
Dec 19, 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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