Evaluation of the Viability and Safety of Early Discharge Protocol After TAVI Implantation (FAST TRACK)

December 15, 2025 updated by: Fundación EPIC
Evaluation of the safety and efficacy of early discharge (24 hours) after transfemoral transcatheter aortic prosthesis implantation (TAVI).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
585

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Spain
      • A Coruña, Spain, 15006
        • Hospital Universitario A Coruña
      • Alicante, Spain, 03010
        • Hospital General Universitario Dr. Balmis
      • Aravaca, Spain, 28040
        • Hospital Clinico San Carlos
      • Badalona, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall Hebron
      • Barcelona, Spain, 08025
        • Hospital de Santa Creu I Sant Pau
      • L'Hospitalet de Llobregat, Spain, 08907
        • Hospital Universitario de Bellvitge
      • Málaga, Spain, 29010
        • Hospital Regional Universitario de Malaga
      • Oviedo, Spain, 33011
        • Hospital Universitario Central de Asturias
      • Pamplona, Spain, 31008
        • Hospital Universitario de Navarra
      • Santiago de Compostela, Spain, 15706
        • Hospital Clinico Universitario de Santiago
      • Seville, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Valencia, Spain, 46026
        • Hospital Universitari I Politècnic La Fe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Patients undergoing scheduled transfemoral TAVI implantation, performed on an outpatient basis

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients receiving transfemoral (TF) TAVI
TF TAVI
Device: TF TAVI
Follow-up Observation of patients having received a TF-TAVI

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of Cardiovascular death
Time Frame: 30 days
Assessment of Cardiovascular death
30 days
Assessment of Cardiovascular death
Time Frame: 12 months
Assessment of Cardiovascular death
12 months
Assessment of Stroke
Time Frame: 30 days
Incidence of patients with stroke diagnosed by a Neurologist according to VARC 3 criteria
30 days
Assessment of Stroke
Time Frame: 12 months
Incidence of patients with stroke diagnosed by a Neurologist according to VARC 3 criteria
12 months
Assessment of Myocardial Infarction
Time Frame: 30 days
Incidence of patients with Myocardial Infarction diagnosed by Cardiologist according to VARC 3 criteria
30 days
Assessment of Myocardial Infarction
Time Frame: 12 months
Incidence of patients with Myocardial Infarction diagnosed by Cardiologist according to VARC 3 criteria
12 months
Assessment of Hospitalization for any reason
Time Frame: 30 days
Incidence of patients with Hospitalization for any reason according to VARC 3 criteria
30 days
Assessment of Hospitalization for any reason
Time Frame: 12 months
Incidence of patients with Hospitalization for any reason according to VARC 3 criteria
12 months
Assessments of Major Vascular Complications
Time Frame: 30 days
Incidence of patients with Major Vascular Complications according to VARC 3 criteria
30 days
Assessments of Major Vascular Complications
Time Frame: 12 months
Incidence of patients with Major Vascular Complications according to VARC 3 criteria
12 months
Assessments of need for pacemakers
Time Frame: 30 days
Incidence of patients with need for pacemakers according to VARC 3 criteria
30 days
Assessments of need for pacemakers
Time Frame: 12 months
Incidence of patients with need for pacemakers according to VARC 3 criteria
12 months
Assessment of hospitalization time
Time Frame: at discharge
Incidence of patients with hospitalization according to VARC 3 criteria
at discharge
Assessment of hospitalization due cardiac reasons
Time Frame: 12 months
Incidence of patients with hospitalization due cardiac reasons according to VARC 3 criteria
12 months
Assessment of hospitalization due cardiac reasons
Time Frame: 30 days
Incidence of patients with hospitalization due cardiac reasons according to VARC 3 criteria
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundación EPIC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 4, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EPIC19-FAST TRACK

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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