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Same-Day Versus Standard Hospital Discharge After TAVI (HOME-TAVI)

ConditionsAortic Stenosis, SevereAortic Stenosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Clinic of Barcelona

About this trial

Transcatheter aortic valve implantation (TAVI) has become the standard treatment for patients with severe aortic stenosis across a broad range of surgical risk. Advances in device technology and procedural techniques have enabled minimalist approaches and shorter hospital stays. Preliminary observational studies suggest that same-day discharge after TAVI may be feasible and safe in carefully selected patients, but randomized evidence remains limited, particularly in patients treated with self-expanding valves. The HOME-TAVI trial is a prospective, multicenter, international, randomized controlled trial designed to evaluate whether a same-day discharge strategy is non-inferior to standard hospital discharge after successful transfemoral TAVI with the Medtronic Evolut PRO+/FX/FX+ system. Eligible patients who remain clinically stable 6 hours after the procedure will be randomized in a 1:1 ratio to same-day discharge or standard-of-care discharge.

The primary endpoint is a composite of all-cause mortality, type 2-4 bleeding, stroke, and hospital readmission within 30 days after TAVI. Secondary objectives include assessment of quality of life, patient-reported experience measures, healthcare resource utilization, and cost-effectiveness.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults (≥18 years of age)

Severe symptomatic aortic stenosis scheduled for elective transfemoral TAVI

Treatment with the Medtronic Evolut PRO+, Evolut FX, Evolut FX+, or subsequent iterations

Successful TAVI procedure according to VARC-3 technical success criteria

Disqualifiers

Inability to ambulate independently at baseline

Hemodynamic or clinical instability before TAVI

Urgent or emergent TAVI procedure

Non-transfemoral access

Trial design

Design model

Parallel

Treatments tested in this trial

  • Same-Day Discharge Strategy

    Other intervention

    Participants are discharged on the same day following successful transfemoral TAVI after confirmation of clinical stability 6 hours after the procedure. The discharge pathway includes standardized clinical assessment, patient and caregiver education, pre-discharge transthoracic echocardiography and blood testing, and a follow-up telephone assessment on the day after discharge.

  • Standard-of-Care Discharge Strategy

    Other intervention

    Participants receive routine post-procedural inpatient care following successful transfemoral TAVI and are discharged according to standard clinical practice (next-day or later discharge), with follow-up assessments performed according to the study protocol.

Treatment groups

764 Participants
are divided into 2 treatment groups
Group A: Same-Day DischargeExperimental treatment 1 intervention
Group B: Standard-of-Care DischargeActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Composite of all-cause mortality, type 2-4 bleeding, stroke, and hospital readmission

Composite of all-cause mortality, type 2-4 bleeding, stroke, and hospital readmission, defined according to Valve Academic Research Consortium-3 (VARC-3) criteria

Time frame
from randomization (6 hours after TAVI) through 30 days after TAVI

Secondary outcomes

1

Change in health-related quality of life assessed using the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12)

Change in health-related quality of life measured using the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12). The KCCQ-12 is a disease-specific questionnaire assessing symptoms, physical limitations, social limitations, and quality of life in patients with heart disease. Scores range from 0 to 100, with higher scores indicating better health status and quality of life.

Time frame
Baseline and 30 days
2

Change in health-related quality of life assessed using the EuroQol-5 Dimensions 5 Levels (EQ-5D-5L)

Change in health-related quality of life measured using the EuroQol-5 Dimensions 5 Levels (EQ-5D-5L) questionnaire. The EQ-5D-5L descriptive system assesses five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with five response levels. Responses are converted into an EQ-5D-5L index value, with higher values indicating better health status. (If you are reporting the EQ Visual Analogue Scale instead of the index score, the description should instead state that the EQ VAS ranges from 0 to 100, with higher scores indicating better perceived health.)

Time frame
Baseline and 30 days
3

Readiness for Hospital Discharge

Patient-reported readiness for hospital discharge assessed using the Readiness for Hospital Discharge Scale (RHDS) before discharge. The RHDS score ranges from 0 to 10, with higher scores indicating greater readiness for hospital discharge.

Time frame
Pre-discharge
4

Post-discharge care delivery satisfaction

Patient-reported satisfaction with post-discharge care assessed using the Post-Discharge Care Delivery Satisfaction (PDCDS) questionnaire at 7 days after discharge. The PDCDS score ranges from \[minimum\] to \[maximum\], with higher scores indicating greater satisfaction with post-discharge care.

Time frame
7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Clinic of Barcelona

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: