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

NCT07738575 | Not Yet Recruiting

• 1 other identifier: HOME-TAVI 2026-4460
• Study Type: interventional
• Target: 764
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

Aortic Stenosis, Severe; Aortic Stenosis

Keywords

Transcatheter Aortic Valve Implantation (TAVI); TAVI; TAVR; Same-Day Discharge; Early Discharge; Self-Expanding Valve; Evolut FX; Evolut FX+; Evolut PRO+

Outcome Measures

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

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

Secondary Outcomes (20)

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

  Baseline and 30 days

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

  Baseline and 30 days

• Readiness for Hospital Discharge

  Pre-discharge

• Post-discharge care delivery satisfaction

  7 days

• Quality-adjusted life years (QALYs)

  1 year

Study Arms (2)

Same-Day Discharge

EXPERIMENTAL

Participants randomized to the experimental arm will undergo a predefined same-day discharge pathway following successful transfemoral TAVI with the Medtronic Evolut PRO+/FX/FX+ system. Patients who remain clinically stable 6 hours after the procedure will be discharged on the same day after completion of the required clinical assessments and discharge education. A follow-up telephone assessment will be performed on the day after the procedure.

Other: Same-Day Discharge Strategy

Standard-of-Care Discharge

ACTIVE COMPARATOR

Participants randomized to the control arm will receive standard inpatient post-procedural care and will be discharged according to local standard clinical practice (next-day or later discharge).

Other: Standard-of-Care Discharge Strategy

Interventions

Same-Day Discharge Strategy OTHER

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.

Same-Day Discharge

Standard-of-Care Discharge Strategy OTHER

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.

Standard-of-Care Discharge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Clinical stability 6 hours after TAVI
• Written informed consent obtained before study participation

You may not qualify if:

• Inability to ambulate independently at baseline
• Hemodynamic or clinical instability before TAVI
• Urgent or emergent TAVI procedure
• Non-transfemoral access
• Inadequate social support for discharge home
• Inability to understand or comply with post-discharge instructions
• Baseline right bundle branch block or high-grade atrioventricular block
• Baseline left ventricular ejection fraction \<20%
• Severe chronic kidney disease (estimated glomerular filtration rate : eGFR \<30 mL/min/1.73 m² or dialysis).
• Type 2-4 bleeding within 6 hours after TAVI
• New-onset left bundle branch block or high-grade atrioventricular block within 6 hours after TAVI, unless a permanent pacemaker has already been implanted
• New-onset atrial fibrillation within 6 hours after TAVI
• Persistent hemodynamic instability within 6 hours after TAVI

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (3)

Institut Universitaire de cardiologie et de pneumologie de Quebec

Québec, Quebec, G1Y 3K4, Canada

Location

Hospital Clínic de Barcelona

Barcelona, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Spain

Location

Related Publications (9)

• Russo MJ, Okoh AK, Stump K, Smith M, Erinne I, Johannesen J, Chaudhary A, Chiricolo A, Hakeem A, Lemaire A, Lee LY, Chen C. Safety and Feasibility of Same Day Discharge after Transcatheter Aortic Valve Replacement Post COVID-19. Struct Heart. 2021 Mar-Apr;5(2):182-185. doi: 10.1080/24748706.2020.1853861. Epub 2022 Mar 21. No abstract available.

  PMID: 35378799 BACKGROUND

• Goel A, Malik AH, Bandyopadhyay D, Chakraborty S, Gupta R, Abbott JD, Ahmad H. The 30-Day Readmission Rate of Same-Day Discharge Following Transcatheter Aortic Valve Implantation (from National Readmission Database 2015 to 2019). Am J Cardiol. 2022 Aug 1;176:112-117. doi: 10.1016/j.amjcard.2022.04.033. Epub 2022 May 27.

  PMID: 35644697 BACKGROUND

• Zahid S, Rai D, Tanveer Ud Din M, Khan MZ, Ullah W, Usman Khan M, Thakkar S, Hussein A, Baibhav B, Rao M, Abtahian F, Bhatt DL, Depta JP. Same-Day Discharge After Transcatheter Aortic Valve Implantation: Insights from the Nationwide Readmission Database 2015 to 2019. J Am Heart Assoc. 2022 Jun 7;11(11):e024746. doi: 10.1161/JAHA.121.024746. Epub 2022 May 27.

  PMID: 35621233 BACKGROUND

• Cepas-Guillen P, Vidal-Cales P, Gabani R, Espinosa T, Trilla M, Regueiro A. Initial experience of same-day discharge after transcatheter aortic valve implantation. Rev Esp Cardiol (Engl Ed). 2023 Sep;76(9):743-745. doi: 10.1016/j.rec.2023.03.020. Epub 2023 May 16. No abstract available. English, Spanish.

  PMID: 37201715 BACKGROUND

• Grubb KJ, Gada H, Mittal S, Nazif T, Rodes-Cabau J, Fraser DGW, Lin L, Rovin JD, Khalil R, Sultan I, Gardner B, Lorenz D, Chetcuti SJ, Patel NC, Harvey JE, Mahoney P, Schwartz B, Jafar Z, Wang J, Potluri S, Vora AN, Sanchez C, Corrigan A, Li S, Yakubov SJ. Clinical Impact of Standardized TAVR Technique and Care Pathway: Insights From the Optimize PRO Study. JACC Cardiovasc Interv. 2023 Mar 13;16(5):558-570. doi: 10.1016/j.jcin.2023.01.016.

  PMID: 36922042 BACKGROUND

• Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Pibarot P, Leipsic J, Hahn RT, Blanke P, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Szeto WY, Genereux P, Pershad A, Pocock SJ, Alu MC, Webb JG, Smith CR; PARTNER 3 Investigators. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1695-1705. doi: 10.1056/NEJMoa1814052. Epub 2019 Mar 16.

  PMID: 30883058 BACKGROUND

• Popma JJ, Deeb GM, Yakubov SJ, Mumtaz M, Gada H, O'Hair D, Bajwa T, Heiser JC, Merhi W, Kleiman NS, Askew J, Sorajja P, Rovin J, Chetcuti SJ, Adams DH, Teirstein PS, Zorn GL 3rd, Forrest JK, Tchetche D, Resar J, Walton A, Piazza N, Ramlawi B, Robinson N, Petrossian G, Gleason TG, Oh JK, Boulware MJ, Qiao H, Mugglin AS, Reardon MJ; Evolut Low Risk Trial Investigators. Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1706-1715. doi: 10.1056/NEJMoa1816885. Epub 2019 Mar 16.

  PMID: 30883053 BACKGROUND

• Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, Capodanno D, Conradi L, De Bonis M, De Paulis R, Delgado V, Freemantle N, Gilard M, Haugaa KH, Jeppsson A, Juni P, Pierard L, Prendergast BD, Sadaba JR, Tribouilloy C, Wojakowski W; ESC/EACTS Scientific Document Group. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2022 Feb 12;43(7):561-632. doi: 10.1093/eurheartj/ehab395. No abstract available.

  PMID: 34453165 BACKGROUND

• Writing Committee Members; Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP 3rd, Gentile F, Jneid H, Krieger EV, Mack M, McLeod C, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A, Toly C. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2021 Feb 2;77(4):450-500. doi: 10.1016/j.jacc.2020.11.035. Epub 2020 Dec 17.

  PMID: 33342587 BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Josep Rodes-Cabau, Md, PhD

  Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

  STUDY DIRECTOR

Central Study Contacts

Ander Regueiro, MD

CONTACT

+34932275400; AREGUEIR@clinic.cat

Emilie Pelletier Beaumont, Msc

CONTACT

1-418-656-8711; emilie.pelletier-beaumont@criucpq.ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study is open-label with respect to patients and treating providers. However, to minimize bias, statistical analyses will be conducted by a statistician blinded to group allocation whenever feasible.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 31, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: July 31, 2026

Record last verified: 2026-07

Locations

CA (1); ES (2)