NCT05758909

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
585

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Apr 2023

Typical duration for all trials

Geographic Reach
1 country

13 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Apr 2023Dec 2026

First Submitted

Initial submission to the registry

February 5, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 8, 2023

Completed
27 days until next milestone

Study Start

First participant enrolled

April 4, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

3.7 years

First QC Date

February 5, 2023

Last Update Submit

December 15, 2025

Conditions

Aortic Valve StenosisHeart Valve DiseasesAortic Valve Disease

Outcome Measures

Primary Outcomes (1)

  • Assessment of early safety

    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 Outcomes (15)

  • Assessment of Cardiovascular death

    30 days

  • Assessment of Cardiovascular death

    12 months

  • Assessment of Stroke

    30 days

  • Assessment of Stroke

    12 months

  • Assessment of Myocardial Infarction

    30 days

  • +10 more secondary outcomes

Study Arms (1)

Patients receiving transfemoral (TF) TAVI

TF TAVI

Device: TF TAVI

Interventions

TF TAVIDEVICE

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

Patients receiving transfemoral (TF) TAVI

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Hospital Universitario A Coruña

A Coruña, 15006, Spain

Location

Hospital General Universitario Dr. Balmis

Alicante, 03010, Spain

Location

Hospital Clinico San Carlos

Aravaca, 28040, Spain

Location

Hospital Universitari Germans Trias I Pujol

Badalona, 08916, Spain

Location

Hospital de Santa Creu I Sant Pau

Barcelona, 08025, Spain

Location

Hospital Universitari Vall Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, 08907, Spain

Location

Hospital Regional Universitario de Malaga

Málaga, 29010, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, 33011, Spain

Location

Hospital Universitario de Navarra

Pamplona, 31008, Spain

Location

Hospital Clinico Universitario de Santiago

Santiago de Compostela, 15706, Spain

Location

Hospital Universitario Virgen Del Rocio

Seville, 41013, Spain

Location

Hospital Universitari i Politècnic la Fe

Valencia, 46026, Spain

Location

Related Publications (6)

  • Barbanti M, van Mourik MS, Spence MS, Iacovelli F, Martinelli GL, Muir DF, Saia F, Bortone AS, Densem CG, van der Kley F, Bramlage P, Vis M, Tamburino C. Optimising patient discharge management after transfemoral transcatheter aortic valve implantation: the multicentre European FAST-TAVI trial. EuroIntervention. 2019 Jun 20;15(2):147-154. doi: 10.4244/EIJ-D-18-01197.

    PMID: 30777842BACKGROUND

  • van Gils L, Baart S, Kroon H, Rahhab Z, El Faquir N, Rodriguez Olivares R, Aga Y, Maugenest AM, Theuns DA, Boersma E, Szili Torok T, De Jaegere PP, Van Mieghem NM. Conduction dynamics after transcatheter aortic valve implantation and implications for permanent pacemaker implantation and early discharge: the CONDUCT-study. Europace. 2018 Dec 1;20(12):1981-1988. doi: 10.1093/europace/euy074.

    PMID: 29688322BACKGROUND

  • Aldalati O, Keshavarzi F, Kaura A, Byrne J, Eskandari M, Deshpande R, Monaghan M, Wendler O, Dworakowski R, MacCarthy P. Factors associated with safe early discharge after transcatheter aortic valve implantation. Cardiol J. 2018;25(1):14-23. doi: 10.5603/CJ.a2017.0087. Epub 2017 Jul 17.

    PMID: 28714522BACKGROUND

  • Serletis-Bizios A, Durand E, Cellier G, Tron C, Bauer F, Glinel B, Dacher JN, Cribier A, Eltchaninoff H. A Prospective Analysis of Early Discharge After Transfemoral Transcatheter Aortic Valve Implantation. Am J Cardiol. 2016 Sep 15;118(6):866-872. doi: 10.1016/j.amjcard.2016.06.035. Epub 2016 Jun 27.

    PMID: 27453514BACKGROUND

  • Chandrasekhar J, Mehran R. Same or next day discharge: A new chapter in transcatheter aortic valve implantation. Catheter Cardiovasc Interv. 2016 Jan 1;87(1):143-4. doi: 10.1002/ccd.26388.

    PMID: 27410958BACKGROUND

  • Wood DA, Lauck SB, Cairns JA, Humphries KH, Cook R, Welsh R, Leipsic J, Genereux P, Moss R, Jue J, Blanke P, Cheung A, Ye J, Dvir D, Umedaly H, Klein R, Rondi K, Poulter R, Stub D, Barbanti M, Fahmy P, Htun N, Murdoch D, Prakash R, Barker M, Nickel K, Thakkar J, Sathananthan J, Tyrell B, Al-Qoofi F, Velianou JL, Natarajan MK, Wijeysundera HC, Radhakrishnan S, Horlick E, Osten M, Buller C, Peterson M, Asgar A, Palisaitis D, Masson JB, Kodali S, Nazif T, Thourani V, Babaliaros VC, Cohen DJ, Park JE, Leon MB, Webb JG. The Vancouver 3M (Multidisciplinary, Multimodality, But Minimalist) Clinical Pathway Facilitates Safe Next-Day Discharge Home at Low-, Medium-, and High-Volume Transfemoral Transcatheter Aortic Valve Replacement Centers: The 3M TAVR Study. JACC Cardiovasc Interv. 2019 Mar 11;12(5):459-469. doi: 10.1016/j.jcin.2018.12.020.

    PMID: 30846085BACKGROUND

MeSH Terms

Conditions

Aortic Valve DiseaseAortic Valve StenosisHeart Valve Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2023

First Posted

March 8, 2023

Study Start

April 4, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

December 19, 2025

Record last verified: 2025-12

Locations

ES(13)