Evaluation of the Viability and Safety of Early Discharge Protocol After TAVI Implantation
NCT ID: NCT05758909
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
585 participants
OBSERVATIONAL
2023-04-04
2026-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients receiving transfemoral (TF) TAVI
TF TAVI
TF TAVI
Follow-up Observation of patients having received a TF-TAVI
Interventions
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TF TAVI
Follow-up Observation of patients having received a TF-TAVI
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Fundación EPIC
OTHER
Responsible Party
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Locations
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Hospital Universitario A Coruña
A Coruña, , Spain
Hospital General Universitario Dr. Balmis
Alicante, , Spain
Hospital Clinico San Carlos
Aravaca, , Spain
Hospital Universitari Germans Trias I Pujol
Badalona, , Spain
Hospital de Santa Creu I Sant Pau
Barcelona, , Spain
Hospital Universitari Vall Hebron
Barcelona, , Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, , Spain
Hospital Regional Universitario de Malaga
Málaga, , Spain
Hospital Universitario Central de Asturias
Oviedo, , Spain
Hospital Universitario de Navarra
Pamplona, , Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, , Spain
Hospital Universitario Virgen Del Rocio
Seville, , Spain
Hospital Universitari i Politècnic la Fe
Valencia, , Spain
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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EPIC19-FAST TRACK
Identifier Type: -
Identifier Source: org_study_id