Clinical trial NCT05758909: Evaluation of the Viability and Safety of Early Discharge Protocol After TAVI Implantation
Official title: Evaluation of the Viability and Safety of Early Discharge Protocol After TAVI Implantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Valve Disease
Aortic Valve Stenosis
Heart Valve Diseases
Lead sponsor: Fundación EPIC
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 585
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing scheduled transfemoral TAVI implantation, performed on an outpatient basis

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

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

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of early safety
timeFrame: 30 days
Secondary outcomes:
measure: Assessment of Cardiovascular death
timeFrame: 30 days
measure: Assessment of Cardiovascular death
timeFrame: 12 months
measure: Assessment of Stroke
timeFrame: 30 days
measure: Assessment of Stroke
timeFrame: 12 months
measure: Assessment of Myocardial Infarction
timeFrame: 30 days
measure: Assessment of Myocardial Infarction
timeFrame: 12 months
measure: Assessment of Hospitalization for any reason
timeFrame: 30 days
measure: Assessment of Hospitalization for any reason
timeFrame: 12 months
measure: Assessments of Major Vascular Complications
timeFrame: 30 days
measure: Assessments of Major Vascular Complications
timeFrame: 12 months
measure: Assessments of need for pacemakers
timeFrame: 30 days
measure: Assessments of need for pacemakers
timeFrame: 12 months
measure: Assessment of hospitalization time
timeFrame: at discharge
measure: Assessment of hospitalization due cardiac reasons
timeFrame: 12 months
measure: Assessment of hospitalization due cardiac reasons
timeFrame: 30 days
Other outcomes:
Locations:
city: A Coruña
country: Spain
facility: Hospital Universitario A Coruña
city: Alicante
country: Spain
facility: Hospital General Universitario Dr. Balmis
city: Aravaca
country: Spain
facility: Hospital Clinico San Carlos
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias I Pujol
city: Barcelona
country: Spain
facility: Hospital de Santa Creu I Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitari Vall Hebron
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitario de Bellvitge
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Malaga
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra
city: Santiago De Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic la Fe
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.