FAST TRACK: Evaluation of the Viability and Safety of Early Discharge Protocol After TAVI Implantation
Study Details
Study Description
Brief Summary
Evaluation of the safety and efficacy of early discharge (24 hours) after transfemoral transcatheter aortic prosthesis implantation (TAVI).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Evaluation of the safety and efficacy of early discharge (24 hours) after transfemoral transcatheter aortic prosthesis implantation (TAVI).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients receiving transfemoral (TF) TAVI TF TAVI |
Device: TF TAVI
Follow-up Observation of patients having received a TF-TAVI
|
Outcome Measures
Primary Outcome Measures
- Assessment of early safety [30 days]
Proportion of patients with early safety defined as: Cardiovascular death. Stroke. Myocardial Infarction. Hospitalization for any reason . Major vascular complications. Need for pacemakers.
Secondary Outcome Measures
- Assessment of Cardiovascular death [30 days]
Assessment of Cardiovascular death
- Assessment of Cardiovascular death [12 months]
Assessment of Cardiovascular death
- Assessment of Stroke [30 days]
Incidence of patients with stroke diagnosed by a Neurologist according to VARC 3 criteria
- Assessment of Stroke [12 months]
Incidence of patients with stroke diagnosed by a Neurologist according to VARC 3 criteria
- Assessment of Myocardial Infarction [30 days]
Incidence of patients with Myocardial Infarction diagnosed by Cardiologist according to VARC 3 criteria
- Assessment of Myocardial Infarction [12 months]
Incidence of patients with Myocardial Infarction diagnosed by Cardiologist according to VARC 3 criteria
- Assessment of Hospitalization for any reason [30 days]
Incidence of patients with Hospitalization for any reason according to VARC 3 criteria
- Assessment of Hospitalization for any reason [12 months]
Incidence of patients with Hospitalization for any reason according to VARC 3 criteria
- Assessments of Major Vascular Complications [30 days]
Incidence of patients with Major Vascular Complications according to VARC 3 criteria
- Assessments of Major Vascular Complications [12 months]
Incidence of patients with Major Vascular Complications according to VARC 3 criteria
- Assessments of need for pacemakers [30 days]
Incidence of patients with need for pacemakers according to VARC 3 criteria
- Assessments of need for pacemakers [12 months]
Incidence of patients with need for pacemakers according to VARC 3 criteria
- Assessment of hospitalization time [at discharge]
Incidence of patients with hospitalization according to VARC 3 criteria
- Assessment of hospitalization due cardiac reasons [12 months]
Incidence of patients with hospitalization due cardiac reasons according to VARC 3 criteria
- Assessment of hospitalization due cardiac reasons [30 days]
Incidence of patients with hospitalization due cardiac reasons according to VARC 3 criteria
Eligibility Criteria
Criteria
Inclusion Criteria:
Patients who meet all of the following conditions will be included:
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Patients ≥ 18 years undergoing transfemoral TAVI implantation scheduled, performed on an outpatient basis.
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Patients with percutaneous implant.
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Patients undergoing the procedure under superficial sedation or Local anesthesia.
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Patients with baseline narrow QRS that does not change after implantation, or definitive pacemaker carrier.
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Patients who have signed the informed consent.
Exclusion Criteria:
Patients who do not meet any of the following conditions:
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Patients with a wide QRS (greater than or equal to 120 msec) at baseline, with the except for patients with permanent pacemakers.
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Hospitalized patients undergoing urgent TAVI implantation.
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Patients with access other than percutaneous transfemoral.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Fundación EPIC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- EPIC19-FAST TRACK