Evaluation of the Viability and Safety of Early Discharge Protocol After TAVI Implantation (FAST TRACK)

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

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases
• Intervention / Treatment: Device: TF TAVI

Detailed Description

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

• Study Type: Observational
• Enrollment (Anticipated): 585

Contacts and Locations

• Study Contact: Name: VICENTE SERRA GARCIA, MD; Phone Number: 0034932746155; Email: vctsrr@hotmail.com

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitari Vall Hebrón

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients receiving transfemoral (TF) TAVI; TF TAVI	Device: TF TAVI; Follow-up Observation of patients having received a TF-TAVI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Cardiovascular death	Assessment of Cardiovascular death	30 days
Assessment of Cardiovascular death	Assessment of Cardiovascular death	12 months
Assessment of Stroke	Incidence of patients with stroke diagnosed by a Neurologist according to VARC 3 criteria	30 days
Assessment of Stroke	Incidence of patients with stroke diagnosed by a Neurologist according to VARC 3 criteria	12 months
Assessment of Myocardial Infarction	Incidence of patients with Myocardial Infarction diagnosed by Cardiologist according to VARC 3 criteria	30 days
Assessment of Myocardial Infarction	Incidence of patients with Myocardial Infarction diagnosed by Cardiologist according to VARC 3 criteria	12 months
Assessment of Hospitalization for any reason	Incidence of patients with Hospitalization for any reason according to VARC 3 criteria	30 days
Assessment of Hospitalization for any reason	Incidence of patients with Hospitalization for any reason according to VARC 3 criteria	12 months
Assessments of Major Vascular Complications	Incidence of patients with Major Vascular Complications according to VARC 3 criteria	30 days
Assessments of Major Vascular Complications	Incidence of patients with Major Vascular Complications according to VARC 3 criteria	12 months
Assessments of need for pacemakers	Incidence of patients with need for pacemakers according to VARC 3 criteria	30 days
Assessments of need for pacemakers	Incidence of patients with need for pacemakers according to VARC 3 criteria	12 months
Assessment of hospitalization time	Incidence of patients with hospitalization according to VARC 3 criteria	at discharge
Assessment of hospitalization due cardiac reasons	Incidence of patients with hospitalization due cardiac reasons according to VARC 3 criteria	12 months
Assessment of hospitalization due cardiac reasons	Incidence of patients with hospitalization due cardiac reasons according to VARC 3 criteria	30 days

Collaborators and Investigators

• Sponsor: Fundación EPIC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2023
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: February 5, 2023
• First Submitted That Met QC Criteria: February 24, 2023
• First Posted (Actual): March 8, 2023

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Heart Valve Diseases; Aortic Valve Disease
• Other Study ID Numbers: EPIC19-FAST TRACK

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No