Evaluation of the Viability and Safety of Early Discharge Protocol After TAVI Implantation

Aortic Valve Stenosis Clinical Trial

— FAST TRACK  

Official title:

Evaluation of the Viability and Safety of Early Discharge Protocol After TAVI Implantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05758909
• Other study ID #: EPIC19-FAST TRACK
• Status: Recruiting
• Start date: April 4, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: June 2024
• Source: Fundación EPIC
• Contact: VICENTE SERRA GARCIA, MD
• Phone: 0034932746155
• Email: vctsrr[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 585
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Disease
• Aortic Valve Stenosis
• Heart Valve Diseases

Intervention

Device:
• TF TAVI
Follow-up Observation of patients having received a TF-TAVI

Locations

Country	Name	City	State
Spain	Hospital General Universitario Dr. Balmis	Alicante
Spain	Hospital de Santa Creu I Sant Pau	Barcelona
Spain	Hospital Universitari Vall Hebron	Barcelona
Spain	Hospital Universitario Central de Asturias	Oviedo
Spain	Hospital Universitario de Navarra	Pamplona
Spain	Hospital Universitari i Politècnic la Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Fundación EPIC

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

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