Fast Track Concept for Transfemoral TAVI

NCT04792827 | Completed

• 1 other identifier: IN-TF_TAVI_01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Transcatheter aortic valve implantation (TAVI) in high-risk patients with severe aortic valve stenosis has developed itself until today as an established minimally invasive alternative procedure worldwide, with a focus on the transfemoral access (TF-TAVI). Meanwhile a number of studies have shown that analgosedation for patients undergoing TF-TAVI is a safe and feasible alternative to general anaesthesia (1). The median length of stay in hospital in Europe is currently 8 days independent to the anesthesia management (2). In the University Hospital Schleswig-Holstein, Campus Kiel, a new TF-TAVI fast-track-concept has been implemented in June 2018. The main intraprocedural aspects of the concept are the preprocedural fluid optimization using transthoracic echocardiography, the idea to decrease or omit the central venous line and the urinary catheter, if reasonable, and finally the individualized low-dose, bolus-based AS.

Conditions

Heart Valve Diseases; Complication,Postoperative

Keywords

length of stay in hospital; transfemoral transaortic valve implantation

Outcome Measures

Primary Outcomes (1)

• length of stay in hospital

  time in hospital

  through study completion, an average of 1 year

Secondary Outcomes (2)

• postoperative complications

  through study completion, an average of 1 year

• one year mortality

  through study completion, an average of 1 year

Study Arms (2)

analgosedation group

analgosedation concept

historical group

standard historical concept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

TAVI-patients

You may qualify if:

• scheduled for transfemoral TAVI
• informed written consent

You may not qualify if:

• rejection by the patient
• switching to another procedure

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (1)

Universitätsklinikum Schleswig-Holstein Campus Kiel - Klinik für Anästhesiologie und Operative Intensivmedizin

Kiel, Deutschland (deu), 24105, Germany

Location

Related Publications (2)

• Renner J, Tesdorpf A, Freitag-Wolf S, Francksen H, Petzina R, Lutter G, Frey N, Frank D. A retrospective study of conscious sedation versus general anaesthesia in patients scheduled for transfemoral aortic valve implantation: A single center experience. Health Sci Rep. 2018 Nov 1;2(1):e95. doi: 10.1002/hsr2.95. eCollection 2019 Jan.

  PMID: 30697594 BACKGROUND

• Brecker SJ, Bleiziffer S, Bosmans J, Gerckens U, Tamburino C, Wenaweser P, Linke A; ADVANCE Study Investigators. Impact of Anesthesia Type on Outcomes of Transcatheter Aortic Valve Implantation (from the Multicenter ADVANCE Study). Am J Cardiol. 2016 Apr 15;117(8):1332-8. doi: 10.1016/j.amjcard.2016.01.027. Epub 2016 Jan 28.

  PMID: 26892451 BACKGROUND

MeSH Terms

Conditions

Heart Valve Diseases; Postoperative Complications

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Jochen Renner

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: March 11, 2021
• Study Start: June 1, 2018
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: March 11, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)