LUS in Aortic Stenosis Patients Undergoing TAVR

NCT05024942 | Unknown DMC FDA Device

• 1 other identifier: ID 3965
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

• Demographic and clinical data documentation;
• Clinical examination: before TAVR, before discharge and when adverse events occur;
• Blood analysis;
• TAVR procedural characteristics and complications.
• Instrumental diagnostic exams (Echocardiography and lung ultrasound):
• Clinical follow up assessment:

Conditions

Transcatheter Aortic Valve Replacement; Lung Ultrasound; Severe Aortic Valve Stenosis; Pulmonary Congestion

Outcome Measures

Primary Outcomes (1)

• change of LUS-evaluated pulmonary congestion in patients with severe aortic stenosis undergoing TAVR

  pre-intervention (baseline) and after the intervention within 72 hours

Secondary Outcomes (1)

• to evaluate the possible prognostic role of LUS-evaluated pulmonary congestion at 12 months follow-up.

  One year after hospital discharge.

Study Arms (1)

Severe aortic stenosis patients undergoing TAVR

Severe aortic stenosis patients undergoing TAVR will be stratified according to LUS evaluated pulmonary congestion before and after TAVR

Procedure: Transfemoral TAVR (Transcatheter aortic valve replacement)

Interventions

Transfemoral TAVR (Transcatheter aortic valve replacement) PROCEDURE

Transfemoral transcatheter aortic valve replacement (TAVR) is a minimally invasive heart procedure to replace a narrowed aortic valve that fails to open properly (aortic valve stenosis) through an incision in the groin. All FDA approved transcatheter aortic prosthesys are allowed.

Severe aortic stenosis patients undergoing TAVR

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

All patients undergoing TAVR for severe aortic stenosis could participate in the study and therefore, be evaluated according to the selection criteria defined in the protocol.

You may qualify if:

• severe aortic stenosis,
• life expectancy \>1 year,
• patient candidate to percutaneous transfemoral aortic valve implantation after formal indication of our "Heart Team".

You may not qualify if:

• clinical history of lung cancer or lung surgery, fibrothorax and pneumothorax, pulmonary fibrosis,
• patients undergoing urgent aortic valvuloplasty,
• patients admitted for cardiogenic shock,
• recent (within 1 month) pneumonia or ARDS (Acute Respiratory Distress Syndrome),
• lack of will to participate,
• more than moderate aortic regurgitation,
• valve-in-valve procedures,
• transapical and transaortic TAVR.

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead
• Francesca Graziani, MD: collaborator
• Stefano Cangemi, MD: collaborator

Study Sites (1)

Policlinico A. Gemelli. Università Cattolica del Sacro Cuore

Rome, 00168, Italy

RECRUITING

Related Publications (14)

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• Genereux P, Pibarot P, Redfors B, Mack MJ, Makkar RR, Jaber WA, Svensson LG, Kapadia S, Tuzcu EM, Thourani VH, Babaliaros V, Herrmann HC, Szeto WY, Cohen DJ, Lindman BR, McAndrew T, Alu MC, Douglas PS, Hahn RT, Kodali SK, Smith CR, Miller DC, Webb JG, Leon MB. Staging classification of aortic stenosis based on the extent of cardiac damage. Eur Heart J. 2017 Dec 1;38(45):3351-3358. doi: 10.1093/eurheartj/ehx381.

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  PMID: 32668323 BACKGROUND

• Lillo R, Cangemi S, Graziani F, Locorotondo G, Pedicino D, Aurigemma C, Romagnoli E, Malara S, Meucci MC, Iannaccone G, Bianchini F, Nesta M, Bruno P, Lombardo A, Trani C, Burzotta F. Pulmonary congestion assessed by lung ultrasound in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation: Prevalence and prognostic implications. Eur J Heart Fail. 2024 Oct;26(10):2107-2117. doi: 10.1002/ejhf.3365. Epub 2024 Jul 16.

  PMID: 39014551 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, interventional cardiologist

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 27, 2021
• Study Start: July 20, 2021
• Primary Completion: April 30, 2022
• Study Completion: June 30, 2022
• Last Updated: August 27, 2021

Record last verified: 2021-08

Locations

IT (1)