Polish Registry of Common Carotid Artery Access for TAVI

NCT03361007 | Unknown DMC FDA Device

• 1 other identifier: WUM-CCA
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 6

Brief Summary

Transcatheter aortic valve implantation (TAVI) is valuable treatment option for patients, who are at the high risk of surgical aortic valve replacement (AVR). Majority of procedures are performed through femoral arteries, however in some this access cannot be applied. Common carotid artery is one of the alternative routes of delivering the device in those patients. Established registry aims at collecting the data prospectively to assess outcomes of TAVI through common carotid artery.

Conditions

Aortic Valve Stenosis; Ventricular Outflow Obstruction, Left

Keywords

TAVI; common carotid artery

Outcome Measures

Primary Outcomes (1)

• VARC (Valve Academic Research Consortium-2) defined "Clinical Efficacy" composite endpoint

  * All-cause mortality * All stroke (disabling and non-disabling) * Requiring hospitalizations for valve-related symptoms or worsening congestive heart failure * NYHA (New York Heart Association) class III or IV functional classification of heart failure * Valve-related dysfunction (mean aortic valve gradient ≥20 mmHg, Effective Orifice Area (EOA) ≤0.9-1.1 cm2(c) and/or Doppler Velocity Integral (DVI) \<0. 35 m/s, AND/OR moderate or severe prosthetic valve regurgitation

  From 30 days post procedure to completion of at least 2 years of follow up

Secondary Outcomes (3)

• VARC defined 'Device success' composite endpoint

  30 days

• VARC defined "Early Safety" composite endpoint

  30 days

• VARC defined "Time-related valve safety" composite endpoint

  From device implant to completion of at least 2 years of follow up

Study Arms (1)

Common carotid artery access for TAVI

Patients in whom femoral artery could not be used to deliver the bioprosthesis for any reason.

Device: Transcatheter Aortic Valve Implantation (TAVI)

Interventions

Transcatheter Aortic Valve Implantation (TAVI) DEVICE

Patients who were disqualified from surgical cortical valve replacement by decision of the Heart Team.

Also known as: Transcatheter Aortic Valve Replacement (TAVR)

Common carotid artery access for TAVI

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 meeting inclusion criteria will prospectively included in the study. Patients meeting inclusion criteria before the set-up of registry will be included retrospectively.

You may qualify if:

• Qualification for TAVI through common carotid artery by decision of the local Heart Team
• Patient provided written informed consent

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (6)

Medical University of Gdansk

Gdansk, Poland

RECRUITING

Medical University of Silesia

Katowice, Poland

RECRUITING

Medical University of Lodz

Lodz, Poland

RECRUITING

University of Opole

Opole, Poland

RECRUITING

Poznan University of Medical Sciences

Poznan, Poland

RECRUITING

Medical University of Warsaw

Warsaw, Poland

RECRUITING

Related Publications (3)

• Huczek Z, Wilimski R, Kochman J, Szczudlik P, Scislo P, Rymuza B, Kaplon-Cieslicka A, Kolasa A, Marchel M, Filipiak KJ, Cichon R, Opolski G. Common carotid artery access for transcatheter aortic valve implantation. Kardiol Pol. 2015;73(7):478-84. doi: 10.5603/KP.2015.0122.

  PMID: 26189468 BACKGROUND

• Azmoun A, Amabile N, Ramadan R, Ghostine S, Caussin C, Fradi S, Raoux F, Brenot P, Nottin R, Deleuze P. Transcatheter aortic valve implantation through carotid artery access under local anaesthesia. Eur J Cardiothorac Surg. 2014 Oct;46(4):693-8; discussion 698. doi: 10.1093/ejcts/ezt619. Epub 2014 Jan 14.

  PMID: 24431170 BACKGROUND

• Schirmer J, Conradi L, Seiffert M, Koschyk D, Blankenberg S, Reichenspurner H, Diemert P, Treede H. Transcatheter aortic valve implantation: alternative access options. Minerva Cardioangiol. 2013 Aug;61(4):429-35.

  PMID: 23846009 BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis; Ventricular Outflow Obstruction, Left

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 Officials

• Zenon Huczek, MD, PhD

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

• Radosław Wilimski, MD

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kajetan Grodecki

CONTACT

+48660675782; kajetan.grodecki@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 4, 2017
• Study Start: January 1, 2018
• Primary Completion: December 31, 2023
• Study Completion: May 30, 2024
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

PL (6)