Polish Registry of Common Carotid Artery Access for TAVI (POL-CAROTID)

Evaluation of Clinical Outcomes of Transcatheter Aortic Valve Implantation Through Common Carotid Artery Access in Polish Population - Observational Multicenter Registry

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Stenosis; Ventricular Outflow Obstruction, Left
• Intervention / Treatment: Device: Transcatheter Aortic Valve Implantation (TAVI)

Detailed Description

The study is a prospective multicenter evaluation of transcatheter aortic valve implantations through common carotid artery in Polish health centers.

Duration of this study is expected to be 6 years to ensure that all of the enrolled patients will complete at least 2 years of follow-up.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Poland
  • Gdańsk, Poland
    • Recruiting
    • Medical University of Gdansk
  • Katowice, Poland
    • Recruiting
    • Medical University of Silesia
  • Opole, Poland
    • Recruiting
    • University of Opole
    • Contact: Jerzy Sacha, MD, PhD
  • Poznań, Poland
    • Recruiting
    • Poznan University of Medical Sciences
  • Warsaw, Poland
    • Recruiting
    • Medical University of Warsaw
  • Łódź, Poland
    • Recruiting
    • Medical University of Lodz
    • Contact: Andrzej Walczak, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); Patients who were disqualified from surgical cortical valve replacement by decision of the Heart Team.; Other Names: Transcatheter Aortic Valve Replacement (TAVR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
VARC defined 'Device success' composite endpoint	Absence of procedural mortality AND; Correct positioning of a single prosthetic heart valve into the proper anatomical location AND; Intended performance of the prosthetic heart valve (no prosthesis - patient mismatch and mean aortic valve gradient ,20 mmHg or peak velocity ,3 m/s, AND no moderate or severe prosthetic valve regurgitation)	30 days
VARC defined "Early Safety" composite endpoint	All-cause mortality; All stroke (disabling and non-disabling); Life-threatening bleeding; Acute kidney injury-Stage 2 or 3 (including renal replacement therapy); Coronary artery obstruction requiring intervention; Major vascular complication; Valve-related dysfunction requiring repeat procedure (Balloon Aortic Valvuloplasty (BAV), Trans Catheter Aortic Valve Implant (TAVI), or Surgical Aortic Valve Replacement (SAVR))	30 days
VARC defined "Time-related valve safety" composite endpoint	Structural valve deterioration; Valve-related dysfunction (mean aortic valve gradient ≥20 mmHg, EOA ≤0.9-1.1 cm2cand/or DVI <0.35 m/s, AND/OR moderate or severe prosthetic valve regurgitation); Requiring repeat procedure (TAVI or SAVR); Prosthetic valve endocarditis; Prosthetic valve thrombosis; Thrombo-embolic events (e.g. stroke); VARC bleeding, unless clearly unrelated to valve therapy (e.g. trauma)	From device implant to completion of at least 2 years of follow up

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Investigators: Principal Investigator: Radosław Wilimski, MD, Medical University of Warsaw

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): May 30, 2024

Study Registration Dates

• First Submitted: November 28, 2017
• First Submitted That Met QC Criteria: November 28, 2017
• First Posted (ACTUAL): December 4, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: TAVI; common carotid artery
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Aortic Valve Stenosis; Ventricular Outflow Obstruction
• Other Study ID Numbers: WUM-CCA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes