Polish Registry of Common Carotid Artery Access for TAVI

NCT ID: NCT03361007

Last Updated: 2020-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2024-05-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Aortic Valve Stenosis Ventricular Outflow Obstruction, Left

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Common carotid artery access for TAVI

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

Transcatheter Aortic Valve Implantation (TAVI)

Intervention Type DEVICE

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

Interventions

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Transcatheter Aortic Valve Implantation (TAVI)

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

Intervention Type DEVICE

Other Intervention Names

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Transcatheter Aortic Valve Replacement (TAVR)

Eligibility Criteria

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Inclusion Criteria

* Qualification for TAVI through common carotid artery by decision of the local Heart Team
* Patient provided written informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Warsaw

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zenon Huczek, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Warsaw

Radosław Wilimski, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Warsaw

Locations

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Medical University of Gdansk

Gdansk, , Poland

Site Status RECRUITING

Medical University of Silesia

Katowice, , Poland

Site Status RECRUITING

Medical University of Lodz

Lodz, , Poland

Site Status RECRUITING

University of Opole

Opole, , Poland

Site Status RECRUITING

Poznan University of Medical Sciences

Poznan, , Poland

Site Status RECRUITING

Medical University of Warsaw

Warsaw, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Kajetan Grodecki

Role: CONTACT

+48660675782

Facility Contacts

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Dariusz Jagielak, MD, PhD

Role: primary

Wojciech Wojakowski, MD, PhD

Role: primary

Andrzej Walczak, MD, PhD

Role: primary

Jerzy Sacha, MD, PhD

Role: primary

Marek Grygier, MD, PhD

Role: primary

Zenon Huczek, MD, PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 26189468 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24431170 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23846009 (View on PubMed)

Other Identifiers

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WUM-CCA

Identifier Type: -

Identifier Source: org_study_id

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