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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03361007
Other study ID # WUM-CCA
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date May 30, 2024

Study information

Verified date October 2020
Source Medical University of Warsaw
Contact Kajetan Grodecki
Phone +48660675782
Email kajetan.grodecki@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date May 30, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Qualification for TAVI through common carotid artery by decision of the local Heart Team - Patient provided written informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Transcatheter Aortic Valve Implantation (TAVI)
Patients who were disqualified from surgical cortical valve replacement by decision of the Heart Team.

Locations

Country Name City State
Poland Medical University of Gdansk Gdansk
Poland Medical University of Silesia Katowice
Poland Medical University of Lodz Lódz
Poland University of Opole Opole
Poland Poznan University of Medical Sciences Poznan
Poland Medical University of Warsaw Warsaw

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
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