Polish Registry of Common Carotid Artery Access for TAVI

Aortic Valve Stenosis Clinical Trial

— POL-CAROTID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03361007
• Other study ID #: WUM-CCA
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Ventricular Outflow Obstruction
• Ventricular Outflow Obstruction, Left

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