Polish Registry of Common Carotid Artery Access for TAVI

• Conditions: Aortic Valve Stenosis; Ventricular Outflow Obstruction, Left
• Interventions: Device: Transcatheter Aortic Valve Implantation (TAVI)

• Registration Number: NCT03361007
• Lead Sponsor: Medical University of Warsaw

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.

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 Timeline

• Study First Submitted: 2017-11-28
• Study First Submitted QC: 2017-11-28
• Study First Posted: 2017-12-04
• Study Start: 2018-01-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-20
• Last Update Posted: 2020-10-22
• Primary Completion: 2023-12-31
• Study Completion: 2024-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Common carotid artery access for TAVI	Transcatheter Aortic Valve Implantation (TAVI)	Patients in whom femoral artery could not be used to deliver the bioprosthesis for any reason.

Primary Outcome Measures

Name	Time	Method
VARC (Valve Academic Research Consortium-2) defined "Clinical Efficacy" composite endpoint	From 30 days post procedure to completion of at least 2 years of follow up	* 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

Secondary Outcome Measures

Name	Time	Method
VARC defined "Time-related valve safety" composite endpoint	From device implant to completion of at least 2 years of follow up	* 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)
VARC defined "Early Safety" composite endpoint	30 days	* 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))
VARC defined 'Device success' composite endpoint	30 days	* 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)

Trial Locations

Locations (6)

Medical University of Silesia; 🇵🇱 Katowice, Poland

University of Opole; 🇵🇱 Opole, Poland

Medical University of Warsaw; 🇵🇱 Warsaw, Poland

Medical University of Lodz; 🇵🇱 Łódź, Poland

Medical University of Gdansk; 🇵🇱 Gdańsk, Poland

Poznan University of Medical Sciences; 🇵🇱 Poznań, Poland