Aortic Valve StenosisPOL-CAROTIDNCT03361007
Polish Registry of Common Carotid Artery Access for TAVI
An observational study of Aortic Valve Stenosis and Ventricular Outflow Obstruction, Left, run by Medical University of Warsaw at 6 sites in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Ventricular Outflow Obstruction, Left
- What is being tested?
- Transcatheter Aortic Valve Implantation (TAVI)
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 6 sitesPoland
- Study dates
- 1 Jan 2018to 30 May 2024
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Qualification for TAVI through common carotid artery by decision of the local Heart Team
- Patient provided written informed consent
Who cannot join
None listed.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Poland6 sites, 6 recruiting
- Recruiting
Medical University of Gdansk
Gdansk
Dariusz Jagielak, MD, PhD
- Recruiting
Medical University of Silesia
Katowice
Wojciech Wojakowski, MD, PhD
- Recruiting
Medical University of Lodz
Lodz
Andrzej Walczak, MD, PhD
- Recruiting
University of Opole
Opole
Jerzy Sacha, MD, PhD
- Recruiting
Poznan University of Medical Sciences
Poznan
Marek Grygier, MD, PhD
- Recruiting
Medical University of Warsaw
Warsaw
Zenon Huczek, MD, PhD
Kajetan Grodecki
About this study
Official title: 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.
Read the 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.
- Being tested
- Transcatheter Aortic Valve Implantation (TAVI)
- Keywords
- TAVI, common carotid artery
- Medical subject headings
- Aortic Valve Stenosis, Ventricular Outflow Obstruction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Aortic Valve Implantation (TAVI)Device
Also called Transcatheter Aortic Valve Replacement (TAVR)
Patients who were disqualified from surgical cortical valve replacement by decision of the Heart Team.
| Study group | Role | What they receive |
|---|---|---|
| Common carotid artery access for TAVI | Patients in whom femoral artery could not be used to deliver the bioprosthesis for any reason. Receives: Device: Transcatheter Aortic Valve Implantation (TAVI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From 30 days post procedure to completion of at least 2 years of follow up
Secondary outcomes (3)
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)
Measured: 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))
Measured: 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)
Measured: From device implant to completion of at least 2 years of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start1 Jan 2018
- Primary completion31 Dec 2023 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zenon Huczek, MD, PhD, Principal investigator, Medical University of WarsawRadosław Wilimski, MD, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03361007
- Sponsor's protocol ID
- WUM-CCA
- Acronym
- POL-CAROTID
- Status last verified
- Oct 2020
- First submitted
- 28 Nov 2017
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 26189468Azmoun 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.
PubMed 24431170Schirmer 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.
PubMed 23846009
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Outcomes of Transcatheter Aortic Valve Implantation Through Common Carotid Artery Access in Polish Population - Observational Multicenter Registry
- ClinicalTrials.gov ID
- NCT03361007
- Acronym / sponsor ID
- POL-CAROTID / WUM-CCA
- Keywords
- TAVI, common carotid artery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 4 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Common carotid artery access for TAVI | – | Device: Transcatheter Aortic Valve Implantation (TAVI)Patients in whom femoral artery could not be used to deliver the bioprosthesis for any reason. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Qualification for TAVI through common carotid artery by decision of the local Heart Team
- Patient provided written informed consent
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter Aortic Valve Implantation (TAVI)Also: Transcatheter Aortic Valve Replacement (TAVR)Patients who were disqualified from surgical cortical valve replacement by decision of the Heart Team. | Device | Common carotid artery access for TAVI |
Primary outcome
VARC (Valve Academic Research Consortium-2) defined "Clinical Efficacy" composite endpoint
Time frame: 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
3 secondary outcomes
VARC defined 'Device success' composite endpoint
Time frame: 30 days
VARC defined "Early Safety" composite endpoint
Time frame: 30 days
VARC defined "Time-related valve safety" composite endpoint
Time frame: From device implant to completion of at least 2 years of follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Background: PubMed 26189468Huczek 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.
- Background: PubMed 24431170Azmoun 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.
- Background: PubMed 23846009Schirmer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zenon Huczek, MD, PhD principal investigator
Medical University of Warsaw
Radosław Wilimski, MD principal investigator
Medical University of Warsaw
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis and Ventricular Outflow Obstruction, Left, run by Medical University of Warsaw at 6 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kajetan Grodecki (+48660675782, kajetan.grodecki@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VARC (Valve Academic Research Consortium-2) defined "Clinical Efficacy" composite endpoint (time frame: From 30 days post procedure to completion of at least 2 years of follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03361007, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.