Aortic Valve StenosisPRECISE_TAVINCT04473443
Addition of Computer Simulations to Minimize Adverse Events After Transcatheter Aortic Valve Implantation
An observational study of Aortic Valve Stenosis and Bicuspid Cardiac Valve, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
The objective is to assess the influence of FEops HEARTguide on overall device success in TAVI patients with challenging anatomies (Cohort A) or in transcatheter heart valve (THV) platform selection (Cohort B). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Bicuspid Cardiac Valve
- What is being tested?
- FEops HEARTguideTM
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Aug 2020to 30 Jun 2023
- 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: This prospective multi-center international Registry of TAVI patients include for Cohort A patients with the following complex anatomy: BAV (Sievers 0 or 1) or functional bicuspid aortic valves, severely calcified aortic valve and small aortic roots. And for Cohort B consecutive patients eligible for TAVI with ACURATE-NEO2-valve
Who may be able to join
- Cohort A:
- Patients with a Bicuspid Aortic Valve (Sievers 0 or 1) or functional Bicuspid Aortic Valve
- Patients with a severely calcified aortic valve (Agatston score > 3000 for men, and > 1600 for women)
- Patients with small anatomy defined by mean aortic annulus diameter < 20mm
- Cohort B:
- every patient accepted for TAVI and eligible for ACURATE-NEO2-valve.
Who cannot join
- poor CT quality
- previous aortic valve replacement
- Permanent pacemaker at baseline
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus Medical Center
Rotterdam, 3015GD
Nicolas van Mieghem, MD, PhD, +31(0)107035260, n.vanmieghem@erasmusmc.nl
About this study
Official title: Addition of Computer Simulations to the Pre-procedural Planning to Minimize Adverse Events After Transcatheter Aortic Valve Implantation
The objective is to assess the influence of FEops HEARTguide on overall device success in TAVI patients with challenging anatomies (Cohort A) or in transcatheter heart valve (THV) platform selection (Cohort B).
Read the detailed description
Rationale Transcatheter aortic valve implantation (TAVI) is increasingly used to treat patients with severe aortic stenosis. However, by extending the indication for TAVI, simulation may become increasingly important to improve procedure execution, safety and efficacy.
Objective Assess the influence of FEops HEARTguideTM on overall device success in challenging anatomies (Cohort A) or in transcatheter heart valve (THV) platform selection (Cohort B).
Study design Prospective, observational multi-center trial with 2 cohorts.
Study population
- Cohort A: patients with challenging anatomy undergoing EvolutTM TAVI (Medtronic, Minneapolis, Minnesota), to evaluate the influence of FEops HeartGuideTM on overall device success through valve size and implantation depth.
- Cohort B: consecutive patients, eligible for TAVI with ACURATE NEO2 TM (Boston Scientific, Marlborough, Massachusetts) to evaluate the influence of FEops heartGuideTM on overall device success and PVL prediction.
Main Endpoints
- Overall device success conform VARC-2 including need for new permanent pacemaker. 2. Incidence of > trivial Paravalvular leakage (PVL) 3. Need for new permanent pacemaker
- Conditions
- Aortic Valve Stenosis, Bicuspid Cardiac Valve
- Being tested
- FEops HEARTguideTM
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FEops HEARTguideTMOther
A patient-specific computer simulation that aims to improve the outcomes after TAVI by suggesting THV platform, THV size and implantation depth with the use of the pre-procedural CT-scan.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Patients with a challenging anatomy, including bicuspid aortic valve, severely calcified aortic valves or small aortic roots Receives: Other: FEops HEARTguideTM | |
| Cohort B | Consecutive patients eligible for TAVI with ACURATE-NEO2 valve Receives: Other: FEops HEARTguideTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall device success conform the VARC-2 document
- Incidence of mortality
- incidence of stroke
- incidence of major vascular complication
- incidence of life-threatening bleeding
Measured: 30 days after TAVI
Secondary outcomes (2)
incidence of more than trivial PVL
total incidence of trivial PVL
Measured: 30 days after TAVI
conduction abnormalities and need for new permanent pacemaker implantation
- incidence of new permanent pacemaker implantations
- incidence of left bundle branch block
- incidence of total AV block
Measured: 30 days after TAVI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start1 Aug 2020
- Primary completion1 Feb 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Erasmus Medical CenterThe 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)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Feops
- Responsible party
- Principal investigator, Nicolas van Mieghem, Erasmus Medical Center
- Investigators
- Nicolas van Mieghem, Md,PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473443
- Sponsor's protocol ID
- PRECISE TAVI
- Acronym
- PRECISE_TAVI
- Status last verified
- Jul 2022
- First submitted
- 13 Jul 2020
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB; Valve Academic Research Consortium-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Thorac Cardiovasc Surg. 2013 Jan;145(1):6-23. doi: 10.1016/j.jtcvs.2012.09.002. Epub 2012 Oct 16.
PubMed 23084102
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addition of Computer Simulations to the Pre-procedural Planning to Minimize Adverse Events After Transcatheter Aortic Valve Implantation
- ClinicalTrials.gov ID
- NCT04473443
- Acronym / sponsor ID
- PRECISE_TAVI / PRECISE TAVI
- Conditions
- Aortic Valve Stenosis, Bicuspid Cardiac Valve
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Feops
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 16 Jul 2020 (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.
The objective is to assess the influence of FEops HEARTguide on overall device success in TAVI patients with challenging anatomies (Cohort A) or in transcatheter heart valve (THV) platform selection (Cohort B).
Detailed description
Rationale Transcatheter aortic valve implantation (TAVI) is increasingly used to treat patients with severe aortic stenosis. However, by extending the indication for TAVI, simulation may become increasingly important to improve procedure execution, safety and efficacy.
Objective Assess the influence of FEops HEARTguideTM on overall device success in challenging anatomies (Cohort A) or in transcatheter heart valve (THV) platform selection (Cohort B).
Study design Prospective, observational multi-center trial with 2 cohorts.
Study population
- Cohort A: patients with challenging anatomy undergoing EvolutTM TAVI (Medtronic, Minneapolis, Minnesota), to evaluate the influence of FEops HeartGuideTM on overall device success through valve size and implantation depth.
- Cohort B: consecutive patients, eligible for TAVI with ACURATE NEO2 TM (Boston Scientific, Marlborough, Massachusetts) to evaluate the influence of FEops heartGuideTM on overall device success and PVL prediction.
Main Endpoints
- Overall device success conform VARC-2 including need for new permanent pacemaker. 2. Incidence of > trivial Paravalvular leakage (PVL) 3. Need for new permanent pacemaker
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Other: FEops HEARTguideTMPatients with a challenging anatomy, including bicuspid aortic valve, severely calcified aortic valves or small aortic roots |
| Cohort B | – | Other: FEops HEARTguideTMConsecutive patients eligible for TAVI with ACURATE-NEO2 valve |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This prospective multi-center international Registry of TAVI patients include for Cohort A patients with the following complex anatomy: BAV (Sievers 0 or 1) or functional bicuspid aortic valves, severely calcified aortic valve and small aortic roots. And for Cohort B consecutive patients eligible for TAVI with ACURATE-NEO2-valve
Key inclusion criteria (6 listed)
- Cohort A:
- Cohort B:
Key exclusion criteria (3 listed)
- poor CT quality
- previous aortic valve replacement
- Permanent pacemaker at baseline
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 |
|---|---|---|
| FEops HEARTguideTMA patient-specific computer simulation that aims to improve the outcomes after TAVI by suggesting THV platform, THV size and implantation depth with the use of the pre-procedural CT-scan. | Other | Cohort A, Cohort B |
Primary outcome
overall device success conform the VARC-2 document
Time frame: 30 days after TAVI
* Incidence of mortality * incidence of stroke * incidence of major vascular complication * incidence of life-threatening bleeding
2 secondary outcomes
incidence of more than trivial PVL
Time frame: 30 days after TAVI
conduction abnormalities and need for new permanent pacemaker implantation
Time frame: 30 days after TAVI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Background: PubMed 23084102Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB; Valve Academic Research Consortium-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Thorac Cardiovasc Surg. 2013 Jan;145(1):6-23. doi: 10.1016/j.jtcvs.2012.09.002. Epub 2012 Oct 16.
- Individual participant dataSharing planned: Undecided
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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.
Nicolas van Mieghem, Md,PhD principal investigator
Erasmus Medical Center
1 site 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 Bicuspid Cardiac Valve, run by Erasmus Medical Center at 1 site in Netherlands.
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 6 inclusion and 3 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 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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 Nicolas van Mieghem, MD, PhD (+31107035260, n.vanmieghem@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall device success conform the VARC-2 document (time frame: 30 days after TAVI). 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 NCT04473443, which also lists 1 linked publication.
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 27 Jul 2022.