Ischemic Monomorphic Ventricular TachycardiaACE-VTNCT04841382
Physician Assessment of the Clinical Utility of a Patient-Specific 3D Electro-Anatomical Heart Model in VT Ablation
An observational study of Ischemic Monomorphic Ventricular Tachycardia, run by CardioSolv Ablation Technologies at 1 site in United States.
Trial summary
ACE-VT is a clinical pilot study designed to evaluate the ability of the CardioSolv Software System to generate an output for the physician to review in a timely fashion, consistent with the standard of care VT ablation workflow. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ischemic Monomorphic Ventricular Tachycardia
- What is being tested?
- Supporting information.
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 6 Oct 2022
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with monomorphic VT secondary to ischemic cardiomyopathy scheduled for a VT ablation procedure will be considered for enrollment.
Who may be able to join
- Participant meets standard criteria for VT ablation and is scheduled for VT ablation by their cardiologist or electrophysiologist
- 18 to 85 years of age
- VT and ischemic cardiomyopathy
- A pre-procedure MRI with LGE is available (performed within 1 year of procedure, unless an MI has occurred since MRI) with adequate image for analysis
- Participant is able and willing to provide written informed consent
Who cannot join
- Contradiction to MRI (except those with MRI compatible pacemaker/ICD/CRT devices implanted or site has approved procedure for MRI of non-compatible devices).
- Participant implanted with an LVAD.
- Enrolled in another non-imaging intervention assignment study that could confound the results of this study.
Trial locations and contacts
1 site in 1 country.
About this study
ACE-VT is a clinical pilot study designed to evaluate the ability of the CardioSolv Software System to generate an output for the physician to review in a timely fashion, consistent with the standard of care VT ablation workflow. This study will assess the acute effectiveness of using the CardioSolv Software System output as additional supporting information during ablation.
- Being tested
- Supporting information.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supporting information.Other
CardioSolv Software System is a software-based medical device meant which creates a patient-specific 3D heart model that provides physiologic information.
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Receipt of 3D Heart Model
Verify that the CardioSolv Software System is able to receive and process input data and generate the expected output available for viewing by the physician in less than 24 hours.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start1 Jun 2021
- Primary completion6 Oct 2022
- Study completion6 Oct 2022
Why it stopped: Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Monomorphic Ventricular TachycardiaStudies of the same condition, open and under way.
- 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- CardioSolv Ablation Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Saman Nazarian, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841382
- Sponsor's protocol ID
- REDD-0018
- Acronym
- ACE-VT
- Status last verified
- Oct 2022
- First submitted
- 8 Apr 2021
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physician Assessment of the Clinical Utility of a Patient-Specific 3D Electro-Anatomical Heart Model in VT Ablation
- ClinicalTrials.gov ID
- NCT04841382
- Acronym / sponsor ID
- ACE-VT / REDD-0018
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor
- Enrolment
- 1 participants (actual)
- Lead sponsor
- CardioSolv Ablation TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 6 Oct 2022 (actual)
- Study completion
- 6 Oct 2022 (actual)
- First posted
- 12 Apr 2021 (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.
ACE-VT is a clinical pilot study designed to evaluate the ability of the CardioSolv Software System to generate an output for the physician to review in a timely fashion, consistent with the standard of care VT ablation workflow. This study will assess the acute effectiveness of using the CardioSolv Software System output as additional supporting information during ablation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with monomorphic VT secondary to ischemic cardiomyopathy scheduled for a VT ablation procedure will be considered for enrollment.
Key inclusion criteria (5 listed)
- Participant meets standard criteria for VT ablation and is scheduled for VT ablation by their cardiologist or electrophysiologist
- 18 to 85 years of age
- VT and ischemic cardiomyopathy
- A pre-procedure MRI with LGE is available (performed within 1 year of procedure, unless an MI has occurred since MRI) with adequate image for analysis
- Participant is able and willing to provide written informed consent
Key exclusion criteria (3 listed)
- Contradiction to MRI (except those with MRI compatible pacemaker/ICD/CRT devices implanted or site has approved procedure for MRI of non-compatible devices).
- Participant implanted with an LVAD.
- Enrolled in another non-imaging intervention assignment study that could confound the results of this study.
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 |
|---|---|---|
| Supporting information.CardioSolv Software System is a software-based medical device meant which creates a patient-specific 3D heart model that provides physiologic information. | Other | – |
Primary outcome
Time to Receipt of 3D Heart Model
Time frame: 24 hours
Verify that the CardioSolv Software System is able to receive and process input data and generate the expected output available for viewing by the physician in less than 24 hours.
Results and safety
The study was stopped early (reason given: Sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
- Individual participant dataSharing planned: Undecided
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.
Saman Nazarian, MD principal investigator
University of Pennsylvania
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 Ischemic Monomorphic Ventricular Tachycardia, run by CardioSolv Ablation Technologies at 1 site in United States.
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 5 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: stopped early, as of the sponsor's last update on 19 Oct 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 United States. 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?
The study was stopped early (reason given: Sponsor). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Receipt of 3D Heart Model (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2022; AzTrials last refreshed its copy on 8 Nov 2026.