Ventricular TachycardiaEPINAVNCT04171479
RMN Versus Manual Epicardial Retrospective PMCF
An observational study of Ventricular Tachycardia and Premature Ventricular Contraction, run by Stereotaxis at 3 sites in 2 countries.
Trial summary
Retrospective registry will compare subjects who've undergone a mapping and/or ablation procedure for either ischemic ventricular tachycardia or premature ventricular contraction using an epicardial approach with either manual or remote magnetic navigation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia, Premature Ventricular Contraction
- What is being tested?
- Epicardial mapping and/or ablation
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 2 Oct 2020to 30 Mar 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
- Adult, Older adult
Study population: Subjects who have undergone an epicardial cardiac mapping and ablation procedure using either manual or remote magnetic (using Stereotaxis Niobe system) guidance.
Who may be able to join
- 18 years of age or older
- Have undergone an epicardial RF mapping and/or ablation for a ventricular tachycardia (VT) as standard of care treatment using either the Niobe MNS or a manual approach
- Index procedure was conducted between July 1, 2013-present date.
Who cannot join
- NA, all subjects who meet inclusion criteria may be enrolled.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Netherlands2 sites
OLVG Hospital
Amsterdam
Erasmus Medical Center
Rotterdam
About this study
Official title: A Retrospective Multicenter Post-Market Clinical Follow-up Registry Comparing Safety and Effectiveness Outcomes of Epicardial Cardiac Ablation Using Remote Navigation to Manual Techniques
Retrospective registry will compare subjects who've undergone a mapping and/or ablation procedure for either ischemic ventricular tachycardia or premature ventricular contraction using an epicardial approach with either manual or remote magnetic navigation. Subjects will be compared with regards to safety, efficacy and mortality.
Read the detailed description
Up to 10 centers in the European Union will be selected to conduct the trial. Once a site is a selected, receives local Ethics Committee approval, and receives Sponsor approval to enroll, the site will begin enrollment. All subjects must meet eligibility criteria and follow protocol and ethics committee requirements regarding informed consent prior to enrollment. Once a subject is enrolled, the site may begin reviewing the subject's medical records and entering data into the electronic data capture system. Once enrollment and retrospective data entry is complete at a site, a monitoring visit will occur where source data verification will occur.
- Being tested
- Epicardial mapping and/or ablation
- Medical subject headings
- Tachycardia, Ventricular, Ventricular Premature Complexes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epicardial mapping and/or ablationDevice
Either catheter mapping, ablation, or mapping and ablation will be performed using an epicardial catheter approach.
| Study group | Role | What they receive |
|---|---|---|
| Manual | Subjects who underwent epicardial mapping and/or ablation using a manual technique will comprise this group. Receives: Device: Epicardial mapping and/or ablation | |
| Remote Magnetic Navigation | Subjects who underwent epicardial mapping and/or ablation using a remote magnetic technique (using Stereotaxis Niobe system) will comprise this group. Receives: Device: Epicardial mapping and/or ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Success
Characterize acute success rates for both groups. Acute success for VT procedures is defined as non-inducibility of clinical VT and/or other monomorphic VT at the end of the index-procedure. Acute success for PVC procedures is defined as no recurrence and non-inducibility of culprit PVC at the end of the index-procedure.
Measured: intra-operative
Procedural Safety: rates of device-and procedure-related serious adverse events
Assess rates of device-and procedure-related serious adverse events in both groups.
Measured: 48 hours post index procedure
Secondary outcomes (5)
Chronic Success
Characterize recurrence rates for both groups at 1 year post index procedure.
Measured: 1 year post index procedure
Chronic Safety: rates of device-or procedure-related serious adverse events
Characterize rates of device-or procedure-related serious adverse events for both groups at 1 year post index procedure.
Measured: 1 year post index procedure
Mortality
Assess mortality rate for both groups
Measured: 1 year post index procedure
Chronic Success
Characterize recurrence rates for both groups at last follow up.
Measured: At last follow up visit, estimated up to 6 years post-procedure for some patients
Chronic Safety: rates of device-or procedure-related serious adverse events
Characterize rates of device-or procedure-related serious adverse events for both groups at last follow up.
Measured: At last follow up visit, estimated up to 6 years post-procedure for some patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start2 Oct 2020
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stereotaxis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171479
- Sponsor's protocol ID
- CLIN-024
- Acronym
- EPINAV
- Status last verified
- Aug 2023
- First submitted
- 30 Apr 2019
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Multicenter Post-Market Clinical Follow-up Registry Comparing Safety and Effectiveness Outcomes of Epicardial Cardiac Ablation Using Remote Navigation to Manual Techniques
- ClinicalTrials.gov ID
- NCT04171479
- Acronym / sponsor ID
- EPINAV / CLIN-024
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- StereotaxisIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2020 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 21 Nov 2019 (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.
Retrospective registry will compare subjects who've undergone a mapping and/or ablation procedure for either ischemic ventricular tachycardia or premature ventricular contraction using an epicardial approach with either manual or remote magnetic navigation. Subjects will be compared with regards to safety, efficacy and mortality.
Detailed description
Up to 10 centers in the European Union will be selected to conduct the trial. Once a site is a selected, receives local Ethics Committee approval, and receives Sponsor approval to enroll, the site will begin enrollment. All subjects must meet eligibility criteria and follow protocol and ethics committee requirements regarding informed consent prior to enrollment. Once a subject is enrolled, the site may begin reviewing the subject's medical records and entering data into the electronic data capture system. Once enrollment and retrospective data entry is complete at a site, a monitoring visit will occur where source data verification will occur.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual | – | Device: Epicardial mapping and/or ablationSubjects who underwent epicardial mapping and/or ablation using a manual technique will comprise this group. |
| Remote Magnetic Navigation | – | Device: Epicardial mapping and/or ablationSubjects who underwent epicardial mapping and/or ablation using a remote magnetic technique (using Stereotaxis Niobe system) will comprise this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects who have undergone an epicardial cardiac mapping and ablation procedure using either manual or remote magnetic (using Stereotaxis Niobe system) guidance.
Key inclusion criteria (3 listed)
- 18 years of age or older
- Have undergone an epicardial RF mapping and/or ablation for a ventricular tachycardia (VT) as standard of care treatment using either the Niobe MNS or a manual approach
- Index procedure was conducted between July 1, 2013-present date.
Key exclusion criteria (1 listed)
- NA, all subjects who meet inclusion criteria may be enrolled.
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 |
|---|---|---|
| Epicardial mapping and/or ablationEither catheter mapping, ablation, or mapping and ablation will be performed using an epicardial catheter approach. | Device | Manual, Remote Magnetic Navigation |
Primary outcome
Acute Success
Time frame: intra-operative
Characterize acute success rates for both groups. Acute success for VT procedures is defined as non-inducibility of clinical VT and/or other monomorphic VT at the end of the index-procedure. Acute success for PVC procedures is defined as no recurrence and non-inducibility of culprit PVC at the end of the index-procedure.
Procedural Safety: rates of device-and procedure-related serious adverse events
Time frame: 48 hours post index procedure
Assess rates of device-and procedure-related serious adverse events in both groups.
5 secondary outcomes
Chronic Success
Time frame: 1 year post index procedure
Chronic Safety: rates of device-or procedure-related serious adverse events
Time frame: 1 year post index procedure
Mortality
Time frame: 1 year post index procedure
Chronic Success
Time frame: At last follow up visit, estimated up to 6 years post-procedure for some patients
Chronic Safety: rates of device-or procedure-related serious adverse events
Time frame: At last follow up visit, estimated up to 6 years post-procedure for some patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Tachycardia and Premature Ventricular Contraction, run by Stereotaxis at 3 sites in 2 countries.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands, Czechia. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Acute Success (time frame: intra-operative). The study lists 2 primary outcomes in all. 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 3 Aug 2023.