Cardiac ArrhythmiaNCT05314218
The Objective of This Multicentre Study is to Collect Operative Data on the Related Clinical Functional Outcomes and Complications and of Market Approved Alcis Electrophysiology Catheters to Demonstrate Safety and Performance of These Devices in a Real-world Setting
An observational study of Cardiac Arrhythmia, run by Alcis at 2 sites in France.
Trial summary
The objective of this multicentre study is to collect operative data on the related clinical functional outcomes and complications and of market approved Alcis electrophysiology catheters to demonstrate safety and performance of these devices in a real-world setting. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cardiac Arrhythmia
- What is being tested?
- Electrophysiology catheters and cables
- Type of treatment
- Medical device
- How many people
- 168 participants
- Where
- 2 sitesFrance
- Study dates
- 23 May 2022to 26 May 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have to undergo diagnostic procedure or ablation procedure (Cardiac arrythmias).
Who may be able to join
- To be included, patients must be:
- 18 to 90 years old
- Patient who have to undergo diagnostic procedure or ablation procedure (Cardiac arrythmias)
- Informed and willing to sign an informed consent for approved by EC
- Affiliation to the social security or foreign regime recognized in France
Who cannot join
- A patient will not be eligible to participate in the study if any of the following conditions are present:
- Not able to comply with the study procedures based on the judgment of the assessor (e.g. cannot comprehend study questions, inability to keep scheduled assessment times).
- Any medical condition that could impact the study at investigator's discretion (e.g. allergy…).
- Pregnant women
- Adult subject to legal protection measure
Trial locations and contacts
2 sites in 1 country.
France2 sites
Clinique Rhône Durance
Avignon, 84000
Hôpital Henri-Mondor AP-HP
Créteil, Île-de-France Region, 94000
About this study
Official title: EPICADIA - Electrophysiologic Performance Investigation for CArdiac DIAgnosis
The objective of this multicentre study is to collect operative data on the related clinical functional outcomes and complications and of market approved Alcis electrophysiology catheters to demonstrate safety and performance of these devices in a real-world setting.
Read the detailed description
Outcome data collected from this study will provide the basis for Post-Market Surveillance (PMS) reporting, Clinical Study Report (CSR), Clinical Evaluation Report (CER) on Alcis devices and support peer-reviewed publications on products performance and safety.
- Conditions
- Cardiac Arrhythmia
- Being tested
- Electrophysiology catheters and cables
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrophysiology catheters and cablesDevice
The Xtrem electrophysiology catheter was developed for diagnosis of cardiac arrhythmias. Their function is to collect by contact, electrical signals generated by the heart muscle.
Xtrem are inserted via femoral vena cava or via artery and can be used in two occasions:
- Exploration procedures for diagnosis alone
- Diagnosis before ablation procedure An extension cable is used to connect the catheter to a stimulation/ recording device.
What is being measured
The primary outcome is the main question the study is designed to answer.
Signal quality
Good signal amplitude and signal stability throughout the procedure without artefact
Measured: Through study completion, an average of 4 hours
Secondary outcomes (5)
Micro-stimulation
Micro-stimulation worked well.
Measured: Through study completion, an average of 4 hours
Manoeuvrability
Ease of positioning and manoeuvrability the catheter (access to the desired area)
Measured: Through study completion, an average of 4 hours
Bending
Link between the wheel and the bending for dynamic Xtrem and bending stability
Measured: Through study completion, an average of 4 hours
Imaging
Visibility via X ray or 3D navigation.
Measured: Through study completion, an average of 4 hours
Diagnosis
Diagnosis efficiency
Measured: Through study completion, an average of 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start23 May 2022
- Primary completion25 May 2023
- Study completion26 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrhythmiaStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314218
- Sponsor's protocol ID
- 2045-CIP_v1_01Feb2022
- Status last verified
- Jun 2023
- First submitted
- 29 Mar 2022
- Last updated
- 13 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EPICADIA - Electrophysiologic Performance Investigation for CArdiac DIAgnosis
- ClinicalTrials.gov ID
- NCT05314218
- Acronym / sponsor ID
- 2045-CIP_v1_01Feb2022
- Conditions
- Cardiac Arrhythmia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- AlcisIndustry (pharma, biotech, devices)
- Study start
- 23 May 2022 (actual)
- Primary completion
- 25 May 2023 (actual)
- Study completion
- 26 May 2023 (actual)
- First posted
- 6 Apr 2022 (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 of this multicentre study is to collect operative data on the related clinical functional outcomes and complications and of market approved Alcis electrophysiology catheters to demonstrate safety and performance of these devices in a real-world setting.
Detailed description
Outcome data collected from this study will provide the basis for Post-Market Surveillance (PMS) reporting, Clinical Study Report (CSR), Clinical Evaluation Report (CER) on Alcis devices and support peer-reviewed publications on products performance and safety.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have to undergo diagnostic procedure or ablation procedure (Cardiac arrythmias).
Key inclusion criteria (5 listed)
- 18 to 90 years old
- Patient who have to undergo diagnostic procedure or ablation procedure (Cardiac arrythmias)
- Informed and willing to sign an informed consent for approved by EC
- Affiliation to the social security or foreign regime recognized in France
Key exclusion criteria (5 listed)
- A patient will not be eligible to participate in the study if any of the following conditions are present:
- Not able to comply with the study procedures based on the judgment of the assessor (e.g. cannot comprehend study questions, inability to keep scheduled assessment times).
- Any medical condition that could impact the study at investigator's discretion (e.g. allergy…).
- Pregnant women
- Adult subject to legal protection measure
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 |
|---|---|---|
| Electrophysiology catheters and cablesThe Xtrem electrophysiology catheter was developed for diagnosis of cardiac arrhythmias. Their function is to collect by contact, electrical signals generated by the heart muscle. Xtrem are inserted via femoral vena cava or via artery and can be used in two occasions: * Exploration procedures for diagnosis alone * Diagnosis before ablation procedure An extension cable is used to connect the catheter to a stimulation/ recording device. | Device | – |
Primary outcome
Signal quality
Time frame: Through study completion, an average of 4 hours
Good signal amplitude and signal stability throughout the procedure without artefact
5 secondary outcomes
Micro-stimulation
Time frame: Through study completion, an average of 4 hours
Manoeuvrability
Time frame: Through study completion, an average of 4 hours
Bending
Time frame: Through study completion, an average of 4 hours
Imaging
Time frame: Through study completion, an average of 4 hours
Diagnosis
Time frame: Through study completion, an average of 4 hours
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 13 Jun 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrhythmia, run by Alcis at 2 sites in France.
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 5 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 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Signal quality (time frame: Through study completion, an average of 4 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 13 Jun 2023; AzTrials last refreshed its copy on 6 Nov 2026.