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

June 12, 2023 updated by: Alcis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

168

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Avignon, France, 84000
        • Clinique Rhône Durance
    • Ile De France
      • Créteil, Ile De France, France, 94000
        • Hôpital Henri-Mondor AP-HP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients who have to undergo diagnostic procedure or ablation procedure (Cardiac arrythmias).

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Signal quality
Time Frame: Through study completion, an average of 4 hours
Good signal amplitude and signal stability throughout the procedure without artefact
Through study completion, an average of 4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Micro-stimulation
Time Frame: Through study completion, an average of 4 hours
Micro-stimulation worked well.
Through study completion, an average of 4 hours
Manoeuvrability
Time Frame: Through study completion, an average of 4 hours
Ease of positioning and manoeuvrability the catheter (access to the desired area)
Through study completion, an average of 4 hours
Bending
Time Frame: Through study completion, an average of 4 hours
Link between the wheel and the bending for dynamic Xtrem and bending stability
Through study completion, an average of 4 hours
Imaging
Time Frame: Through study completion, an average of 4 hours
Visibility via X ray or 3D navigation.
Through study completion, an average of 4 hours
Diagnosis
Time Frame: Through study completion, an average of 4 hours
Diagnosis efficiency
Through study completion, an average of 4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2022

Primary Completion (Actual)

May 25, 2023

Study Completion (Actual)

May 26, 2023

Study Registration Dates

First Submitted

March 29, 2022

First Submitted That Met QC Criteria

April 5, 2022

First Posted (Actual)

April 6, 2022

Study Record Updates

Last Update Posted (Estimated)

June 13, 2023

Last Update Submitted That Met QC Criteria

June 12, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2045-CIP_v1_01Feb2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe