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

NCT05314218 | Completed

• 1 other identifier: 2045-CIP_v1_01Feb2022
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cardiac Arrhythmia

Outcome Measures

Primary Outcomes (1)

• Signal quality

  Good signal amplitude and signal stability throughout the procedure without artefact

  Through study completion, an average of 4 hours

Secondary Outcomes (5)

• Micro-stimulation

  Through study completion, an average of 4 hours

• Manoeuvrability

  Through study completion, an average of 4 hours

• Bending

  Through study completion, an average of 4 hours

• Imaging

  Through study completion, an average of 4 hours

• Diagnosis

  Through study completion, an average of 4 hours

Interventions

Electrophysiology catheters and cables DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• To be included, patients must be:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alcis: lead

Study Sites (2)

Clinique Rhône Durance

Avignon, 84000, France

Location

Hôpital Henri-Mondor AP-HP

Créteil, Île-de-France Region, 94000, France

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: April 6, 2022
• Study Start: May 23, 2022
• Primary Completion: May 25, 2023
• Study Completion: May 26, 2023
• Last Updated: June 13, 2023

Record last verified: 2023-06

Locations

FR (2)