Safety and Efficacy of EasyCool Catheter

NCT06482840 | Active Not Recruiting

• 1 other identifier: CT04-01_EasyCool
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about risks and benefit of EasyCool Catheter for cardiovascular ablation in real-world patients suffering from cardiac arrythmias. The main question\[s\] it aims to answer are:

• will the cardiac arrythmia be removed and remain absent oc recurrent also 3 months after procedure
• what are the adverse events at procedure, after 3 and 6 months All participants will receive cardiac ablation with EasyCool catheter.

Conditions

Cardiac Arrhythmia

Keywords

EasyCool Catheter; cardiac ablation

Outcome Measures

Primary Outcomes (1)

• Removal of treated cardiac arrythmia

  Removal of treated cardiac arrhythmia and absence of recurrence of the arrythmia

  3 months after procedure

Secondary Outcomes (1)

• Adverse Events

  at procedure, after 3 and 6 months

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Intracardial RF-Ablation procedure at following indications: * Atrial Tachycardia * Tricuspid istmus flutter * Atypical flutter * Focal atrial tachycardia * Atrial fibrillation * AV-node re-entrant tachycardia; * Tachycardia heart rhythm disturbances associated with accessory pathways; * Ventricular Tachycardia.

You may qualify if:

• Patients requiring intracardial RF- Ablation with irrigated catheter

You may not qualify if:

• Absence of patient´s consent;
• Age \<12 years;
• Pregnancy or breast-feeding women;
• Acute local infection;
• Acute systemic infection;
• Atrial thrombosis or myxoma - the transseptal approach is contraindicated in patients with left atrial thrombus;
• Existence of active Implants (Pacemaker, Defibrillator etc.);
• Hemodynamic instability;
• Hypercoagulability;
• Inadequate tissue damaged e.g. by radiation or suppuration;
• Obstruction of the artery or vein selected for insertion;
• Patients with artificial heart valve: the use of intracardial catheters is not advised;
• Physiologic or anatomic abnormalities that could cause postoperative complications e.g. aneurysms in the application area, bleeding diathesis, decreased resistance to infections;
• Previously diagnosed spasms of the coronary arteries;
• Recurrent metastasizing cancer;

Sponsors & Collaborators

• MedFact Engineering GmbH: lead

Study Sites (1)

Centre Hospitalier International de Carthagène

Tunis, Centre Urbain Nord, 1082, Tunisia

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

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

Study Officials

• Abdeddayem Haggui, Prof

  Centre Hospitalier International de Carthagène, Tunisia

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 1, 2024
• Study Start: December 8, 2023
• Primary Completion: May 30, 2024
• Study Completion: August 1, 2024
• Last Updated: July 1, 2024

Record last verified: 2024-06

Locations

TU (1)