Safety and Efficacy of EasyCool Catheter

MedFact Engineering GmbH

Status: Active, not recruiting

Conditions: Cardiac Arrhythmia

Study type: Observational

Funder types: Industry

Identifiers

NCT06482840

CT04-01_EasyCool

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients requiring intracardial RF- Ablation with irrigated catheter

Exclusion criteria

• 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;
• Sepsis;
• Severe concomitant illness for which an increase or surgery time is associated with a significant increased risk;
• Thrombosis of the leg veins and the deep pelvic vein.