Safety and Efficacy of EasyCool Catheter

Safety and Efficacy of EasyCool Catheter - Prospective Monocentric Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06482840

Enrollment

Registered

2024-07-01

Start date

2023-12-08

Completion date

2024-08-31

Last updated

2024-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrhythmia

Keywords

EasyCool Catheter, cardiac ablation

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Removal of treated cardiac arrythmia	3 months after procedure	Removal of treated cardiac arrhythmia and absence of recurrence of the arrythmia

Secondary

Measure	Time frame	Description
Adverse Events	at procedure, after 3 and 6 months	all adverse events in context to procedure and product

Countries

Tunisia

Outcome results