Safety and Efficacy of EasyCool Catheter

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-08

Study Completion Date

2024-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cardiac Arrhythmia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No