Cardiac ArrhythmiaNCT06482840

Safety and Efficacy of EasyCool Catheter

An observational study of Cardiac Arrhythmia, run by MedFact Engineering GmbH at 1 site in Tunisia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial 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. Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Cardiac Arrhythmia
How many people: 15 participants
Where: 1 siteTunisia
Study dates: 8 Dec 2023to Aug 2024
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 years and older
All sexes
Child, Adult, Older adult

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.

Who may be able to join

Patients requiring intracardial RF- Ablation with irrigated catheter

Who cannot join

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;

Show all 18Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Tunisia1 site

Centre Hospitalier International de Carthagène
Tunis, Centre Urbain Nord, 1082

Other trials in Tunisia

About this study

Official title: Safety and Efficacy of EasyCool Catheter - Prospective Monocentric Study

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
Medical subject headings: Arrhythmias, Cardiac

What is being measured

The primary outcome is the main question the study is designed to answer.

Removal of treated cardiac arrythmia
Removal of treated cardiac arrhythmia and absence of recurrence of the arrythmia
Measured: 3 months after procedure

Secondary outcomes (1)

Adverse Events
all adverse events in context to procedure and product
Measured: at procedure, after 3 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Dec 2023Aug 2024

First posted1 Jul 2024
Study start8 Dec 2023
Primary completion30 May 2024
Study completionAug 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cardiac ArrhythmiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06482840
Sponsor's protocol ID: CT04-01_EasyCool
Status last verified: Jun 2024
First submitted: 26 Jun 2024
Last updated: 1 Jul 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
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nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Enrolling by invitation
EDEN Intracardiac Electrogram Recording and Classifying System
Ventricular Arrhythmia

All Cardiac Arrhythmia trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of EasyCool Catheter - Prospective Monocentric Study
ClinicalTrials.gov ID: NCT06482840
Acronym / sponsor ID: CT04-01_EasyCool
Conditions: Cardiac Arrhythmia
Keywords: EasyCool Catheter, cardiac ablation
Study type: Observational
Recruitment status: Unknown status
Enrolment: 15 participants (actual)
Lead sponsor: MedFact Engineering GmbHIndustry (pharma, biotech, devices)
Study start: 8 Dec 2023 (actual)
Primary completion: 30 May 2024 (actual)
Study completion: Aug 2024 (estimated)
First posted: 1 Jul 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 12 years and older
Sex: All
Age groups: Child, Adult, Older adult
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.

Key inclusion criteria (1 listed)

Patients requiring intracardial RF- Ablation with irrigated catheter

Key exclusion criteria (18 listed)

Absence of patient´s consent;
Age <12 years;
Pregnancy or breast-feeding women;
Acute local infection;
Acute systemic infection;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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

1 secondary outcome

Adverse Events
Time frame: at procedure, after 3 and 6 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.

Related trials for Cardiac Arrhythmia

RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Enrolling by invitation
EDEN Intracardiac Electrogram Recording and Classifying System
Ventricular Arrhythmia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Abdeddayem Haggui, Prof principal investigator

Centre Hospitalier International de Carthagène, Tunisia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiac Arrhythmia, run by MedFact Engineering GmbH at 1 site in Tunisia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Removal of treated cardiac arrythmia (time frame: 3 months after procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06482840.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.