Atrial Fibrillation Ablation Using PENTARAY CatheterNCT05101980
Predictors of Atrial Fibrillation Recurrence After Ablation Using PENTARAY Catheter
An observational study of Atrial Fibrillation Ablation Using PENTARAY Catheter, run by Assiut University.
Trial summary
CARTO represent a new way of 3D electroanaromic mapping for AF which has improved safety and success rate of AF ablation compared with other conventional methods of AF ablation as it provide accurate visualization of atrial anatomy and identification of atrial substrate properties for catheter ablation of atrial… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation Ablation Using PENTARAY Catheter
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 30 Mar 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with paroxismal AF who are eligible for AF ablation
Who may be able to join
- Patient with paroxismal AF who are eligible for AF ablation
- Patient resistant to medical treatment
Who cannot join
- Patient with other types of arrythmias
- Patient with prothetic valves
- Patient with valvular AF
About this study
CARTO represent a new way of 3D electroanaromic mapping for AF which has improved safety and success rate of AF ablation compared with other conventional methods of AF ablation as it provide accurate visualization of atrial anatomy and identification of atrial substrate properties for catheter ablation of atrial arrythmias which ensure good ablation with decreased incidence of recurrence of AF.
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintenance of sinus rhythm after successful ablation of atrial fibrillation
Measured: 6 months after AF ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start1 Dec 2021 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation Ablation Using PENTARAY CatheterStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Hamdy Bassit, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05101980
- Sponsor's protocol ID
- PENTARAY catheter
- Status last verified
- Nov 2021
- First submitted
- 20 Oct 2021
- Last updated
- 29 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Atrial Fibrillation Recurrence After Ablation Using PENTARAY Catheter
- ClinicalTrials.gov ID
- NCT05101980
- Acronym / sponsor ID
- PENTARAY catheter
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 1 Nov 2021 (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.
CARTO represent a new way of 3D electroanaromic mapping for AF which has improved safety and success rate of AF ablation compared with other conventional methods of AF ablation as it provide accurate visualization of atrial anatomy and identification of atrial substrate properties for catheter ablation of atrial arrythmias which ensure good ablation with decreased incidence of recurrence of AF.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with paroxismal AF who are eligible for AF ablation
Key inclusion criteria (2 listed)
- Patient with paroxismal AF who are eligible for AF ablation
- Patient resistant to medical treatment
Key exclusion criteria (3 listed)
- Patient with other types of arrythmias
- Patient with prothetic valves
- Patient with valvular AF
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
Maintenance of sinus rhythm after successful ablation of atrial fibrillation
Time frame: 6 months after AF ablation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2021.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation Ablation Using PENTARAY Catheter, run by Assiut University.
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 2 inclusion and 3 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 29 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Maintenance of sinus rhythm after successful ablation of atrial fibrillation (time frame: 6 months after AF ablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Nov 2021; AzTrials last refreshed its copy on 7 Nov 2026.