Atrial Fibrillation RecurrentPhase 4NCT05781282
Pulmonary Vein (PV) Imaging by Intracardiac Echography (ICE) After Ablation
A Phase 4 study testing Atrial fibrillation ablation in people with Atrial Fibrillation Recurrent, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
To test the hypothesis that structural changes documented by ICE after pulmonary vein deconnection by RF can predict AF recurrences Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation Recurrent
- What is being tested?
- Atrial fibrillation ablation
- Type of treatment
- Medical device
- How many people
- 18 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2021to 1 Jun 2024
- Phase
- Phase 4
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Atrial fibrillation ablation candidates
Who cannot join
- Previous catheter ablation
- Persistent atrial fibrillation
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Agostino Gemelli Roma IRCCS
Roma, 00168
Gianluigi Bencardino, gianluigi.bencardino@policlinicogemelli.it
About this study
Official title: Pulmonary Vein Imaging by ICE After Atrial Fibrillation Ablation to Predict Recurrences
To test the hypothesis that structural changes documented by ICE after pulmonary vein deconnection by RF can predict AF recurrences
Read the detailed description
Patient undergoing first RF ablation for sympomatic paroxysmal atrial fibrillation will be enrolled. ICE visualization of PV antra before and after PV deconnection (electrophysiological endpoint). Changes in echogenicity as documented by ICE will be evaluated by a dedicated software and correlated to long term recurrences
- Conditions
- Atrial Fibrillation Recurrent
- Being tested
- Atrial fibrillation ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atrial fibrillation ablationDevice
Pulmonary vein deconnection. PV antra visualization by ICE
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial fibrillation recurrences
Recurrences of atrial fibrillation at 12 months follow up despite pulmonary vein deconnection
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start1 Nov 2021
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation RecurrentStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bencardino Gianluigi, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Gianluigi Bencardino, Dr, Principal investigator, Fondazione Policlinico Agostino Gemelli Roma IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781282
- Sponsor's protocol ID
- 3747
- Status last verified
- Mar 2023
- First submitted
- 1 Mar 2023
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Leo M, De Maria GL, Briosa E Gala A, Pope M, Banerjee A, Kelion A, Pedersen M, Rajappan K, Ginks M, Bashir Y, Hunter RJ, Betts T. INtra-procedural ultraSound Imaging for DEtermination of atrial wall thickness and acute tissue changes after isolation of the pulmonary veins with radiofrequency, cryoballoon or laser balloon energy: the INSIDE PVs study. Int J Cardiovasc Imaging. 2021 Dec;37(12):3525-3535. doi: 10.1007/s10554-021-02417-7. Epub 2021 Sep 23.
PubMed 34554367
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Vein Imaging by ICE After Atrial Fibrillation Ablation to Predict Recurrences
- ClinicalTrials.gov ID
- NCT05781282
- Acronym / sponsor ID
- 3747
- Conditions
- Atrial Fibrillation Recurrent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 23 Mar 2023 (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.
To test the hypothesis that structural changes documented by ICE after pulmonary vein deconnection by RF can predict AF recurrences
Detailed description
Patient undergoing first RF ablation for sympomatic paroxysmal atrial fibrillation will be enrolled. ICE visualization of PV antra before and after PV deconnection (electrophysiological endpoint). Changes in echogenicity as documented by ICE will be evaluated by a dedicated software and correlated to long term recurrences
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Atrial fibrillation ablation candidates
Key exclusion criteria (2 listed)
- Previous catheter ablation
- Persistent atrial fibrillation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atrial fibrillation ablationPulmonary vein deconnection. PV antra visualization by ICE | Device | – |
Primary outcome
Atrial fibrillation recurrences
Time frame: 12 months
Recurrences of atrial fibrillation at 12 months follow up despite pulmonary vein deconnection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Results publication: PubMed 34554367Leo M, De Maria GL, Briosa E Gala A, Pope M, Banerjee A, Kelion A, Pedersen M, Rajappan K, Ginks M, Bashir Y, Hunter RJ, Betts T. INtra-procedural ultraSound Imaging for DEtermination of atrial wall thickness and acute tissue changes after isolation of the pulmonary veins with radiofrequency, cryoballoon or laser balloon energy: the INSIDE PVs study. Int J Cardiovasc Imaging. 2021 Dec;37(12):3525-3535. doi: 10.1007/s10554-021-02417-7. Epub 2021 Sep 23.
- Individual participant dataSharing planned: Undecided
Related trials for Atrial Fibrillation Recurrent
Not yet recruitingPhase 4
Sacubitril/Valsartan vs Standard Treatment for Preventing Atrial Fibrillation Recurrence After Catheter Ablation in Persistent Atrial Fibrillation Patients With Without Hypertension
Atrial Fibrillation (Persistent), Catheter Ablation
RecruitingObservational study
Atrial Fibrillation Patients Treated With Catheter Ablation
Atrial Fibrillation, Atrial Fibrillation Recurrent
RecruitingObservational study
BOdygUardian MOnitoriNg for ReCurrencE of AF
Atrial Fibrillation (AF)
Not yet recruiting
Mazdutide for Reducing Atrial Fibrillation Recurrence After Catheter Ablation in Obese Patients
Atrial Fibrillation (AF), Ablation Treatment
Active, not recruiting
The Effect of Low-Level Tragus Stimulation on Inflammation and Early Recurrence After Pulsed Field Ablation: A Randomized Controlled Study
Atrial Fibrillation
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.
Gianluigi Bencardino, Dr principal investigator
Fondazione Policlinico Agostino Gemelli Roma IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atrial fibrillation ablation in people with Atrial Fibrillation Recurrent, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 2 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 27 Mar 2023. 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 Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Gianluigi Bencardino, Dr (+039 0630154187, gianluigi.bencardino@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial fibrillation recurrences (time frame: 12 months). 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 NCT05781282, which also lists 1 linked publication.
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 27 Mar 2023.