Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05781282
Other study ID # 3747
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date November 1, 2021
Est. completion date June 1, 2024

Study information

Verified date March 2023
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact Gianluigi Bencardino, Dr
Phone +039 0630154187
Email gianluigi.bencardino@policlinicogemelli.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To test the hypothesis that structural changes documented by ICE after pulmonary vein deconnection by RF can predict AF recurrences


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


Recruitment information / eligibility

Status Recruiting
Enrollment 18
Est. completion date June 1, 2024
Est. primary completion date January 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Atrial fibrillation ablation candidates Exclusion Criteria: - Previous catheter ablation - Persistent atrial fibrillation

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Atrial fibrillation ablation
Pulmonary vein deconnection. PV antra visualization by ICE

Locations

Country Name City State
Italy Fondazione Policlinico Agostino Gemelli Roma IRCCS Roma

Sponsors (1)

Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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 th — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Atrial fibrillation recurrences Recurrences of atrial fibrillation at 12 months follow up despite pulmonary vein deconnection 12 months
See also
  Status Clinical Trial Phase
Recruiting NCT05266144 - Atrial Fibrillation Patients Treated With Catheter Ablation
Recruiting NCT06202209 - The Impact of Autonomic Function on Atrial Fibrillation Recurrence After Pulmonary Vein Ablation
Not yet recruiting NCT04780438 - Dapagliflozin to Prevent Atrial Fibrillation Recurrence After Transcatheter Pulmonary Venous Isolation. Early Phase 1
Not yet recruiting NCT06098989 - A Prospective Study of REPeat Ablation In Patients With Recurrent PERSistent Atrial Fibrillation: Pulmonary Vein Isolation vs. Adjunct Posterior Wall Isolation (REPAIR PERS-AF Study) N/A
Terminated NCT04704050 - Effect of Dronedarone on Atrial Fibrosis Progression and Atrial Fibrillation Recurrence Phase 4
Recruiting NCT04968678 - Exploring P-Wave Duration in Arrhythmia Recurrence in Patients Undergoing AF Ablation
Completed NCT04964440 - Redo AF Sub Study (of the Pure EP 2.0 Main Study)
Not yet recruiting NCT06204640 - SPironolactONe for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation Phase 3
Recruiting NCT06253000 - Radiofrequency and Cryoablation of the Posterior Wall of the Left Atrium N/A
Not yet recruiting NCT06199180 - Pulsed Field Ablation Versus Conventional Radiofrequency Catheter Ablation for Repeat PVI in Patients With Paroxysmal AF N/A
Recruiting NCT03075930 - Atrial Fibrillation Ablation Registry
Recruiting NCT05528419 - Sacubitril Valsartan in Preventing the Recurrence of Atrial Fibrillation After Ablation in Elderly Hypertensive Patients With Atrial Fibrillation Phase 4
Not yet recruiting NCT06130358 - Investigating the Effects of a Museum Intervention on the Psychological and Cardiac Health of Older Adults N/A
Completed NCT05486364 - DIGITal mOnitoring afTer Af abLation N/A
Recruiting NCT05159180 - Development of a New Impedance Mapping System for Ablation of Atrial Arrhythmias in Patients
Active, not recruiting NCT06111443 - Effect of Dapagliflozin on the Recurrence of Atrial Tachyarrhythmia in Patients Undergoing Catheter Ablation of Atrial Fibrillation Phase 2/Phase 3