Atrial Fibrillation Recurrent Clinical Trial
Official title:
Pulmonary Vein Imaging by ICE After Atrial Fibrillation Ablation to Predict Recurrences
| 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 |
To test the hypothesis that structural changes documented by ICE after pulmonary vein deconnection by RF can predict AF recurrences
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Fondazione Policlinico Agostino Gemelli Roma IRCCS | Roma |
| Lead Sponsor | Collaborator |
|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Italy,
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
| 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 |
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