Trials / Completed
CompletedNCT04293757
Rotational Angiography in Cryoballoon Ablation
Preprocedural Imaging by Rotational Angiography in Cryoballoon Ablation for Atrial Fibrillation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 128 (actual)
- Sponsor
- University of Zagreb · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
There is still unresolved question weather preprocedural imaging of left atrium and pulmonary veins is needed before the pulmonary vein isolation procedure for the treatment of atrial fibrillation. The investigators are conducting a randomized study to determine if 3D rotational angiography (as a mode of preprocedural imaging) performed before the cryoballoon ablation, facilitates the procedure and has positive impact on procedure characteristics and outcomes.
Detailed description
Around 50% of cardiac electrophysiology (EP) centers are using some kind of imaging to define left atrium and pulmonary vein anatomy before the pulmonary vein isolation (PVI) procedure. Most commonly, CT or MR are performed few days/weeks before the procedure. Three dimensional rotational angiography is least commonly used. However it has the advantage that it can be performed in the EP room just before the ablation procedure. There is still no consensus if any kind of imaging is really needed to perform safe and effective PVI. The investigators want to determine if 3D rotational angiography (as a mode of preprocedural imaging) has positive impact on procedure safety and efficacy. Also the investigators want to compare the immediate procedure characteristics. The investigators are conducting a randomized study with 1:1 randomization and planning to enroll around 100 participants with 1 year follow up.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Rotational angiography | Preprocedural imaging before ablation |
Timeline
- Start date
- 2019-09-01
- Primary completion
- 2023-10-01
- Completion
- 2023-10-01
- First posted
- 2020-03-03
- Last updated
- 2023-11-21
Locations
1 site across 1 country: Croatia
Source: ClinicalTrials.gov record NCT04293757. Inclusion in this directory is not an endorsement.