Trials / Completed
CompletedNCT05711589
Zero-fluoroscopic Cryoballoon Ablation
Safety and Efficacy of Intracardiac Echocardiography-guided Zero-fluoroscopic Cryoballoon Ablation for Atrial Fibrillation : A Prospective Randomized Controlled Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- Pusan National University Hospital · Academic / Other
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
This study aimed to investigate safety and efficacy of intracardiac echocardiography (ICE)-guided zero-fluoroscopic cryoballoon ablation (CBA) in patients with paroxysmal atrial fibrillation.
Detailed description
Patients (n=100) undergoing de novo CBA for paroxysmal AF were randomly assigned (1:1) to zero-fluoroscopic (Zero-X) and conventional fluoroscopy groups. Radiation exposure, procedural time, acute and long term outcome were analyzed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | CBA was performed under intracardiac echocardiography guidance without fluoroscopy | Zero-X group: Patients undergoing ICE-guided CBA |
| PROCEDURE | cryoablation (CBA) was performed under fluoroscopic guidance | cryoablation (CBA) was performed under fluoroscopic guidance |
Timeline
- Start date
- 2020-01-01
- Primary completion
- 2022-06-30
- Completion
- 2022-12-31
- First posted
- 2023-02-03
- Last updated
- 2023-02-03
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT05711589. Inclusion in this directory is not an endorsement.