Trials / Unknown
UnknownNCT03458273
Real Zero Fluoroscopy Catheter Ablation.
Multi-center, Observational, Retrospective Comparison of the Feasibility, Safety, and Efficacy of Real Zero Fluoroscopy Versus Conventional Fluoroscopic Catheter Ablation With and Without 3D System Support: Propensity Matched Study
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (estimated)
- Sponsor
- Medical University of Lublin · Academic / Other
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- —
Summary
A Retrospective Propensity Matched Study comparing: * real zero fluoroscopy catheter ablation * conventional fluoroscopy catheter ablation without 3D system * conventional fluoroscopy catheter ablation with 3D system
Detailed description
Catheter ablation is a well-established treatment to treat patients with a wide scope of heart arrhythmias. The study is an investigator-initiated, retrospective analysis of prospectively collected data. The study population consists of patients with right-sided arrhythmias who underwent zero-fluoroscopy catheter ablation between the years 2016 and 2018 in 3 centers and a propensity score matched patients group of patients who: * underwent conventional fluoroscopy guided catheter ablation without 3D system (Ensite/Carto) support * underwent conventional fluoroscopy guided catheter ablation with 3D system (Ensite/Carto) support Covariates for matching will be: * arrhythmia type * age of a patient * number of diagnostic catheters used during a procedure * type of a diagnostic catheter used during a procedure\]
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Zero fluoroscopy ablation | Catheter ablation for the treatment of atrial and ventricular arrhythmia - no fluoroscopy guidance |
| PROCEDURE | Conventional ablation without 3D | Catheter ablation for the treatment of atrial and ventricular arrhythmia - fluoroscopy guidance only. 3D system (Every Ensite/Carto) is not allowed |
| PROCEDURE | Conventional ablation with 3D | Catheter ablation for the treatment of atrial and ventricular arrhythmia - fluoroscopy guidance + 3D system support (Ensite/Carto) |
Timeline
- Start date
- 2018-03-10
- Primary completion
- 2018-11-01
- Completion
- 2018-12-01
- First posted
- 2018-03-08
- Last updated
- 2018-09-10
Locations
3 sites across 1 country: Poland
Source: ClinicalTrials.gov record NCT03458273. Inclusion in this directory is not an endorsement.