Trials / Unknown
UnknownNCT03649022
"Ventricular Tachycardia Ablation Registry".
"Ventricular Tachycardia Ablation Registry". Italian Registry of Substrate Mapping and VT Ablation With the Precision Mapping System and Flexability Catheter.
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 312 (actual)
- Sponsor
- Paolo Della Bella · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Catheter ablation of Ventricular Tachycardias is a well-established approach in clinical practice in patients with Implantable Cardioverter Defibrillator (ICD) implanted. Previous studies have shown a significant reduction in appropriate shocks (\~ 20%) and a significant reduction in hospitalizations for cardiovascular reasons (\~ 12%) in patients with ischemic heart disease treated with ablation. Recent works have also shown the effectiveness of the ablation procedure using as procedural target the reduction of late potentials. However, actually it is necessary to have an homogenize and accepted mapping scheme in Sinus Rhythm to ablate Ventricular Tachycardias related to scar substrate in patients with: * Previous MI * Previous myocarditis * Arrhythmogenic Right Ventricular Dysplasia (ARVD) * Idiopathic Dilated Cardiomyopathy (IDCM) Scope of the registry is to collect data during cardiac mapping in Sinus Rhythm in patients indicated for Ventricular Tachycardia ablation, that will be performed per clinical practice, by using the St. Jude Medical EnSiteTM PrecisionTM mapping system. The objective of the present registry is: to assess the acute and long-term efficacy of the strategy of substrate abolition (abolishment of complex and late potentials) guided by electroanatomic mapping with Precision software.
Detailed description
This is an Italian multicenter, observational, prospective and retrospective registry. Data will be collected during enrollment/baseline, procedure, pre-discharge and during the follow-up visits according to the standard practice of participating centers, with mandatory visits at 6 and 12 months. Data can also be collected retrospectively, prior informed consent of the patient. The planned enrollment duration is approximately 24 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Catheter ablation | Ventricular Tachycardia ablation, that will be performed per clinical practice, by using EnSite Precision mapping system with the Flexability catheter (St.Jude, now Abbott) |
Timeline
- Start date
- 2017-07-25
- Primary completion
- 2021-01-31
- Completion
- 2021-01-31
- First posted
- 2018-08-28
- Last updated
- 2020-04-14
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT03649022. Inclusion in this directory is not an endorsement.