Atrial Fibrillation
Conditions
Keywords
AF, High Power - Short Duration Ablation, High Density Mapping
Brief summary
The LOWE AF HD is a prospective, single-center, non-randomized study to assess safety, efficacy, acute and long-term outcome data of a specific ablation approach as treatment of paroxysmal atrial fibrillation.
Detailed description
Pulmonary vein isolation using radiofrequency (RF) ablation is acknowledged used treatment strategy for atrial fibrillation, many different approaches are recently implemented. The specific approach used in this study includes: * Multi-directional high-density mapping * High power - short duration settings * Contact force sensing ablation catheter The aim of LOWE AF HD is to assess the acute safety and success rate of this approach and also the long-term outcome assessed by atrial recurrences arrythmias collected by an implantable loop recorder.
Interventions
None listed
Sponsors
Gregorio Covino
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Consecutive and unselected patients with a class I-IIa indication for ablation of paroxysmal AF * 18 Years and older. * Able and willing to provide written informed consent prior to any clinical investigation related procedure * Able and willing to complete all required study procedures through 12 months * Life expectancy less than 12 months
Exclusion criteria
* Persistent or long-standing persistent AF * Presence of thrombus in left atrium and left atrium appendage * MI, CABG or PCI within preceding 3 months * Left atrial diameter \> 5.0 cm * LVEF \< 35% * NYHA class III or IV * Previous atrial fibrillation ablation procedure with high density and high-power short duration approach * Previous tricuspid or mitral valve repair surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Procedural Success Rate | 1 day | Acute procedural success defined as electrical isolation of all pulmonary veins, confirmed by the high-density voltage remap and loss of pace capture along ablation line after complete isolation. |
| Rate of patients without Atrial Fibrillation recurrences | 12 months after 3-months blanking period | Freedom from Atrial Fibrillation (AF) defined as any documented recurrence of AF and/or atrial tachycardia (AT) and /or atrial flutter (AFL), lasting longer than 30 second, assessed from the end of the 3-months blanking period to 12 months following a single ablation procedure and collected by Implantable Loop Recorder (ILR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ablation Fluoroscopic Time | 1 day | Fluoroscopic time recorded (minutes) during ablation procedure |
| Number of radiofrequency applications | 1 day | Number of radiofrequency applications reported for each patient during ablation procedure. |
| Total radiofrequency ablation time | 1 day | Total time (minutes) of radiofrequency applications in each patient during ablation procedure. |
| Adverse events rate | 1 month | Procedural and post procedural safety assessed by reporting all adverse events in the first 30 days after ablation |
| Number of atrial fibrillation events | 12 months | Number of AF events symptomatic and asymptomatic assessed from the end of the 3-months blanking period to 12 months following a single ablation procedure and collected by Implantable Loop Recorder (ILR). |
| Atrial Fibrillation Burden | 12 months | AF Burden (in minutes) recorded at 12 months (after 3-months blanking period) of follow-up by Implantable Loop Recorder. |
| First pass pulmonary vein isolation | 1 day | Number of patients in which PV isolation is obtained at first attempt. |
| Ablation Procedure Time | 1 day | Complete procedure time (minutes) |
Countries
Italy
Contacts
Primary ContactGregorio Covino, MD
Outcome results
None listed