High Power Short Duration Ablation for Paroxysmal AF With High Density Multi Directional Mapping (LOWE AF HD Study). (LOWE-AF-HD)

Gregorio Covino

Status: Unknown

Conditions: Atrial Fibrillation

Study type: Observational

Funder types: Other

Identifiers

NCT04362683

SGB01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 83 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

83 participants in 1 patient group

High Power Atrial Fibrillation Ablation

Description:

In our center, routine medical care for atrial fibrillation ablation includes: Multidirectional high-density mapping High power - short duration settings Contact force sensing ablation catheter