Status:
UNKNOWN
High Power Short Duration Ablation for Paroxysmal AF With High Density Multi Directional Mapping (LOWE AF HD Study).
Lead Sponsor:
Gregorio Covino
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
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 fibr...
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 u...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 30 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2023
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT04362683
Start Date
April 30 2020
End Date
March 31 2023
Last Update
April 27 2020
Active Locations (1)
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1
Ospedale San Giovanni Bosco
Napoli, Italy, 80100