Clinical trial NCT04362683: High Power Short Duration Ablation for Paroxysmal AF With High Density Multi Directional Mapping (LOWE AF HD Study).
Official title: Loop Recorder Evaluation in Patients Treated With High Power Short Duration Ablation for Paroxysmal Atrial Fibrillation With High Density Multi Directional Mapping (LOWE AF HD Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Keywords: AF
High Power - Short Duration Ablation
High Density Mapping
Lead sponsor: Ospedale S. Giovanni Bosco
Sponsor class: OTHER
First posted: 2020-04-27
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients eligible for participation in the study have indication for ablation of paroxysmal AF and are eligible for PVI by catheter ablation based on the respective ACC/AHA/ESC Guideline valid at the date of procedure.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acute Procedural Success Rate
timeFrame: 1 day
measure: Rate of patients without Atrial Fibrillation recurrences
timeFrame: 12 months after 3-months blanking period
Secondary outcomes:
measure: Adverse events rate
timeFrame: 1 month
measure: Ablation Procedure Time
timeFrame: 1 day
measure: Ablation Fluoroscopic Time
timeFrame: 1 day
measure: Number of radiofrequency applications
timeFrame: 1 day
measure: Total radiofrequency ablation time
timeFrame: 1 day
measure: First pass pulmonary vein isolation
timeFrame: 1 day
measure: Number of atrial fibrillation events
timeFrame: 12 months
measure: Atrial Fibrillation Burden
timeFrame: 12 months
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Ospedale San Giovanni Bosco
Study officials:
affiliation: Ospedale San Giovanni Bosco
name: Gregorio Covino, MD
role: PRINCIPAL_INVESTIGATOR
References: