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

Atrial Fibrillation Clinical Trial

— LOWE-AF-HD  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04362683
• Other study ID #: SGB01
• Status: Not yet recruiting
• Start date: April 30, 2020
• Est. completion date: March 31, 2023

Study information

• Verified date: April 2020
• Source: Ospedale S. Giovanni Bosco
• Contact: Gregorio Covino, MD
• Phone: +39 0812545350
• Email: elettroSGB[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 83
• Est. completion date: March 31, 2023
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Italy	Ospedale San Giovanni Bosco	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
Gregorio Covino

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Procedural Success Rate	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.	1 day
Primary	Rate of patients without Atrial Fibrillation recurrences	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).	12 months after 3-months blanking period
Secondary	Adverse events rate	Procedural and post procedural safety assessed by reporting all adverse events in the first 30 days after ablation	1 month
Secondary	Ablation Procedure Time	Complete procedure time (minutes)	1 day
Secondary	Ablation Fluoroscopic Time	Fluoroscopic time recorded (minutes) during ablation procedure	1 day
Secondary	Number of radiofrequency applications	Number of radiofrequency applications reported for each patient during ablation procedure.	1 day
Secondary	Total radiofrequency ablation time	Total time (minutes) of radiofrequency applications in each patient during ablation procedure.	1 day
Secondary	First pass pulmonary vein isolation	Number of patients in which PV isolation is obtained at first attempt.	1 day
Secondary	Number of atrial fibrillation events	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).	12 months
Secondary	Atrial Fibrillation Burden	AF Burden (in minutes) recorded at 12 months (after 3-months blanking period) of follow-up by Implantable Loop Recorder.	12 months