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

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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: 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.

• Study Type: Observational
• Enrollment (Anticipated): 83

Contacts and Locations

• Study Contact: Name: Gregorio Covino, MD; Phone Number: +39 0812545350; Email: elettroSGB@gmail.com

Study Locations

• Italy
  • Napoli, Italy, 80100
    • Ospedale San Giovanni Bosco
    • Contact: Gregorio Covino, MD; Phone Number: +39 0812545350; Email: elettroSGB@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
High Power Atrial Fibrillation Ablation; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events rate	Procedural and post procedural safety assessed by reporting all adverse events in the first 30 days after ablation	1 month
Ablation Procedure Time	Complete procedure time (minutes)	1 day
Ablation Fluoroscopic Time	Fluoroscopic time recorded (minutes) during ablation procedure	1 day
Number of radiofrequency applications	Number of radiofrequency applications reported for each patient during ablation procedure.	1 day
Total radiofrequency ablation time	Total time (minutes) of radiofrequency applications in each patient during ablation procedure.	1 day
First pass pulmonary vein isolation	Number of patients in which PV isolation is obtained at first attempt.	1 day
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
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

Collaborators and Investigators

• Sponsor: Gregorio Covino
• Investigators: Principal Investigator: Gregorio Covino, MD, Ospedale San Giovanni Bosco

Study record dates

Study Major Dates

• Study Start (Anticipated): April 30, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): March 31, 2023

Study Registration Dates

• First Submitted: April 7, 2020
• First Submitted That Met QC Criteria: April 22, 2020
• First Posted (Actual): April 27, 2020

Study Record Updates

• Last Update Posted (Actual): April 27, 2020
• Last Update Submitted That Met QC Criteria: April 22, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: AF; High Power - Short Duration Ablation; High Density Mapping
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: SGB01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No