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

NCT04362683 | Unknown

• 1 other identifier: SGB01
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

AF; High Power - Short Duration Ablation; High Density Mapping

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Adverse events rate

  1 month

• Ablation Procedure Time

  1 day

• Ablation Fluoroscopic Time

  1 day

• Number of radiofrequency applications

  1 day

• Total radiofrequency ablation time

  1 day

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Consecutive and unselected patients with a class I-IIa indication for ablation of paroxysmal AF
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gregorio Covino: lead

Study Sites (1)

Ospedale San Giovanni Bosco

Napoli, 80100, Italy

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gregorio Covino, MD

  Ospedale San Giovanni Bosco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregorio Covino, MD

CONTACT

+39 0812545350; elettroSGB@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 27, 2020
• Study Start: April 30, 2020
• Primary Completion: December 31, 2021
• Study Completion: March 31, 2023
• Last Updated: April 27, 2020

Record last verified: 2020-04

Locations

IT (1)