Registry Evaluating AF Ablation Techniques (PRIME-AF)

Erasmus University

Status: Unknown

Conditions: Atrial Fibrillation; Catheter Ablation

Study type: Observational

Funder types: Other

Identifiers

NCT03695484

PRIME-AF

Details and patient eligibility

About

The purpose of this observational registry is to prospectively collect procedure efficiency, safety and acute and long term outcome data from catheter ablation procedures as treatment of paroxysmal atrial fibrillation, using the following treatment modalities:

• Cryoballoon ablation
• Manual guided RF ablation using Contact Force catheters
• Remote Magnetic Navigation guided RF ablation with e-Contact and high power settings
• Remote Magnetic Navigation guided RF ablation with e-Contact and low power settings

Enrollment: 212 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documented Paroxysmal Atrial Fibrillation
• Eligibility for Pulmonary Vein Isolation by catheter ablation based on the respective ACC/AHA/ESC Guideline valid at the date of procedure
• Signed the informed consent to participate in the registry

Exclusion criteria

• Younger than 18 years of age
• Prior AF ablation procedure (including MAZE procedure)
• Prior ablation of Non-AF Arrhythmia within 3 months of enrollment
• Presence of cardiac thrombus
• Other AF ablations performed during procedure (e.g. lines, rotor, CFAE's etc)
• Active endocarditis or systemic infection
• Life expectancy < 1 year
• Pregnancy

Trial design

212 participants in 4 patient groups

Manual guided RF ablation

Description:

Patients with paroxysmal atrial fibrillation treated with Manual guided RF ablation using Contact Force catheters

Cryoballoon ablation

Description:

Patients with paroxysmal atrial fibrillation treated with Cryoballoon ablation. Cryoballoon: Arctic Front Advance, Medtronic - 28 mm

RMN guided RF ablation - High power

Description:

Patients with paroxysmal atrial fibrillation treated with Remote Magnetic Navigation guided RF ablation with e-Contact and high power settings. High power ablation settings: a minimum of 40 Watt, 43grC, flow 17ml/min. Higher voltages (e.g. anterior wall) are allowed with respect to the operators' preference.

RMN guided RF ablation - Low power

Description:

Patients with paroxysmal atrial fibrillation treated with Remote Magnetic Navigation guided RF ablation with e-Contact and low power settings. Low power ablation settings: a maximum of 39 Watt, 43grC, flow 17ml/min. Lower voltages are allowed with respect to the operators' preference.