Registry Evaluating AF Ablation Techniques (PRIME-AF)

Prospective, Multicenter, Non-randomized Observational Registry Conducted at High Volume Experienced Treatment Centers Utilizing the Most Current AF Ablation Techniques.

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

Study Overview

• Status: Active, not recruiting
• Conditions: Atrial Fibrillation; Catheter Ablation

• Study Type: Observational
• Enrollment (Actual): 212

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium
    • Ziekenhuis Netwerk Antwerpen
• Netherlands
  • Rotterdam, Netherlands, 3015CN
    • Erasmus MC
• Russian Federation
  • Novosibirsk, Russian Federation, 630055
    • E. Meshalkin National Medical Research Center

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: Non-Probability Sample

Study Population

Patients eligible for participation in the study have a reported incidence of at least two documented episodes of symptomatic paroxysmal atrial fibrillation during the three months preceding trial entry, as well as documentation of at least one episode of AF on ECG, 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:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Manual guided RF ablation; Patients with paroxysmal atrial fibrillation treated with Manual guided RF ablation using Contact Force catheters
Cryoballoon ablation; Patients with paroxysmal atrial fibrillation treated with Cryoballoon ablation. Cryoballoon: Arctic Front Advance, Medtronic - 28 mm
RMN guided RF ablation - High power; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure time	Procedure time (minutes)	During ablation procedure
Fluoroscopy time	Fluoroscopy time (minutes)	During ablation procedure
Transseptal time	Transseptal time (time from insertion of catheters until transseptal puncture) (minutes)	During ablation procedure
Left atrial dwell time	Left atrial dwell time (time from LA entry until removal of catheters) (minutes)	During ablation procedure
PVI ablation time	PVI ablation time (total PVI ablation time, i.e. first until last application) (minutes)	During ablation procedure
Ablation time per pulmonary vein	Ablation time per pulmonary vein (minutes)	During ablation procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First Pass Isolation	First Pass Isolation (i.e. Successful isolation of PVs after the first ablation attempt)	During ablation procedure
Acute success	Acute success (Successful electrical isolation of PVs at the end of procedure)	During ablation procedure
TouchUp rates	TouchUp rates (additional applications for successful PV isolation)	During ablation procedure
Long-term success	Long-term success (freedom of atrial fibrillation 12 months after ablation)	From the date of procedure until 1 year
Procedure-related adverse-events	Procedure-related adverse-events	From the date of procedure until 7 days
Long-term adverse events	Long-term adverse events	From the date of procedure until 1 year

Collaborators and Investigators

• Sponsor: Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2018
• Primary Completion (Actual): June 9, 2021
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: September 20, 2018
• First Submitted That Met QC Criteria: October 3, 2018
• First Posted (Actual): October 4, 2018

Study Record Updates

• Last Update Posted (Actual): January 26, 2022
• Last Update Submitted That Met QC Criteria: January 25, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Catheter Ablation; Radiofrequency ablation; Paroxysmal Atrial Fibrillation; Cryoballoon; Remote Magnetic Navigation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: PRIME-AF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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