Registry Evaluating AF Ablation Techniques

NCT03695484 | Unknown

• 1 other identifier: PRIME-AF
• Study Type: observational
• Target: 212
• Locations: 3 countries
• Sites: 3

Brief Summary

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

Conditions

Atrial Fibrillation; Catheter Ablation

Keywords

Paroxysmal Atrial Fibrillation; Catheter Ablation; Cryoballoon; Radiofrequency ablation; Remote Magnetic Navigation

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (6)

• First Pass Isolation

  During ablation procedure

• Acute success

  During ablation procedure

• TouchUp rates

  During ablation procedure

• Long-term success

  From the date of procedure until 1 year

• Procedure-related adverse-events

  From the date of procedure until 7 days

Study Arms (4)

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.

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (3)

Ziekenhuis Netwerk Antwerpen

Antwerp, Belgium

Location

Erasmus MC

Rotterdam, 3015CN, Netherlands

Location

E. Meshalkin National medical research center

Novosibirsk, 630055, Russia

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: October 4, 2018
• Study Start: October 31, 2018
• Primary Completion: June 9, 2021
• Study Completion: June 30, 2022
• Last Updated: January 26, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1); BE (1); NL (1)