PRIME-AF: Registry Evaluating AF Ablation Techniques

Sponsor

Erasmus Medical Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03695484

Collaborator

(none)

212

Enrollment

Locations

Anticipated Duration (Months)

70.7

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Catheter Ablation

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

212 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 31, 2018

Actual Primary Completion Date :

Jun 9, 2021

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Ziekenhuis Netwerk Antwerpen	Antwerp	Belgium
2	Erasmus MC	Rotterdam	Netherlands	3015CN
3	E. Meshalkin National medical research center	Novosibirsk	Russian Federation	630055