Registry Evaluating AF Ablation Techniques

• Conditions: Atrial Fibrillation; Catheter Ablation

• Registration Number: NCT03695484
• Lead Sponsor: Erasmus Medical Center

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-20
• Study First Submitted QC: 2018-10-03
• Study First Posted: 2018-10-04
• Study Start: 2018-10-31
• Primary Completion: 2021-06-09
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-25
• Last Update Posted: 2022-01-26
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 212

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)
Procedure-related adverse-events	From the date of procedure until 7 days	Procedure-related adverse-events
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)
Long-term adverse events	From the date of procedure until 1 year	Long-term adverse events

Trial Locations

Locations (3)

E. Meshalkin National medical research center; 🇷🇺 Novosibirsk, Russian Federation

Ziekenhuis Netwerk Antwerpen; 🇧🇪 Antwerp, Belgium

Erasmus MC; 🇳🇱 Rotterdam, Netherlands