Registry Evaluating AF Ablation Techniques

Atrial Fibrillation Clinical Trial

— PRIME-AF  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03695484
• Other study ID #: PRIME-AF
• Status: Active, not recruiting
• Start date: October 31, 2018
• Est. completion date: June 30, 2022

Study information

• Verified date: January 2022
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 212
• Est. completion date: June 30, 2022
• Est. primary completion date: June 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Catheter Ablation

Locations

Country	Name	City	State
Belgium	Ziekenhuis Netwerk Antwerpen	Antwerp
Netherlands	Erasmus MC	Rotterdam
Russian Federation	E. Meshalkin National medical research center	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Countries where clinical trial is conducted

Belgium,  Netherlands,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedure time	Procedure time (minutes)	During ablation procedure
Primary	Fluoroscopy time	Fluoroscopy time (minutes)	During ablation procedure
Primary	Transseptal time	Transseptal time (time from insertion of catheters until transseptal puncture) (minutes)	During ablation procedure
Primary	Left atrial dwell time	Left atrial dwell time (time from LA entry until removal of catheters) (minutes)	During ablation procedure
Primary	PVI ablation time	PVI ablation time (total PVI ablation time, i.e. first until last application) (minutes)	During ablation procedure
Primary	Ablation time per pulmonary vein	Ablation time per pulmonary vein (minutes)	During ablation procedure
Secondary	First Pass Isolation	First Pass Isolation (i.e. Successful isolation of PVs after the first ablation attempt)	During ablation procedure
Secondary	Acute success	Acute success (Successful electrical isolation of PVs at the end of procedure)	During ablation procedure
Secondary	TouchUp rates	TouchUp rates (additional applications for successful PV isolation)	During ablation procedure
Secondary	Long-term success	Long-term success (freedom of atrial fibrillation 12 months after ablation)	From the date of procedure until 1 year
Secondary	Procedure-related adverse-events	Procedure-related adverse-events	From the date of procedure until 7 days
Secondary	Long-term adverse events	Long-term adverse events	From the date of procedure until 1 year