Clinical trial NCT03695484: Registry Evaluating AF Ablation Techniques
Official title: Prospective, Multicenter, Non-randomized Observational Registry Conducted at High Volume Experienced Treatment Centers Utilizing the Most Current AF Ablation Techniques.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Catheter Ablation
Keywords: Paroxysmal Atrial Fibrillation
Catheter Ablation
Cryoballoon
Radiofrequency ablation
Remote Magnetic Navigation
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2018-10-04
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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


Eligibility criteria: 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

Primary outcomes:
measure: Procedure time
timeFrame: During ablation procedure
measure: Fluoroscopy time
timeFrame: During ablation procedure
measure: Transseptal time
timeFrame: During ablation procedure
measure: Left atrial dwell time
timeFrame: During ablation procedure
measure: PVI ablation time
timeFrame: During ablation procedure
measure: Ablation time per pulmonary vein
timeFrame: During ablation procedure
Secondary outcomes:
measure: First Pass Isolation
timeFrame: During ablation procedure
measure: Acute success
timeFrame: During ablation procedure
measure: TouchUp rates
timeFrame: During ablation procedure
measure: Long-term success
timeFrame: From the date of procedure until 1 year
measure: Procedure-related adverse-events
timeFrame: From the date of procedure until 7 days
measure: Long-term adverse events
timeFrame: From the date of procedure until 1 year
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Ziekenhuis Netwerk Antwerpen
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Novosibirsk
country: Russian Federation
facility: E. Meshalkin National medical research center
Study officials:
References: