Registry Evaluating AF Ablation Techniques

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Anne-Marie Noten，Erasmus Medical Center

Tracking Information

First Submitted Date ^ICMJE

September 20, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

October 1, 2018

Estimated Primary Completion Date

October 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Procedure time[ Time Frame: During ablation procedure ]

Procedure time (minutes)

Fluoroscopy time[ Time Frame: During ablation procedure ]

Fluoroscopy time (minutes)

Transseptal time[ Time Frame: During ablation procedure ]

Transseptal time (time from insertion of catheters until transseptal puncture) (minutes)

Left atrial dwell time[ Time Frame: During ablation procedure ]

Left atrial dwell time (time from LA entry until removal of catheters) (minutes)

PVI ablation time[ Time Frame: During ablation procedure ]

PVI ablation time (total PVI ablation time, i.e. first until last application) (minutes)

Ablation time per pulmonary vein[ Time Frame: During ablation procedure ]

Ablation time per pulmonary vein (minutes)

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

Registry Evaluating AF Ablation Techniques

Official Title ^ICMJE

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

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

Study Type ^ICMJE

Observational [Patient Registry]

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational [Patient Registry]
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

Study Arms

: 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.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

600

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

October 2022

Estimated Primary Completion Date

October 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Anne-Marie Noten，Erasmus Medical Center

Study Sponsor ^ICMJE

Erasmus Medical Center

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Erasmus Medical Center

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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