High-Density Wave Mapping in Subjects with Atrial Fibrillation as a Predictor of Recurrence After a Single Ablation Procedure Using a PVI-Only Strategy

High-Density Wave Mapping in Subjects with Atrial Fibrillation as a Predictor of Recurrence After a Single Ablation Procedure Using a PVI-Only Strategy - Wave-Map AF

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48012

Enrollment

Registered

2020-01-13

Start date

2019-08-28

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

arrythmia artrial fribrillation

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Documented atrial fibrillation with planned endocardial ablation procedure 2. Age 18 years or older 3. Able and willing to provide written informed consent prior to any clinical investigation related procedure 4. Able and willing to complete all required study procedures through 12 months

Exclusion criteria

Exclusion criteria: 1. Long-standing persistent atrial fibrillation defined as continuous AF greater than 12 months in duration 2. Previous ablation or surgery in the left atria 3. Implanted left atrial appendage occluder 4. Implanted mitral or tricuspid valve replacement 5. Implanted cardiac defibrillator (ICD) 6. Participation in another clinical investigation that may confound the results of this study 7. Pregnant or nursing 8. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator*s opinion, could limit the subject*s ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results. 9. Life expectancy less than 12 months

Design outcomes

Primary

Measure	Time frame
The primary outcome is one-year success, defined as freedom from AF/AFL/AT after removal from antiarrhythmic drug therapy as assessed from the end of the 3-month blanking period to 12 months following a single ablation procedure.	—

Secondary

Measure	Time frame
See page 13 and 14 of the protocol (versie A, 20 februari 2019). Acute procedural success, defined as electrical isolation of all pulmonary veins. Success post blanking period through 12 months using different definitions, including: -Freedom from symptomatic AF/AFL/AT after removal from AAD therapy -Single procedure clinical success defined as freedom from symptomatic AF/AFL/AT without a new or increased dose of class I or III AAD -Freedom from AF/AFL/AT Data from EnSite maps using both HD Wave and Standard mapping modes in both sinus rhythm and AF including but not limited to: -Left atrial area using different boundaries (e.g. with and without LAA, etc.) -Low voltage area and proportion of left atria with low voltage using different thresholds for low voltage Rates of recurrence not due to PVI gap for subjects with repeat electrophysiology studies LA volume and diameter Adverse events including any device-, procedure-, or death-related events Other baseline characteristics including but not limited to: -Time with AF -Type of AF -Sex / BMI -General medical history / Cardiovascular history / Arrhythmia history -NYHA classification / LVEF -Presence of pacemaker Procedural characteristics, including but not limited to: -Power, temperature, and contact force -Procedure time / Mapping time / Fluoroscopy time -Cardioversions (if applicable) -Anesthesia	—

Measure

Time frame

See page 13 and 14 of the protocol (versie A, 20 februari 2019). Acute procedural success, defined as electrical isolation of all pulmonary veins. Success post blanking period through 12 months using different definitions, including: -Freedom from symptomatic AF/AFL/AT after removal from AAD therapy -Single procedure clinical success defined as freedom from symptomatic AF/AFL/AT without a new or increased dose of class I or III AAD -Freedom from AF/AFL/AT Data from EnSite maps using both HD Wave and Standard mapping modes in both sinus rhythm and AF including but not limited to: -Left atrial area using different boundaries (e.g. with and without LAA, etc.) -Low voltage area and proportion of left atria with low voltage using different thresholds for low voltage Rates of recurrence not due to PVI gap for subjects with repeat electrophysiology studies LA volume and diameter Adverse events including any device-, procedure-, or death-related events Other baseline characteristics including but not limited to: -Time with AF -Type of AF -Sex / BMI -General medical history / Cardiovascular history / Arrhythmia history -NYHA classification / LVEF -Presence of pacemaker Procedural characteristics, including but not limited to: -Power, temperature, and contact force -Procedure time / Mapping time / Fluoroscopy time -Cardioversions (if applicable) -Anesthesia

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Countries

Netherlands

Outcome results