NL-OMON50243
Completed
Not Applicable
Clinical Evaluation of the StablePoint Catheter and Force-Sensing System for Paroxysmal Atrial Fibrillation - NEWTON AF
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation - Abnormal heart rhythm
- Sponsor
- Boston Scientific
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\* History of recurrent symptomatic Paroxysmal Atrial Fibrillation (PAF),
- •defined as atrial fibrillation (AF) that terminates spontaneously or with
- •intervention (either procedure or drug therapy) within seven days of onset.
- •Minimum documentation includes the following:
- •o a physician\*s note indicating recurrent self\-terminating atrial fibrillation
- •(AF) which includes at least two symptomatic AF episodes in the patient\*s
- •history within the last 6 months prior to enrollment, and
- •o any electrocardiographically documented AF episode within 12 months prior to
- •enrollment.
- •\* Subjects who are eligible for an ablation procedure for PAF according to 2017
Exclusion Criteria
- •\* Subjects with New York Heart Association (NYHA) Class III or IV heart failure
- •\< 180 days prior to enrollment
- •\* Left atrial diameter \> 5\.0 cm or left atrial volume \>50 ml/m² indexed based
- •on the most recent echocardiography
- •\* Left ventricular ejection fraction \< 35% based on the most recent
- •echocardiogram
- •\* Continuous AF lasting longer than seven (7\) days
- •\* Subjects who have undergone any previous left atrial cardiac ablation (RF,
- •Cryo, surgical)
- •\* Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or
Outcomes
Primary Outcomes
Not specified
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