Evaluation of QDOT MICRO catheter for pulmonary vein isolation (PVI) in subjects with Paroxysmal Atrial Fibrillation (PAF) (Q-fficiency)
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Atrial Fibrillation
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Age: Between 18 - 100 Years
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Gender: Male or Female
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Other Inclusion Criteria:
- Subjects with symptomatic paroxysmal atrial fibrillation (AF) with one electrocardiographically documented AF episode within 6 months prior to enrollment
- Subjects have failed at least one (1) antiarrhythmic drug (AAD) (class I or III)
- Subjects are at least 18 years old
- Subjects are able to complete and sign the written consent form
- Subjects are able and willing with all pre-, post- and follow up testing and requirements
You may not be eligible for this study if the following are true:
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- Subjects who had previous surgical or catheter ablation for atrial fibrillation.
- Subjects who had AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
- Subjects on amiodarone at any time during the past 3 months prior to enrollment
- Subjects previously diagnosed with persistent or long-standing persistent AF and/or Continuous AF lasting > 7 days
- Subjects who had CABG surgery within the past 6 months
- Subjects who had valvular cardiac surgical/percutaneous procedure
- Subjects with any carotid stenting or endarterectomy within the last 6 months
- Subjects with Documented LA thrombus on imaging, LA size > 50 mm and LVEF < 40%
- Subjects have contraindication to anticoagulation or a history of blood clotting or bleeding abnormalities
- Subjects with Documented thromboembolic event
- Subjects with Rheumatic Heart Disease or Uncontrolled heart failure or NYHA function class III or IV
- Subjects with unstable angina or active systemic infection or sepsis
- Subjects with significant pulmonary disease
- Subjects with severe Gastroesophageal Reflux Disease
- Subjects with significant congenital anomaly or medical problem
- Female subjets who are pregnant
- Subjects enrolled in an investigational study evaluating another device, biologic, or drug.
- Subjects with contra-indication for the devices
If you are registered as a volunteer, please login to the dashboard to send referrals.