Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT04050969
Eligibility Criteria:
Inclusion Criteria:
* Symptomatic persistent or paroxysmal AF refractory to at least one antiarrhythmic agent
* EF \> 40%
* BMI \> 40 or BMI \> 35 and at least one of the following co-morbidities:
* Type 2 Diabetes Mellitus (by American Diabetes Association diagnostic criteria).
* Systolic blood pressure of 130 mmHg and/or diastolic blood pressure 80 mmHg or higher despite medical treatment with maximal doses of three antihypertensive medications).
* Refractory hyperlipidemia (acceptable levels of lipids unachievable with diet and maximum doses of lipid lowering medications).
* Obesity-induced cardiomyopathy.
* Clinically significant obstructive sleep apnea.
* Obesity-related hypoventilation.
* Pseudotumor cerebri (documented idiopathic intracerebral hypertension).
* Severe arthropathy of spine and/or weight-bearing joints (when obesity prohibits appropriate surgical management of joint dysfunction treatable but for the obesity).
* Hepatic steatosis without evidence of active inflammation.
* Hypertriglyceridemia
* Polycystic Ovary Syndrome (PCOS)
* Asthma
* Coronary Artery Disease (CAD)
Exclusion Criteria:
* Prior bariatric surgery
* Prior AF catheter ablation
* BMI \> 65 kg/m2
* Contraindication to bariatric surgery or AF ablation
* Contraindication to therapeutic anticoagulation
* Sustained AF lasting more than 3 years
* Left atrial diameter of greater than or equal to 60 mm or LA volume greater than or equal to 60 ml/m2
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04050969
Study Brief:
Protocol Section:
NCT04050969