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 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT07027969
Eligibility Criteria:
INCLUSION CRITERIA
Entry into the study would require that the patient:
1. Is a candidate for general anesthesia
2. Is eligible for metabolic surgery (RYGB or SG)
3. Is ≥18 and ≤80 years old
4. has a BMI ≥35 and ≤65 kg/m2
5. has AF criteria, which:
1. Must be documented by EKG or cardiac monitor or Zio XT Patch
2. Must have symptomatic AF
3. In terms of types of AF, either paroxysmal AF with at least one episode lasting ≥5 minutes in the last 3 months prior to screening, or persistent AF, or longstanding AF.
4. Must have a minimum burden of 1% during a 2-week screening time with an ambulatory noninvasive cardiac monitor.
5. Must be assessed and confirmed by an expert cardiologist (e.g., cardiac electrophysiologist) to meet eligibility.
6. Patients without history of prior AF ablation/PVI procedure or with history of prior failed AF ablation/PVI procedure are eligible for the study.
7. Patients with and without T2DM are eligible for the study. Patients with T2DM should have been on a stable dose of anti-diabetic medication (including insulin) for at least 3 months prior to entry, with HbA1c ≤12%.
8. Have the ability and willingness to participate in the study and agree to any of the arms involved in the study.
9. Able to understand the options and to comply with the requirements of each arm.
10. Have a negative urine pregnancy test at screening and randomization visits for women of childbearing potential.
11. Women, of childbearing age, must agree to use reliable method of contraception for 2 years.
EXCLUSION CRITERIA
1. Significant cardiac valvular disease (planned to undergo cardiac valve intervention/surgery in the next 12 months)
2. Significant atherosclerotic disease (planned to undergo coronary, carotid, or peripheral artery revascularization procedures in the next 12 months)
3. Severe uncompensated cardiopulmonary disease leading to American Society of Anesthesiologists Class IV or V
4. Classified as New York Heart Association Class IV
5. Left ventricular ejection fraction \<20% at the time of screening
6. Hospitalization for myocardial infarction, unstable angina, stroke, transient ischemic attack, heart surgery, coronary stent placement in the past 6 months
7. Prior bariatric and metabolic surgery of any kind (patients who had a gastric balloon or gastric band that were removed more than one year prior to enrollment are allowed to participate)
8. History of solid organ transplant
9. Type 1 diabetes or autoimmune diabetes
10. eGFR \< 30 mL/min/1.73 m2 at screening or being on dialysis
11. Decompensated cirrhosis characterized by ascites, hepatic encephalopathy, portal hypertension, or esophageal varices.
12. Anemia defined as hemoglobin less than 9 g/dL
13. Use of investigational therapy
14. Liver transaminase level \>300 U/L
15. Significant alcohol use (average \>2 drinks/day)
16. Presence of active malignancy (except non-melanoma skin cancer)
17. Life expectancy less than 3 years due to concomitant diseases
18. Major mental health, psychological disorders, or substance abuse disorders that in the opinion of the investigators could disqualify the patient from metabolic surgery
19. Any condition or major illness that, in the investigator's judgment, places the subject at undue risk by participating in the study
20. Unable to understand the risks, benefits and compliance requirements of study
21. Lack capacity to give informed consent
22. Plans to move outside the primary location of study (Northeast Ohio) within the next 12 months
23. Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures
24. Known adhesive allergies
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07027969
Study Brief:
Protocol Section:
NCT07027969