Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT07027969
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-26
First Post:
2025-06-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Metabolic Surgery for Atrial Fibrillation Elimination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015390', 'term': 'Gastric Bypass'}, {'id': 'D050110', 'term': 'Bariatric Surgery'}, {'id': 'D024043', 'term': 'Collagen Type II'}, {'id': 'D013812', 'term': 'Therapeutics'}], 'ancestors': [{'id': 'D049088', 'term': 'Bariatrics'}, {'id': 'D000073319', 'term': 'Obesity Management'}, {'id': 'D005763', 'term': 'Gastroenterostomy'}, {'id': 'D000714', 'term': 'Anastomosis, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D024022', 'term': 'Fibrillar Collagens'}, {'id': 'D003094', 'term': 'Collagen'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D016326', 'term': 'Extracellular Matrix Proteins'}, {'id': 'D012596', 'term': 'Scleroproteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Patients and investigators will not be blinded to treatment assignment. However, the clinical assessors of cardiac rhythm recorders are blinded to the study arms; Assessment of the primary endpoint will be based on the blinded downloads and interpretation of Zio XT Patch (iRhythm) data yielding the AF burden.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'METSAFE is a randomized open-label blinded-endpoint single-center controlled efficacy/safety study with 2 parallel groups of patients with obesity and AF who will either receive metabolic surgery or nonsurgical obesity care for 30 months. The study has 2 phases: the first 12 months and the subsequent 18 months.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2030-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2025-06-11', 'studyFirstSubmitQcDate': '2025-06-11', 'lastUpdatePostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Participants Achieving Weight Loss Milestones', 'timeFrame': 'First 52 weeks of the study', 'description': 'Percentage of participants achieving ≥ 5%, ≥ 10%, ≥ 15%, ≥ 20%, ≥ 25%, ≥ 30%, ≥ 35% weight loss from baseline (yes/no)'}, {'measure': 'Excess Weight Loss Percentage', 'timeFrame': 'First 52 weeks of the study', 'description': 'Percentage of excess weight loss, calculated by dividing the difference between initial BMI and final BMI by the difference between initial BMI and a target BMI of 25'}, {'measure': 'Change in waist circumference', 'timeFrame': 'First 52 weeks of the study', 'description': 'Change in waist circumferential measurement above the level of the iliac crests measured in centimeters from baseline to 52 weeks'}, {'measure': 'Change in physical activity', 'timeFrame': 'First 52 weeks of the study', 'description': 'Change in physical activity, tracked by a commercial wearable device'}, {'measure': 'Systolic blood pressure trends', 'timeFrame': 'First 52 weeks of the study', 'description': 'Mean and change in systolic blood pressure in mmHg'}, {'measure': 'Change in glucose homeostasis markers in T2DM patients', 'timeFrame': 'First 52 weeks of the study', 'description': 'Mean and change from baseline in blood glucose and HbA1c in patients with T2DM'}, {'measure': 'Percentage of patients with T2DM meeting predefined HbA1c targets', 'timeFrame': 'First 52 weeks of the study', 'description': 'Percentage of patients meeting predefined HbA1c targets:\n\n* HbA1c \\<6.5% (without diabetes medications)\n* HbA1c \\<7% (irrespective of taking diabetes medications or not)'}, {'measure': 'change in anti-diabetic medication', 'timeFrame': 'First 52 weeks of the study', 'description': 'Changes in doses or drugs being used for diabetes'}, {'measure': 'Mean and change from baseline in lipid panel', 'timeFrame': 'First 52 weeks of the study', 'description': 'Mean and change from baseline in total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), and triglycerides'}, {'measure': 'Changes in inflammatory markers (CRP)', 'timeFrame': 'First 52 weeks of the study', 'description': 'Mean and change from baseline in C-Reactive Protein (CRP) in mg/L'}, {'measure': 'change in antihypertensive therapy', 'timeFrame': 'First 52 weeks of the study', 'description': 'Percentage of patients with escalation or de-escalation of antihypertensive therapy'}, {'measure': 'change in antiarrhythmic therapy', 'timeFrame': 'First 52 weeks of the study', 'description': 'Change in antiarrhythmic medications taken by the patient'}, {'measure': 'Count of Direct Current cardioversions', 'timeFrame': 'First 52 weeks of the study', 'description': 'Number of Direct Current (DC) Cardioversions'}, {'measure': 'Count of AF ablation/pulmonary vein isolation procedures', 'timeFrame': 'Throughout the study, 130 weeks', 'description': 'Number of AF ablation/pulmonary vein isolation (PVI) procedures (for increase in burden or persistence)'}, {'measure': 'Other cardiovascular therapy changes', 'timeFrame': 'First 52 weeks of the study', 'description': 'Change in other cardiovascular medications'}, {'measure': 'Change in Quality of life metrics', 'timeFrame': 'First 52 weeks of the study', 'description': 'Change from baseline in QoL metrics using Short Form Health Survey (SF-36)'}, {'measure': 'Change in body composition (via Seca mBCA 554 Bioimpedance Analysis)', 'timeFrame': 'First 52 weeks of the study', 'description': 'Change in body composition (% fat mass and % fat-free mass) as measured by Seca mBCA 554 Bioimpedance Analysis to examine correlation of changes in body composition with AF-related outcomes.'}, {'measure': 'Change in Apnea-Hypopnea Index in polysomnoraphy', 'timeFrame': 'First 52 weeks of the study', 'description': 'Change in Apnea-Hypopnea Index (AHI) in polysomnography to assess the possible positive effects of weight loss on OSA and to examine their correlation with AF-related outcomes'}, {'measure': 'Count of major clinical outcomes', 'timeFrame': 'Throughout the study, 130 weeks', 'description': 'Number of major clinical outcomes including all-cause mortality, cardiovascular mortality, stroke, transient ischemic attack, myocardial infarction, hospitalization for unstable angina, and hospitalization for heart failure.'}, {'measure': 'Safety end points', 'timeFrame': 'Throughout the study, 130 weeks', 'description': 'Complications specifically related to obesity, AF, metabolic surgery, as well as adverse events of cardiovascular medications and interventions in the trial will be recorded and evaluated.'}], 'primaryOutcomes': [{'measure': 'Relative change in total duration of being in atrial fibrillation (AF)', 'timeFrame': 'First 52 weeks of the study', 'description': 'Relative change from baseline to 52 weeks in the percentage total duration of being in AF during a 2-week monitoring period (i.e., %burden), assessed by the Zio XT Patch (iRhythm).'}], 'secondaryOutcomes': [{'measure': 'Presence of at least 1 AF episode', 'timeFrame': 'First 52 weeks of the study', 'description': 'Presence of at least 1 AF episode (present or absent) in a 2-week monitoring time by Zio XT Patch at 52 weeks.'}, {'measure': 'Change in number of AF episodes (≥30 seconds)', 'timeFrame': 'First 52 weeks of the study', 'description': 'Change in Zio XT Patch derived variables from baseline to 52 weeks including number of AF episodes (≥30 seconds) in a 2-week monitoring time.'}, {'measure': 'Change in number of AF espisodes longer than 6 minutes', 'timeFrame': 'First 52 weeks of the study', 'description': 'Change in Zio XT Patch derived variables from baseline to 52 weeks including number of AF episodes longer than 6 minutes in a 2-week monitoring time.'}, {'measure': 'Change in the longest AF duration', 'timeFrame': 'First 52 weeks of the study', 'description': 'Change in Zio XT Patch derived variables from baseline to 52 weeks including the longest AF duration in a 2-week monitoring time.'}, {'measure': 'Change in the second longest AF duration', 'timeFrame': 'First 52 weeks of the study', 'description': 'Change in Zio XT Patch derived variables from baseline to 52 weeks including the second longest AF duration in a 2-week monitoring time.'}, {'measure': 'Change in the AF type', 'timeFrame': 'First 52 weeks of the study', 'description': 'Change in the AF type (e.g. regression from or progression to persistent form of AF)'}, {'measure': 'Change in AF Symptom burden', 'timeFrame': 'First 52 weeks of the study', 'description': 'Change in AF Symptom burden and severity assessed by the Toronto AF Severity Score (AFSS)'}, {'measure': 'Relapse of AF after ablation', 'timeFrame': 'Throughout the study, 130 weeks', 'description': 'Number of relapses of AF after ablation in each group\n\n\\*Since more ablation is expected in the second phase of study, this end point will be more relevant in the phase 2 of study.'}, {'measure': 'Change in cardiac structure', 'timeFrame': 'First 52 weeks of the study', 'description': 'Change in cardiac structure assessed by transthoracic echocardiography including LA and LV size, morphology, and function'}, {'measure': 'Change in weight', 'timeFrame': 'First 52 weeks of the study', 'description': 'Percent and absolute changes in body weight and BMI'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atrial Fibrillation', 'Bariatric Surgery', 'Metabolic Syndrome', 'Weight Loss Surgery', 'Roux-en-Y gastric bypass', 'Sleeve Gastrectomy', 'GLP-1 Receptor Agonist', 'Tirzepatide', 'Semaglutide'], 'conditions': ['Atrial Fibrillation', 'Obesity and Obesity-related Medical Conditions']}, 'descriptionModule': {'briefSummary': "Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia. It is estimated that between 3 and 6 million Americans are currently living with AF, while 12 million people in the United States will have AF in 2030. Obesity and its comorbidities such as type 2 diabetes (T2DM), hypertension, and obstructive sleep apnea (OSA) are major risk factors for development and progression of AF. Metabolic and Bariatric Surgery (MBS) is the most effective currently available treatment for obesity. Patients typically lose 20 to 35 percent of body weight after surgery which is often sustained for many years. MBS can improve all 5 major risk factors of AF including obesity, hypertension, T2DM, OSA, and systemic inflammation.\n\nThe purpose of the study is to understand if MBS can affect the severity of AF and the toll AF's symptoms take on patients.", 'detailedDescription': "This is randomized trial of 100 patients with BMI ≥35 kg/m2 and AF. Patients who met the initial screening criteria (including presence of at least 1% AF burden during a 2-week monitoring period with an ambulatory cardiac monitor) will be invited for possible enrollment. Patients will then be randomized 1:1 to MBS group versus nonsurgical control group and will be followed for 12 months (phase 1) and then for an additional 18 months (phase 2).\n\nInterventions include Roux-en-Y Gastric Bypass or Sleeve Gastrectomy surgical procedures based on the shared medical decision between the bariatric surgeon and patients considering the patient's conditions. In the control group, patients are allowed to take anti-obesity medications (AOMs) that are not contraindicated in patients with AF at the discretion of obesity medicine specialists.\n\nLifestyle and risk factor modification in both groups will consist of targeted and personalized diet plans, exercise, and risk factor reduction, including optimal therapies for T2DM, hypertension, dyslipidemia, heart failure, coronary artery disease, and OSA."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "INCLUSION CRITERIA\n\nEntry into the study would require that the patient:\n\n1. Is a candidate for general anesthesia\n2. Is eligible for metabolic surgery (RYGB or SG)\n3. Is ≥18 and ≤80 years old\n4. has a BMI ≥35 and ≤65 kg/m2\n5. has AF criteria, which:\n\n 1. Must be documented by EKG or cardiac monitor or Zio XT Patch\n 2. Must have symptomatic AF\n 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.\n 4. Must have a minimum burden of 1% during a 2-week screening time with an ambulatory noninvasive cardiac monitor.\n 5. Must be assessed and confirmed by an expert cardiologist (e.g., cardiac electrophysiologist) to meet eligibility.\n6. Patients without history of prior AF ablation/PVI procedure or with history of prior failed AF ablation/PVI procedure are eligible for the study.\n7. 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%.\n8. Have the ability and willingness to participate in the study and agree to any of the arms involved in the study.\n9. Able to understand the options and to comply with the requirements of each arm.\n10. Have a negative urine pregnancy test at screening and randomization visits for women of childbearing potential.\n11. Women, of childbearing age, must agree to use reliable method of contraception for 2 years.\n\nEXCLUSION CRITERIA\n\n1. Significant cardiac valvular disease (planned to undergo cardiac valve intervention/surgery in the next 12 months)\n2. Significant atherosclerotic disease (planned to undergo coronary, carotid, or peripheral artery revascularization procedures in the next 12 months)\n3. Severe uncompensated cardiopulmonary disease leading to American Society of Anesthesiologists Class IV or V\n4. Classified as New York Heart Association Class IV\n5. Left ventricular ejection fraction \\<20% at the time of screening\n6. Hospitalization for myocardial infarction, unstable angina, stroke, transient ischemic attack, heart surgery, coronary stent placement in the past 6 months\n7. 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)\n8. History of solid organ transplant\n9. Type 1 diabetes or autoimmune diabetes\n10. eGFR \\< 30 mL/min/1.73 m2 at screening or being on dialysis\n11. Decompensated cirrhosis characterized by ascites, hepatic encephalopathy, portal hypertension, or esophageal varices.\n12. Anemia defined as hemoglobin less than 9 g/dL\n13. Use of investigational therapy\n14. Liver transaminase level \\>300 U/L\n15. Significant alcohol use (average \\>2 drinks/day)\n16. Presence of active malignancy (except non-melanoma skin cancer)\n17. Life expectancy less than 3 years due to concomitant diseases\n18. Major mental health, psychological disorders, or substance abuse disorders that in the opinion of the investigators could disqualify the patient from metabolic surgery\n19. Any condition or major illness that, in the investigator's judgment, places the subject at undue risk by participating in the study\n20. Unable to understand the risks, benefits and compliance requirements of study\n21. Lack capacity to give informed consent\n22. Plans to move outside the primary location of study (Northeast Ohio) within the next 12 months\n23. Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures\n24. Known adhesive allergies"}, 'identificationModule': {'nctId': 'NCT07027969', 'acronym': 'METSAFE', 'briefTitle': 'Metabolic Surgery for Atrial Fibrillation Elimination', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Efficacy of Cardiometabolic Risk Factor Control Through Metabolic Surgery on Management and Severity of Atrial Fibrillation: METSAFE Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '23-1039'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Metabolic Surgery', 'description': 'Roux-en-Y Gastric Bypass (RYGB) and Sleeve Gastrectomy (SG)', 'interventionNames': ['Procedure: Roux-en-Y Gastric Bypass or Sleeve Gastrectomy']}, {'type': 'OTHER', 'label': 'Control group (nonsurgical standard of care for obesity)', 'description': 'In the Control group, the subjects will be receiving standard of care for nonsurgical management of obesity, including possible AOMs that are not contraindicated in patients with AF at the discretion of obesity medicine specialists.', 'interventionNames': ['Drug: Anti-Obesity Medication (AOM) treatment']}], 'interventions': [{'name': 'Roux-en-Y Gastric Bypass or Sleeve Gastrectomy', 'type': 'PROCEDURE', 'otherNames': ['Roux-en-Y Gastric Bypass (RYGB)', 'Sleeve Gastrectomy (SG)', 'Bariatric Surgery'], 'description': "Patients receive either RYGB or SG. The surgical risk, differential impact of each procedure on body weight and other obesity-related diseases, presence of other medical and mental problems, patient's behavioral factors (e.g., postoperative compliance, active smoking), medications, and goals will be considered when the patient and local medical team make a shared decision about the most appropriate surgical procedure.", 'armGroupLabels': ['Metabolic Surgery']}, {'name': 'Anti-Obesity Medication (AOM) treatment', 'type': 'DRUG', 'description': 'Implementation of obesity pharmacotherapy in the nonsurgical group includes initial assessment of side effects and response, followed by achieving a clinically meaningful weight loss (5% weight loss) after three months. Once this goal is reached, AOMs will be continued throughout the study. If a weight plateau is reached within the first AOM, then another AOM may be added in combination in a stepwise fashion. The choice of AOMs considered may include metformin, topiramate, liraglutide, dulaglutide, semaglutide, tirzepatide, and empagliflozin.', 'armGroupLabels': ['Control group (nonsurgical standard of care for obesity)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'contacts': [{'name': 'Chytaine Hall', 'role': 'CONTACT', 'email': 'hallc1@ccf.org', 'phone': '(216) 445-3983'}], 'facility': 'The Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'centralContacts': [{'name': 'Chytaine Hall', 'role': 'CONTACT', 'email': 'hallc1@ccf.org', 'phone': '216-445-3983'}, {'name': 'Ali Aminian', 'role': 'CONTACT', 'email': 'aminiaa@ccf.org', 'phone': '2164450045'}], 'overallOfficials': [{'name': 'Ali Aminani', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bariatric Research Medical Director'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ali Aminian', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ethicon, Inc.', 'class': 'INDUSTRY'}, {'name': 'iRhythm Technologies, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of Bariatric & Metabolic Institute', 'investigatorFullName': 'Ali Aminian', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}