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METSAFE

Not yet recruitingPhase 4

Metabolic Surgery for Atrial Fibrillation Elimination

Efficacy of Cardiometabolic Risk Factor Control Through Metabolic Surgery on Management and Severity of Atrial Fibrillation: METSAFE Randomized Clinical Trial

Lead sponsor

Ali Aminian

Assets

Dulaglutide / GLP-1 / incretin class catch-all / Liraglutide / Semaglutide / Tirzepatide

Listed sites

1

Recruiting sites

Enrollment

100

estimated

Study population

Atrial fibrillation, Bariatric Surgery Candidate, Obesity / overweight

Key I/E criteria

BMI 35-65HbA1c ≤12%

Primary endpoint

Total duration of being in atrial fibrillation (AF)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07027969
Org study ID23-1039

Timeline

Milestones

Study first posted2025-06-19actual
Last update posted2026-04-17actual
Study start2026-11-01estimated
Primary completion2029-12-31estimated
Study completion2030-03-31estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Atrial fibrillationBariatric Surgery CandidateObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age80 Years
SexAll
Healthy volunteersAccepted

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

Endpoints (31)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiovascular outcomes
11
Weight & body composition
5
Cardiometabolic biomarkers
4
Glycemic / diabetes
3
Other clinical outcomes
3
Patient-reported / QoL
2
Other (unclassified)
2
Safety / tolerability / PK
1

Cardiovascular outcomes

11 endpoints
Primary/protocol endpoint/low confidence

Relative change in total duration of being in atrial fibrillation (AF)

Time frame:First 52 weeks of the study

percent change from baseline, improvement

Secondary/protocol endpoint

Presence of at least 1 AF episode

Time frame:First 52 weeks of the study

Atrial-fibrillation composite

categorical status, event

Secondary/protocol endpoint

Change in number of AF episodes (≥30 seconds)

Time frame:First 52 weeks of the study

Atrial-fibrillation composite

change from baseline, event

Secondary/protocol endpoint

Change in number of AF espisodes longer than 6 minutes

Time frame:First 52 weeks of the study

Atrial-fibrillation composite

change from baseline, event

Secondary/protocol endpoint/low confidence

Change in the longest AF duration

Time frame:First 52 weeks of the study

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in the second longest AF duration

Time frame:First 52 weeks of the study

change from baseline, improvement

Secondary/protocol endpoint

Relapse of AF after ablation

Time frame:Throughout the study, 130 weeks

Atrial-fibrillation composite

event count, event

Other/protocol endpoint/low confidence

change in antiarrhythmic therapy

Time frame:First 52 weeks of the study

descriptive

Other/protocol endpoint

Count of Direct Current cardioversions

Time frame:First 52 weeks of the study

Atrial-fibrillation composite

event count, event

Other/protocol endpoint/low confidence

Count of AF ablation/pulmonary vein isolation procedures

Time frame:Throughout the study, 130 weeks

event count, event

Other/protocol endpoint

Count of major clinical outcomes

Time frame:Throughout the study, 130 weeks

CV events (total recurrent)

event count, event

componentsAll-cause death, Cardiovascular death, Stroke (any), Expanded / custom MACE composite, Myocardial infarction (any), Unstable angina hospitalization, Heart-failure hospitalization

Weight & body composition

5 endpoints
Secondary/protocol endpoint

Change in weight

Time frame:First 52 weeks of the study

Body weight, absolute change (kg)

change from baseline, improvement

Other/protocol endpoint

Percentage of Participants Achieving Weight Loss Milestones

Time frame:First 52 weeks of the study

≥25% weight-loss responders

threshold achievement, improvement

Other/protocol endpoint

Excess Weight Loss Percentage

Time frame:First 52 weeks of the study

percent change from baseline, improvement

Other/protocol endpoint

Change in waist circumference

Time frame:First 52 weeks of the study

Waist circumference, change

change from baseline, improvement

Other/protocol endpoint

Change in body composition (via Seca mBCA 554 Bioimpedance Analysis)

Time frame:First 52 weeks of the study

Total fat mass

change from baseline, improvement

Glycemic / diabetes

3 endpoints
Other/protocol endpoint

Change in glucose homeostasis markers in T2DM patients

Time frame:First 52 weeks of the study

change from baseline, improvement

Other/protocol endpoint

Percentage of patients with T2DM meeting predefined HbA1c targets

Time frame:First 52 weeks of the study

threshold achievement, improvement

LOINC 4548-4

Other/protocol endpoint

change in anti-diabetic medication

Time frame:First 52 weeks of the study

descriptive

Cardiometabolic biomarkers

4 endpoints
Other/protocol endpoint

Systolic blood pressure trends

Time frame:First 52 weeks of the study

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Other/protocol endpoint

Mean and change from baseline in lipid panel

Time frame:First 52 weeks of the study

change from baseline, improvement

Other/protocol endpoint

Changes in inflammatory markers (CRP)

Time frame:First 52 weeks of the study

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Other/protocol endpoint

change in antihypertensive therapy

Time frame:First 52 weeks of the study

categorical status, improvement

Patient-reported / QoL

2 endpoints
Secondary/protocol endpoint

Change in AF Symptom burden

Time frame:First 52 weeks of the study

change from baseline, improvement

Other/protocol endpoint

Change in Quality of life metrics

Time frame:First 52 weeks of the study

SF-36 total

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Other/protocol endpoint/low confidence

Safety end points

Time frame:Throughout the study, 130 weeks

descriptive

Other clinical outcomes

3 endpoints
Secondary/protocol endpoint

Change in the AF type

Time frame:First 52 weeks of the study

categorical status, improvement

Other/protocol endpoint

Change in physical activity

Time frame:First 52 weeks of the study

change from baseline, improvement

Other/protocol endpoint

Change in Apnea-Hypopnea Index in polysomnoraphy

Time frame:First 52 weeks of the study

AHI, change

change from baseline, improvement

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Change in cardiac structure

Time frame:First 52 weeks of the study

change from baseline, improvement

Other/protocol endpoint/low confidence

Other cardiovascular therapy changes

Time frame:First 52 weeks of the study

change from baseline, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.