Metabolic Surgery for Atrial Fibrillation

(METSAFE Trial)

Overseen By Ali Aminian

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Ali Aminian

Must not be taking: Investigational therapy

Disqualifiers: Cardiac disease, Organ transplant, Type 1 diabetes, Alcohol use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether metabolic and bariatric surgeries, such as Roux-en-Y Gastric Bypass and Sleeve Gastrectomy, can reduce the severity of atrial fibrillation (AF), a common heart rhythm issue. The research targets individuals who are significantly overweight and have symptomatic AF. Suitable candidates have a BMI between 35 and 65 and have recently experienced at least one noticeable AF episode. Participants will either undergo surgery or receive standard non-surgical obesity treatments to determine which approach better manages AF symptoms. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, allowing researchers to understand its benefits for more patients.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have type 2 diabetes, you should have been on a stable dose of your anti-diabetic medication for at least 3 months before joining the study.

What is the safety track record for Roux-en-Y Gastric Bypass and Sleeve Gastrectomy?

A previous study found that both Roux-en-Y gastric bypass and sleeve gastrectomy surgeries helped reverse atrial fibrillation (AF), a heart rhythm problem, in patients. Specifically, 71% of patients who underwent Roux-en-Y gastric bypass and 56% of those who had sleeve gastrectomy experienced a reversal of their AF. This suggests that both surgeries can positively affect heart rhythm issues.

Regarding safety, research shows that Roux-en-Y gastric bypass may better control diabetes and reduce the risk of major heart problems, such as heart attacks. Sleeve gastrectomy has also been shown to lower the chance of developing new AF by 29% compared to those who didn't have surgery.

Overall, these studies suggest that both surgeries are generally safe for patients with obesity and AF and are linked to better heart health. However, like any surgery, risks are involved, so discussing these with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about metabolic surgery for atrial fibrillation (AF) because it tackles the root cause—obesity—rather than just managing symptoms. Unlike standard treatments for AF, which often include medications like beta-blockers or anticoagulants, metabolic surgeries such as Roux-en-Y Gastric Bypass and Sleeve Gastrectomy aim to reduce weight dramatically, which can lead to improvements in AF symptoms. This approach might offer a dual benefit: helping control AF while also addressing obesity-related health issues. By focusing on this underlying issue, these surgeries could potentially provide longer-lasting relief and improve overall health outcomes for patients with AF and obesity.

What evidence suggests that metabolic surgery might be an effective treatment for atrial fibrillation?

This trial will compare the effects of metabolic surgeries, specifically Roux-en-Y Gastric Bypass (RYGB) and Sleeve Gastrectomy, with nonsurgical standard care for obesity. Studies have shown that weight-loss surgeries like RYGB and Sleeve Gastrectomy can lower the risk of atrial fibrillation (AF), a common heart rhythm issue. Specifically, individuals who underwent bariatric surgery had a 29% lower chance of developing AF compared to those who did not. Research also indicates that these surgeries can reduce the risk of heart failure by up to 73%. Additionally, RYGB is linked to a lower risk of major heart problems, such as heart attacks, compared to other surgeries. These procedures help patients lose significant weight, improving several risk factors related to AF. ^{2 4 6 7 8}

Who Is on the Research Team?

Ali Aminani

Principal Investigator

Bariatric Research Medical Director

Are You a Good Fit for This Trial?

This trial is for individuals with obesity and atrial fibrillation, a common heart rhythm disorder. Participants should have related health issues like type 2 diabetes, high blood pressure, or sleep apnea. The study excludes those who don't meet specific health criteria that will be detailed by the researchers.

Inclusion Criteria

I am fit for general anesthesia.

I am a candidate for weight loss surgery.

AF criteria documented by EKG, cardiac monitor, or Zio XT Patch with symptomatic AF

Exclusion Criteria

I have an active cancer other than non-melanoma skin cancer.

I am scheduled for a procedure to improve blood flow in my arteries within a year.

NYHA Class IV

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment Phase 1

Participants undergo metabolic surgery or receive standard care for obesity management, followed by lifestyle and risk factor modification

52 weeks

Regular visits as per treatment protocol

Follow-up Phase 1

Participants are monitored for changes in cardiac structure, weight, and other health metrics

52 weeks

Regular monitoring visits

Treatment Phase 2

Continuation of treatment and monitoring, with potential for more ablation procedures

78 weeks

Regular visits as per treatment protocol

Follow-up Phase 2

Extended monitoring for relapse of AF and other long-term outcomes

78 weeks

Regular monitoring visits

What Are the Treatments Tested in This Trial?

Interventions

• Roux-en-Y Gastric Bypass
• Sleeve Gastrectomy

Trial Overview The study tests if weight loss surgeries (Roux-en-Y Gastric Bypass or Sleeve Gastrectomy) can improve atrial fibrillation symptoms compared to anti-obesity medication treatment alone.

How Is the Trial Designed?

Group I: Control group (nonsurgical standard of care for obesity) Experimental Treatment 1 Intervention

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.

Group II: Metabolic Surgery Active Control 1 Intervention

Roux-en-Y Gastric Bypass (RYGB) and Sleeve Gastrectomy (SG)

Who Is Running the Clinical Trial?

Ali Aminian

Lead Sponsor

Trials

4

Recruited

4,500+

Ethicon, Inc.

Industry Sponsor

Trials

95

Recruited

62,300+

Tim Schmid

Ethicon, Inc.

Chief Executive Officer since 2023

Undergraduate degree from the University of Western Ontario, MBA from Richmond University in the United Kingdom

Nancy Sabin

Ethicon, Inc.

Chief Medical Officer

MBA from the University of Pennsylvania’s Wharton School of Business, B.S. in Engineering from Duke University

iRhythm Technologies, Inc.

Industry Sponsor

Trials

4

Recruited

1,400+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8076511/

The Long-Term Impact of Bariatric Surgery on Development of ... A prospective randomized study showed that the use of Roux-en-Y gastric bypass (RYGB) in morbidly obese patients was associated with higher rates of diabetes ...

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCEP.119.007598?doi=10.1161/CIRCEP.119.007598

Outcomes of Atrial Fibrillation Ablation in Morbidly Obese ... Within 12 months of ablation, recurrent arrhythmia occurred in 5 (10%) patients in the BS group compared with 15 (15%) patients in the nonobese ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666501820300362

Clinical Atrial Fibrillation Bariatric surgery to aLleviate ... Conclusion. In patients undergoing BAS, the risk of either HF or AF was reduced by ∼29% but with greater risk of GIB. The findings support ...

4. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2833512

Major Adverse Cardiac Events After Gastric Bypass vs ... Gastric bypass was associated with a lower risk of MACE compared with sleeve gastrectomy, primarily due to reduced rates of myocardial infarction.

5. mdpi.com mdpi.com/2077-0383/12/15/4973

Outcomes at 10-Year Follow-Up after Roux-en-Y Gastric ... RYGB and Long-Limb BPD were able to produce a TWL of 37.6% (SD 10.6%) and 37.5% (SD 11.1) on average after 10 years of follow-up. Laparoscopic ...

6. ahajournals.org ahajournals.org/doi/10.1161/CIRCEP.119.007626

Impact of Bariatric Surgery on Atrial Fibrillation Type Reversal occurred in 71% of patients following Roux-en-Y gastric bypass compared with 56% of patients who underwent sleeve gastrectomy and 50% ...

7. diabetesjournals.org diabetesjournals.org/care/article/44/11/2552/138507/Cardiovascular-Outcomes-in-Patients-With-Type-2

Cardiovascular Outcomes in Patients With Type 2 Diabetes ... In patients with obesity and T2DM, RYGB may be associated with greater weight loss, better diabetes control, and lower risk of MACE and nephropathy compared ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0146280623005005

Impact of Bariatric Surgery on the Prevalence and ... This study focuses on the current trends regarding the impact of bariatric surgery on obese patients with atrial fibrillation.