Atrial FibrillationBAROSNCT04050969
Bariatric Atrial Restoration of Sinus Rhythm
A study testing Bariatric surgery and Atrial Fibrillation (AF) Catheter Ablation in people with Atrial Fibrillation and Morbid Obesity, run by Stanford University at 1 site in United States.
Trial summary
The objective of this study is to determine whether bariatric surgery followed by Atrial Fibrillation (AF) catheter ablation is superior to AF catheter ablation alone in the management of atrial fibrillation in patients with morbid obesity. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atrial Fibrillation, Morbid Obesity
- What is being tested?
- Bariatric surgery and Atrial Fibrillation (AF) Catheter Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Show all 16Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to determine whether bariatric surgery followed by Atrial Fibrillation (AF) catheter ablation is superior to AF catheter ablation alone in the management of atrial fibrillation in patients with morbid obesity.
Read the detailed description
This will be a multicenter, randomized, controlled, 1:1 allocation trial comparing Atrial Fibrillation (AF) catheter ablation only (Group A) to those undergoing bariatric surgery six months prior to AF catheter ablation (Group B) in patients with paroxysmal or persistent AF who also have morbid obesity.
Participants will be followed for 12 months after their protocol-assigned catheter ablation. Scheduled visits Group A will be at baseline, 3, 6, and 12 months post AF ablation. Scheduled visits in Group B will be baseline, clinical visit prior AF ablation, and at 3, 6, and 12 months post AF ablation. At each post ablation visit the following data will be collected:
AT/AF recurrence determined by ambulatory monitoring, clinic visit, or hospitalization; Physical Exam (weight, height, vitals); 12 lead ECG; Medication Regimen; AF Symptom Severity Scale (AFSS); Quality of Life (AFEQT); Laboratory Testing; and Adverse Events
- Conditions
- Atrial Fibrillation, Morbid Obesity
- Being tested
- Bariatric surgery, Atrial Fibrillation (AF) Catheter Ablation
- Medical subject headings
- Atrial Fibrillation, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
Participants will undergo either a laparoscopic sleeve gastrectomy or laparoscopic Roux-en-Y gastric bypass.
Atrial Fibrillation (AF) Catheter AblationProcedure or surgery
Participants will undergo catheter ablation using either radiofrequency or cryoablation of pulmonary veins. Participants with persistent AF may also undergo roof and/or floor linear ablation with or without ablation of extrapulmonary sites at the physician's discretion.
| Study group | Role | What they receive |
|---|---|---|
| Atrial Fibrillation (AF) Catheter Ablation-Group A | Active comparator | Participants will undergo catheter ablation using either radiofrequency or cryo-ablation of pulmonary veins. Participants with persistent AF may also undergo roof and/or floor linear ablation with or without ablation of extra-pulmonary sites at the physician's discretion. Receives: Procedure: Atrial Fibrillation (AF) Catheter Ablation |
| Bariatric surgery prior to AF Catheter Ablation-Group B | Experimental | Participants will undergo either a Roux-en-Y gastric bypass or a laparoscopic sleeve gastrectomy. The choice of the procedure will be based on numerous factors including current practice, the surgeon's and participant's choice, BMI, and the presence of certain comorbidities and their severity such as GERD, kidney stones, and past surgical history. Participants will undergo standard preoperative evaluation including dietary consultation and psychological evaluation during the eligibility process.
After bariatric surgery, in addition to routine post-surgical management, patients will follow up with cardiologist prior to AF catheter ablation. Receives: Procedure: Bariatric surgery; Procedure: Atrial Fibrillation (AF) Catheter Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first recurrence of AF following a 3-month blanking period after the ablation.
The primary outcome measure will be time to first recurrence of any atrial arrhythmia including AF, atrial flutter, or atrial tachycardia lasting longer than 30 seconds and occurring more than 3 months after AF ablation, without the use of antiarrhythmic medications. An episode of AF or atrial tachycardia will be considered part of the primary outcome analysis if it lasts longer than 30 seconds and is documented by any form of electrocardiographic monitoring, regardless of symptoms. A repeat catheter ablation procedure at any time will constitute a recurrence for the outcome analysis.
Measured: Time to first recurrence of AF following a 3-month blanking period after the AF Catheter ablation.
Secondary outcomes (7)
Change in AF Burden off anti-arrhythmic agents monitor
The percentage of time in AF burden on the cardiac monitor will be calculated
Measured: Baseline (Initial), 3 months)
Change in AF Burden off anti-arrhythmic agents monitor
The percentage of time in AF burden on the cardiac monitor will be calculated
Measured: Baseline (Initial), 6 months)
Change in AF Burden off anti-arrhythmic agents monitor
The percentage of time in AF burden on the cardiac monitor will be calculated
Measured: Baseline (Initial), 12 months)
Change from Baseline in AF Quality of Life Score
Quality of Life will be assessed using a patient completed questionnaire, Cardiff Cardiac Ablation Patient Reported Outcome Measure (C-CAP) Questionnaire, pre-ablation (C-CAP1) and post ablation (C-CAP-2). The C-CAP score is a combined score of 16-18 items (0-30) with a higher score representing greater QOL.
Measured: Baseline (Initial), 6 months
Change from Baseline in AF Quality of Life Score
Quality of Life will be assessed using a patient completed questionnaire, Cardiff Cardiac Ablation Patient Reported Outcome Measure (C-CAP) Questionnaire, pre-ablation (C-CAP1) and post ablation (C-CAP-2). The C-CAP score is a combined score of 16-18 items (0-30) with a higher score representing greater QOL.
Measured: Baseline (Initial), 12 months
Change from Baseline in AF symptom severity
AF symptom burden will be assessed with the Atrial Fibrillation Symptoms Severity Scale. The AFSS is a patient self-reported questionnaire that contains 21 questions with 7 questions providing a calculated scores for AF symptom severity (0-35) with higher scores representing greater severity.
Measured: Baseline (Initial), 6 months
Change from Baseline in AF symptom severity
AF symptom burden will be assessed with the Atrial Fibrillation Symptoms Severity Scale. The AFSS is a patient self-reported questionnaire that contains 21 questions with 7 questions providing a calculated scores for AF symptom severity (0-35) with higher scores representing greater severity.
Measured: Baseline (Initial), 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start1 Oct 2020
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Why it stopped: Difficult enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will undergo screening and eligibility to make sure they meet all criteria for the trial. If patients meet all defined criteria, they will undergo informed consent and will be randomized with equal allocation to the catheter ablation only and bariatric surgery plus AF catheter ablation arms. Randomization will be stratified by site and type of AF (paroxysmal or persistent) using permuted blocks to limit effects of clinician variation.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Wang, Stanford University
- Investigators
- Paul J Wang, MD, Principal investigator, Director Stanford Electrophysiology and Arrhythmia Service, Stanford UniversityDan E Azagury, MD, Principal investigator, Assistant Professor of Surgery, Bariatric & Minimally Invasive Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04050969
- Sponsor's protocol ID
- ID # 49225
- Acronym
- BAROS
- Status last verified
- Oct 2022
- First submitted
- 7 Aug 2019
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lavie CJ, Pandey A, Lau DH, Alpert MA, Sanders P. Obesity and Atrial Fibrillation Prevalence, Pathogenesis, and Prognosis: Effects of Weight Loss and Exercise. J Am Coll Cardiol. 2017 Oct 17;70(16):2022-2035. doi: 10.1016/j.jacc.2017.09.002.
PubMed 29025560January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2014 Dec 2;64(21):e1-76. doi: 10.1016/j.jacc.2014.03.022. Epub 2014 Mar 28. No abstract available.
PubMed 24685669Abed HS, Wittert GA, Leong DP, Shirazi MG, Bahrami B, Middeldorp ME, Lorimer MF, Lau DH, Antic NA, Brooks AG, Abhayaratna WP, Kalman JM, Sanders P. Effect of weight reduction and cardiometabolic risk factor management on symptom burden and severity in patients with atrial fibrillation: a randomized clinical trial. JAMA. 2013 Nov 20;310(19):2050-60. doi: 10.1001/jama.2013.280521.
PubMed 24240932Middeldorp ME, Pathak RK, Meredith M, Mehta AB, Elliott AD, Mahajan R, Twomey D, Gallagher C, Hendriks JML, Linz D, McEvoy RD, Abhayaratna WP, Kalman JM, Lau DH, Sanders P. PREVEntion and regReSsive Effect of weight-loss and risk factor modification on Atrial Fibrillation: the REVERSE-AF study. Europace. 2018 Dec 1;20(12):1929-1935. doi: 10.1093/europace/euy117.
PubMed 29912366
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bariatric Atrial Restoration of Sinus Rhythm
- ClinicalTrials.gov ID
- NCT04050969
- Acronym / sponsor ID
- BAROS / ID # 49225
- Conditions
- Atrial Fibrillation, Morbid Obesity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficult enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 9 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine whether bariatric surgery followed by Atrial Fibrillation (AF) catheter ablation is superior to AF catheter ablation alone in the management of atrial fibrillation in patients with morbid obesity.
Detailed description
This will be a multicenter, randomized, controlled, 1:1 allocation trial comparing Atrial Fibrillation (AF) catheter ablation only (Group A) to those undergoing bariatric surgery six months prior to AF catheter ablation (Group B) in patients with paroxysmal or persistent AF who also have morbid obesity.
Participants will be followed for 12 months after their protocol-assigned catheter ablation. Scheduled visits Group A will be at baseline, 3, 6, and 12 months post AF ablation. Scheduled visits in Group B will be baseline, clinical visit prior AF ablation, and at 3, 6, and 12 months post AF ablation. At each post ablation visit the following data will be collected:
AT/AF recurrence determined by ambulatory monitoring, clinic visit, or hospitalization; Physical Exam (weight, height, vitals); 12 lead ECG; Medication Regimen; AF Symptom Severity Scale (AFSS); Quality of Life (AFEQT); Laboratory Testing; and Adverse Events
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will undergo screening and eligibility to make sure they meet all criteria for the trial. If patients meet all defined criteria, they will undergo informed consent and will be randomized with equal allocation to the catheter ablation only and bariatric surgery plus AF catheter ablation arms. Randomization will be stratified by site and type of AF (paroxysmal or persistent) using permuted blocks to limit effects of clinician variation.
| Arm | Type | Receives |
|---|---|---|
| Atrial Fibrillation (AF) Catheter Ablation-Group A | Active comparator | Procedure: Atrial Fibrillation (AF) Catheter AblationParticipants will undergo catheter ablation using either radiofrequency or cryo-ablation of pulmonary veins. Participants with persistent AF may also undergo roof and/or floor linear ablation with or without ablation of extra-pulmonary sites at the physician's discretion. |
| Bariatric surgery prior to AF Catheter Ablation-Group B | Experimental | Procedure: Bariatric surgery, Procedure: Atrial Fibrillation (AF) Catheter AblationParticipants will undergo either a Roux-en-Y gastric bypass or a laparoscopic sleeve gastrectomy. The choice of the procedure will be based on numerous factors including current practice, the surgeon's and participant's choice, BMI, and the presence of certain comorbidities and their severity such as GERD, kidney stones, and past surgical history. Participants will undergo standard preoperative evaluation including dietary consultation and psychological evaluation during the eligibility process. After bariatric surgery, in addition to routine post-surgical management, patients will follow up with cardiologist prior to AF catheter ablation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
Key exclusion criteria (7 listed)
- Prior bariatric surgery
- Prior AF catheter ablation
- BMI > 65 kg/m2
- Contraindication to bariatric surgery or AF ablation
- Contraindication to therapeutic anticoagulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bariatric surgeryParticipants will undergo either a laparoscopic sleeve gastrectomy or laparoscopic Roux-en-Y gastric bypass. | Procedure or surgery | Bariatric surgery prior to AF Catheter Ablation-Group B |
| Atrial Fibrillation (AF) Catheter AblationParticipants will undergo catheter ablation using either radiofrequency or cryoablation of pulmonary veins. Participants with persistent AF may also undergo roof and/or floor linear ablation with or without ablation of extrapulmonary sites at the physician's discretion. | Procedure or surgery | Atrial Fibrillation (AF) Catheter Ablation-Group A, Bariatric surgery prior to AF Catheter Ablation-Group B |
Primary outcome
Time to first recurrence of AF following a 3-month blanking period after the ablation.
Time frame: Time to first recurrence of AF following a 3-month blanking period after the AF Catheter ablation.
The primary outcome measure will be time to first recurrence of any atrial arrhythmia including AF, atrial flutter, or atrial tachycardia lasting longer than 30 seconds and occurring more than 3 months after AF ablation, without the use of antiarrhythmic medications. An episode of AF or atrial tachycardia will be considered part of the primary outcome analysis if it lasts longer than 30 seconds and is documented by any form of electrocardiographic monitoring, regardless of symptoms. A repeat catheter ablation procedure at any time will constitute a recurrence for the outcome analysis.
7 secondary outcomes
Change in AF Burden off anti-arrhythmic agents monitor
Time frame: Baseline (Initial), 3 months)
Change in AF Burden off anti-arrhythmic agents monitor
Time frame: Baseline (Initial), 6 months)
Change in AF Burden off anti-arrhythmic agents monitor
Time frame: Baseline (Initial), 12 months)
Change from Baseline in AF Quality of Life Score
Time frame: Baseline (Initial), 6 months
Change from Baseline in AF Quality of Life Score
Time frame: Baseline (Initial), 12 months
Change from Baseline in AF symptom severity
Time frame: Baseline (Initial), 6 months
Change from Baseline in AF symptom severity
Time frame: Baseline (Initial), 12 months
Results and safety
The study was stopped early (reason given: Difficult enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
- Background: PubMed 29025560Lavie CJ, Pandey A, Lau DH, Alpert MA, Sanders P. Obesity and Atrial Fibrillation Prevalence, Pathogenesis, and Prognosis: Effects of Weight Loss and Exercise. J Am Coll Cardiol. 2017 Oct 17;70(16):2022-2035. doi: 10.1016/j.jacc.2017.09.002.
- Background: PubMed 24685669January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2014 Dec 2;64(21):e1-76. doi: 10.1016/j.jacc.2014.03.022. Epub 2014 Mar 28. No abstract available.
- Background: PubMed 24240932Abed HS, Wittert GA, Leong DP, Shirazi MG, Bahrami B, Middeldorp ME, Lorimer MF, Lau DH, Antic NA, Brooks AG, Abhayaratna WP, Kalman JM, Sanders P. Effect of weight reduction and cardiometabolic risk factor management on symptom burden and severity in patients with atrial fibrillation: a randomized clinical trial. JAMA. 2013 Nov 20;310(19):2050-60. doi: 10.1001/jama.2013.280521.
- Background: PubMed 29912366Middeldorp ME, Pathak RK, Meredith M, Mehta AB, Elliott AD, Mahajan R, Twomey D, Gallagher C, Hendriks JML, Linz D, McEvoy RD, Abhayaratna WP, Kalman JM, Lau DH, Sanders P. PREVEntion and regReSsive Effect of weight-loss and risk factor modification on Atrial Fibrillation: the REVERSE-AF study. Europace. 2018 Dec 1;20(12):1929-1935. doi: 10.1093/europace/euy117.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul J Wang, MD principal investigator
Director Stanford Electrophysiology and Arrhythmia Service, Stanford University
Dan E Azagury, MD principal investigator
Assistant Professor of Surgery, Bariatric & Minimally Invasive Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bariatric surgery and Atrial Fibrillation (AF) Catheter Ablation in people with Atrial Fibrillation and Morbid Obesity, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficult enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first recurrence of AF following a 3-month blanking period after the ablation. (time frame: Time to first recurrence of AF following a 3-month blanking period after the AF Catheter ablation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04050969, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2022; AzTrials last refreshed its copy on 7 Nov 2026.