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Trial record 93 of 601 for:    "Obesity, Morbid"

Catheter Ablation With or Without Bariatric Surgery In Patients With Atrial Fibrillation and Morbid Obesity

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ClinicalTrials.gov Identifier: NCT04050969
Recruitment Status : Not yet recruiting
First Posted : August 9, 2019
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
Paul Wang, Stanford University

Brief 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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Morbid Obesity Procedure: Bariatric surgery Procedure: Atrial Fibrillation (AF) Catheter Ablation Not Applicable

Detailed Description:

This will be a multicenter, randomized, controlled, 1:1 allocation trial comparing bariatric surgery followed by Atrial Fibrillation (AF) catheter ablation (BS group) 6 months later or AF catheter ablation only (CA group) among patients with paroxysmal or persistent AF and morbid obesity.

Participants will be followed for 12 months after their protocol-assigned catheter ablation. Scheduled visits in the CA group will be at baseline, 3, 6, and 12 months post AF ablation. Scheduled visits in the BS group 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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 534 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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. If collaborative sites are included, 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)
Primary Purpose: Treatment
Official Title: Catheter Ablation With or Without Bariatric Surgery In Patients With Atrial Fibrillation and Morbid Obesity
Estimated Study Start Date : August 15, 2019
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bariatric surgery plus AF Catheter Ablation

Participants will undergo either a laparoscopic sleeve gastrectomy or laparoscopic Roux-en-Y gastric bypass. 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.

Procedure: Bariatric surgery
Participants will undergo either a laparoscopic sleeve gastrectomy or laparoscopic Roux-en-Y gastric bypass.

Procedure: Atrial Fibrillation (AF) Catheter Ablation
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.

Active Comparator: Atrial Fibrillation (AF) Catheter Ablation
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.
Procedure: Atrial Fibrillation (AF) Catheter Ablation
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in AF Burden off anti-arrhythmic agents monitor [ Time Frame: Baseline (Initial), 3 months) ]
    The percentage of time in AF burden on the cardiac monitor will be calculated

  2. Change in AF Burden off anti-arrhythmic agents monitor [ Time Frame: Baseline (Initial), 6 months) ]
    The percentage of time in AF burden on the cardiac monitor will be calculated

  3. Change in AF Burden off anti-arrhythmic agents monitor [ Time Frame: Baseline (Initial), 12 months) ]
    The percentage of time in AF burden on the cardiac monitor will be calculated

  4. Change from Baseline in AF Quality of Life Score [ Time Frame: Baseline (Initial), 3 months ]
    Quality of Life will be assessed using a patient completed questionnaire, Atrial Fibrillation Effect on Quality of Life Questionnaire. The AFEQT score is a combined score of 21 items (21-100) with a higher score representing greater QOL

  5. Change from Baseline in AF Quality of Life Score [ Time Frame: Baseline (Initial), 6 months ]
    Quality of Life will be assessed using a patient completed questionnaire, Atrial Fibrillation Effect on Quality of Life Questionnaire. The AFEQT score is a combined score of 21 items (21-100) with a higher score representing greater QOL

  6. Change from Baseline in AF Quality of Life Score [ Time Frame: Baseline (Initial), 12 months ]
    Quality of Life will be assessed using a patient completed questionnaire, Atrial Fibrillation Effect on Quality of Life Questionnaire. The AFEQT score is a combined score of 21 items (21-100) with a higher score representing greater QOL

  7. Change from Baseline in AF symptom severity [ Time Frame: Baseline (Initial), 3 months ]
    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

  8. Change from Baseline in AF symptom severity [ Time Frame: Baseline (Initial), 6 months ]
    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

  9. Change from Baseline in AF symptom severity [ Time Frame: Baseline (Initial), 12 months ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptomatic persistent or paroxysmal AF refractory to at least one antiarrhythmic agent
  • EF > 40%
  • BMI > 40 or BMI > 35 and at least two 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).
    • 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.

Exclusion Criteria:

  • Prior bariatric surgery or AF catheter ablation
  • BMI > 60 kg/m2
  • Contraindication to bariatric surgery or AF ablation
  • Contraindication to therapeutic anticoagulation
  • Sustained AF lasting more than 3 years
  • Left atrial diameter of 60 mm or greater or LA volume > 60 ml/m2

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04050969


Contacts
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Contact: Linda K Ottoboni, PhD 650-498-5914 lottoboni@stanfordhealthcare.org
Contact: Gerri O'Riordan, RN 650-725-5597 gor@stanford.edu

Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Paul J Wang, MD Director Stanford Electrophysiology and Arrhythmia Service, Stanford University
Principal Investigator: Dan E Azagury, MD Assistant Professor of Surgery, Bariatric & Minimally Invasive Surgery

Publications:

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Responsible Party: Paul Wang, Director, Stanford Electrophysiology and Arrhythmia Service, Stanford University
ClinicalTrials.gov Identifier: NCT04050969     History of Changes
Other Study ID Numbers: ID # 49225
First Posted: August 9, 2019    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity, Morbid
Atrial Fibrillation
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes