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Catheter Ablation vs. Medical Therapy in Congested Hearts With AF (CATCH-AF)

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ClinicalTrials.gov Identifier: NCT02686749
Recruitment Status : Recruiting
First Posted : February 19, 2016
Last Update Posted : September 5, 2017
Biosense Webster, Inc.
The Cleveland Clinic
Information provided by (Responsible Party):
Oussama Wazni, The Cleveland Clinic

Brief Summary:
This study is a multi-center, randomized, unblinded, clinical trial. The objective is to determine if catheter-based atrial fibrillation (AF) ablation is superior to medical treatment in patients with impaired left ventricular (LV) function who have been diagnosed with symptomatic AF within the past 12 months.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Left Ventricular Failure Atrial Fibrillation Device: Catheter Ablation Drug: FDA approved anti arrhythmic drug Phase 4

Detailed Description:
The purpose of the trial is to compare two different approved treatments for recently diagnosed AF: anti-arrhythmic medications and AF ablation. The study will be conducted to determine if one treatment is more effective than the other for patients with AF and heart failure. About 220 subjects with newly diagnosed AF from hospitals in the United States will take part in this study. Subjects will be randomized in a 1:1 fashion to either AF catheter ablation or anti-arrhythmic medication for treatment of AF. Both therapies are considered Standard of Care.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Study randomizes subjects to already FDA approved treatment modalities. Approved anti-arrhythmic medications or AF ablation. There are no investigational drug or devices used.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Catheter Ablation vs. Medical Therapy in Congested Hearts With AF (CATCH-AF in Patients With Impaired LV Function): An Early Ablation Strategy Study Impact on Health Care Utilization
Study Start Date : June 2016
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: AF catheter Ablation
Pulmonary Vein Isolation catheter ablation for treatment of AF. AF catheter ablation is an FDA approved treatment for AF
Device: Catheter Ablation
During ablation, a doctor inserts a catheter through blood vessels into the heart. The doctor looks at the electrical activity of the heart. The catheter is used to determine which areas of the heart are causing AF. After the area is identified, the doctor uses a special machine delivers energy through the catheter to tiny areas of the heart muscle that is causing AF. This energy causes a scar in the tissue which "disconnects" the pathway of the AF.
Other Name: Pulmonary Vein Isolation
Active Comparator: FDA approved anti arrhythmic drug
FDA approved anti arrhythmic drug for the treatment of AF will be based on treating physicians' preference in accordance to guidelines.
Drug: FDA approved anti arrhythmic drug
Anti arrhythmic drug medical treatment will be based on treating physicians discretion following standard clinical guidelines

Primary Outcome Measures :
  1. First hospitalization for heart failure, recurrence of AF or Direct Current cardioversion [ Time Frame: 12 months ]
    Time measured in days to first hospitalization for heart failure, recurrence of AF or Direct Current cardioversion after the treatment period (first 3 months post enrollment or post procedure during which repeat ablation can be performed and titration of AADs can be performed).

Secondary Outcome Measures :
  1. Total number of cardiovascular hospitalization [ Time Frame: 15 months ]
    total number of cardiovascular hospitalization measured by hospitalization admissions

  2. Time to recurrence if AF lasting longer than 30 seconds [ Time Frame: 15 months ]
    time measured in days to recurrence of AF lasting longer than 30 seconds

  3. Distance walked in a 6-mile walk test [ Time Frame: 3 months through 15 months ]
    change in distance walked in 6 mile walk test

  4. Change in the Rand 36-Item Health Survey [ Time Frame: 3 months through 15 months ]
    change in the Rand 36-Item Health Survey reflective of change in patient's quality of life

  5. Change in Ejection Fraction (EF) [ Time Frame: baseline through15 months ]
    Change in Ejection Fraction heart failure measurement (percentage)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • must be 18 years of age or older
  • Provide signed written Informed Consent
  • symptomatic AF documented by EKG or heart rhythm monitoring within 12 months
  • patients should be on optimal medical therapy for heart failure for 3 months prior to randomization. Adjustments to medications within this 3 month period are permitted.
  • chronically impaired LV function defined as EF between 20%-45% within last 3 months
  • all patients should be on an optimal therapy for impaired LV function
  • ability to complete 6 minute walk test
  • eligible for catheter ablation and anti-arrhythmic drugs

Exclusion Criteria:

  • women of childbearing potential unless post- menopausal or surgically sterile
  • patients hospitalized for heart failure within the 3 months prior to randomization
  • reversible causes of AF such as pericarditis, thyroid disorders, acute alcohol intoxication, recent major surgical procedures or trauma
  • recent reversible LV impairment that may be attributed to AF with rapid ventricular response and may improve with introduction of rate control
  • valvular heart disease requiring surgical intervention
  • Coronary Artery Disease (CAD) requiring surgical or percutaneous intervention
  • early post-operative AF (within 3 months of surgery)
  • previous MAZE or left atrial instrumentation (including ablation and left atrial appendage exclusion)
  • history of Atrioventricular Node (AVN) ablation
  • hypertrophic cardiomyopathy
  • prolonged QT interval
  • liver failure
  • renal failure requiring dialysis
  • social factors that would preclude follow up or make compliance difficult- history of drug, alcohol or substance abuse
  • contraindications to the use of AADs and/or anticoagulation therapy
  • Currently enrolled in, or discontinued within the last 30 days from a clinical trial involving an investigational product or non-approved use of a drug or device or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
  • severe pulmonary disease
  • documented intra-atrial thrombus, tumor, or structural abnormality which precludes catheter introduction
  • unwilling to comply with protocol requirements or deemed by the investigator to be unfit for the study.

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): NCT02686749

Contact: Allison D Kirkholder, BSN 216-445-8070 kirkhoa@ccf.org

United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102
Contact: Edmond M Cronin, MD    860-972-1506    edmond.cronin@hhchealth.org   
Contact: Deborah M Katten, RN    860-972-1537    Deborah.katten@hhchealth.org   
United States, Ohio
Cleveland Clinic Akron General Recruiting
Akron, Ohio, United States, 44307
Contact: Robert Schweikert, MD    330-344-4377    Robert.schweikert@akrongeneral.org   
Contact: Tonya Frederick, MSN    330-344-1430    Tonya.frederick@akrongeneral.org   
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Oussama Wazni, MD    216-444-6697    waznio@ccf.org   
Contact: Melanie Panko, RN    216-444-6478    pankom@ccf.org   
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Mahmoud Houmsse, MD    614-293-4967    Mahmoud.Houmsse@osumc.edu   
Contact: Jennifer Smith, RN    614-685-4624    Jennifer.Smith6@osumc.edu   
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Gregory Supple, MD    215-615-3811    Gregory.supple@uphs.upenn.edu   
Contact: Mary Gnap, RN    215 349 8446    Mary.gnap@uphs.upenn.edu   
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Nassir Marrouche, MD    801-581-2572    Nassir.marrouche@hsc.utah.edu   
Contact: Katt Mackin    801-581-7287    Katt.mackin@hsc.utah.edu   
Sponsors and Collaborators
Oussama Wazni
Biosense Webster, Inc.
The Cleveland Clinic
Principal Investigator: Oussama Wazni, MD The Cleveland Clinic

Responsible Party: Oussama Wazni, Professor of Medicine, Co-Director of AF and VT Centers, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02686749     History of Changes
Other Study ID Numbers: Bio-858981
First Posted: February 19, 2016    Key Record Dates
Last Update Posted: September 5, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Heart Failure
Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Anti-Arrhythmia Agents