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

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

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.

Study Overview

• Status: Terminated
• Conditions: Atrial Fibrillation; Congestive Heart Failure; Left Ventricular Failure
• Intervention / Treatment: Device: Catheter Ablation; Drug: FDA approved anti arrhythmic drug

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
• Enrollment (Anticipated): 220
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Hospital
  • Ohio
    • Akron, Ohio, United States, 44307
      • Cleveland Clinic Akron General
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First hospitalization for heart failure, recurrence of AF or Direct Current cardioversion	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).	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total number of cardiovascular hospitalization	total number of cardiovascular hospitalization measured by hospitalization admissions	15 months
Time to recurrence if AF lasting longer than 30 seconds	time measured in days to recurrence of AF lasting longer than 30 seconds	15 months
Distance walked in a 6-mile walk test	change in distance walked in 6 mile walk test	3 months through 15 months
Change in the Rand 36-Item Health Survey	change in the Rand 36-Item Health Survey reflective of change in patient's quality of life	3 months through 15 months
Change in Ejection Fraction (EF)	Change in Ejection Fraction heart failure measurement (percentage)	baseline through15 months

Collaborators and Investigators

• Sponsor: Oussama Wazni
• Collaborators: The Cleveland Clinic; Biosense Webster, Inc.
• Investigators: Principal Investigator: Oussama Wazni, MD, The Cleveland Clinic

Publications and helpful links

General Publications

• Kannel WB, Abbott RD, Savage DD, McNamara PM. Epidemiologic features of chronic atrial fibrillation: the Framingham study. N Engl J Med. 1982 Apr 29;306(17):1018-22. doi: 10.1056/NEJM198204293061703.
• Van den Berg MP, Tuinenburg AE, Crijns HJ, Van Gelder IC, Gosselink AT, Lie KI. Heart failure and atrial fibrillation: current concepts and controversies. Heart. 1997 Apr;77(4):309-13. doi: 10.1136/hrt.77.4.309.
• Chen MS, Marrouche NF, Khaykin Y, Gillinov AM, Wazni O, Martin DO, Rossillo A, Verma A, Cummings J, Erciyes D, Saad E, Bhargava M, Bash D, Schweikert R, Burkhardt D, Williams-Andrews M, Perez-Lugones A, Abdul-Karim A, Saliba W, Natale A. Pulmonary vein isolation for the treatment of atrial fibrillation in patients with impaired systolic function. J Am Coll Cardiol. 2004 Mar 17;43(6):1004-9. doi: 10.1016/j.jacc.2003.09.056.
• Wyse DG. Some recent randomized clinical trials in the management of atrial fibrillation. J Interv Card Electrophysiol. 2003 Oct;9(2):223-8. doi: 10.1023/a:1026292609252.
• Corley SD, Epstein AE, DiMarco JP, Domanski MJ, Geller N, Greene HL, Josephson RA, Kellen JC, Klein RC, Krahn AD, Mickel M, Mitchell LB, Nelson JD, Rosenberg Y, Schron E, Shemanski L, Waldo AL, Wyse DG; AFFIRM Investigators. Relationships between sinus rhythm, treatment, and survival in the Atrial Fibrillation Follow-Up Investigation of Rhythm Management (AFFIRM) Study. Circulation. 2004 Mar 30;109(12):1509-13. doi: 10.1161/01.CIR.0000121736.16643.11. Epub 2004 Mar 8.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): July 19, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: February 5, 2016
• First Submitted That Met QC Criteria: February 18, 2016
• First Posted (Estimate): February 19, 2016

Study Record Updates

• Last Update Posted (Actual): October 25, 2018
• Last Update Submitted That Met QC Criteria: October 23, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Failure; Atrial Fibrillation; Anti-Arrhythmia Agents
• Other Study ID Numbers: Bio-858981

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No