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

• Sponsor: Oussama Wazni (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02686749
• Collaborator: Biosense Webster, Inc. (Industry), The Cleveland Clinic (Other)
• Enrollment: 220
• Locations: 6
• Arms: 2
• Duration (Months): 28
• Patients Per Site: 36.7
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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 Design

• Study Type: Interventional
• Anticipated 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.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: Jun 1, 2016
• Actual Primary Completion Date: Jul 19, 2018
• Actual Study Completion Date: Oct 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. First hospitalization for heart failure, recurrence of AF or Direct Current cardioversion [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 [15 months]

   total number of cardiovascular hospitalization measured by hospitalization admissions

2. Time to recurrence if AF lasting longer than 30 seconds [15 months]

   time measured in days to recurrence of AF lasting longer than 30 seconds

3. Distance walked in a 6-mile walk test [3 months through 15 months]

   change in distance walked in 6 mile walk test

4. Change in the Rand 36-Item Health Survey [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) [baseline through15 months]

   Change in Ejection Fraction heart failure measurement (percentage)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hartford Hospital	Hartford	Connecticut	United States	06102
2	Cleveland Clinic Akron General	Akron	Ohio	United States	44307
3	Cleveland Clinic	Cleveland	Ohio	United States	44195
4	The Ohio State University Wexner Medical Center	Columbus	Ohio	United States	43210
5	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
6	University of Utah	Salt Lake City	Utah	United States	84132

Sponsors and Collaborators

• Oussama Wazni
• Biosense Webster, Inc.
• The Cleveland Clinic

Investigators

• Principal Investigator: Oussama Wazni, MD, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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. Epub 2004 Mar 8.
• 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.
• 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. Review.
• Wyse DG. Some recent randomized clinical trials in the management of atrial fibrillation. J Interv Card Electrophysiol. 2003 Oct;9(2):223-8. Review.

• Responsible Party: Oussama Wazni, Professor of Medicine, Co-Director of AF and VT Centers, The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT02686749
• Other Study ID Numbers: Bio-858981
• First Posted: Feb 19, 2016
• Last Update Posted: Oct 25, 2018
• Last Verified: Oct 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Heart Failure; Atrial Fibrillation; Anti-Arrhythmia Agents

Study Results

No Results Posted as of Oct 25, 2018