Catheter Ablation vs. Medical Therapy in Congested Hearts With AF

Atrial Fibrillation Clinical Trial

— CATCH-AF  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02686749
• Other study ID #: Bio-858981
• Status: Terminated
• Phase: Phase 4
• Start date: June 2016
• Est. completion date: October 1, 2018

Study information

• Verified date: October 2018
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 220
• Est. completion date: October 1, 2018
• Est. primary completion date: July 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Congestive Heart Failure
• Heart Failure
• Left Ventricular Failure

Intervention

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.

Drug:
• FDA approved anti arrhythmic drug
Anti arrhythmic drug medical treatment will be based on treating physicians discretion following standard clinical guidelines

Locations

Country	Name	City	State
United States	Cleveland Clinic Akron General	Akron	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Hartford Hospital	Hartford	Connecticut
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Utah	Salt Lake City	Utah

Sponsors (3)

Lead Sponsor	Collaborator
Oussama Wazni	Biosense Webster, Inc., The Cleveland Clinic

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total number of cardiovascular hospitalization	total number of cardiovascular hospitalization measured by hospitalization admissions	15 months
Secondary	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
Secondary	Distance walked in a 6-mile walk test	change in distance walked in 6 mile walk test	3 months through 15 months
Secondary	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
Secondary	Change in Ejection Fraction (EF)	Change in Ejection Fraction heart failure measurement (percentage)	baseline through15 months