Atrial Fibrillation Clinical Trial
— CATCH-AFOfficial 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
Verified date | October 2018 |
Source | The Cleveland Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Oussama Wazni | Biosense Webster, Inc., The Cleveland Clinic |
United States,
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
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 |
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