Clinical trial NCT02686749: Catheter Ablation vs. Medical Therapy in Congested Hearts With 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Congestive Heart Failure
Left Ventricular Failure
Atrial Fibrillation
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Biosense Webster, Inc.
First posted: 2016-02-19
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: First Hospitalization for Heart Failure, Recurrence of AF or Direct Current Cardioversion
timeFrame: 12 months
Secondary outcomes:
measure: Total Number of Cardiovascular Hospitalization
timeFrame: 15 months
measure: Time to Recurrence if AF Lasting Longer Than 30 Seconds
timeFrame: 15 months
measure: Distance Walked in a 6-mile Walk Test
timeFrame: 3 months through 15 months
measure: Change in the Rand 36-Item Health Survey
timeFrame: 3 months through 15 months
measure: Change in Ejection Fraction (EF)
timeFrame: baseline through15 months
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Akron
country: United States
facility: Cleveland Clinic Akron General
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: The Cleveland Clinic
name: Oussama Wazni, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1056/NEJM198204293061703.
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. doi: 10.1136/hrt.77.4.309.
citation: 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.
citation: 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.
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. doi: 10.1161/01.CIR.0000121736.16643.11. Epub 2004 Mar 8.