TerminatedNCT02686749CATCH-AFUpdated Jun 5, 2025Results posted

Catheter Ablation vs. Medical Therapy in Congested Hearts With AF

A Phase 4 interventional study of Catheter Ablation and FDA approved anti arrhythmic drug in Congestive Heart Failure, Left Ventricular Failure and Atrial Fibrillation, sponsored by The Cleveland Clinic. Terminated at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-05.

Sponsored by The Cleveland Clinic · Phase 4, Interventional, and Treatment

Why this study was terminated

unable to reach enrollment goal

Phase: Phase 4
Study type: Interventional
Enrollment: 4
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Congestive Heart Failure
Left Ventricular Failure
Atrial Fibrillation

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In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 4 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.

Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: 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

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 design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 4 participants (actual)

Study arms

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
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

Interventions

DeviceCatheter 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.
Also known as: Pulmonary Vein Isolation
DrugFDA approved anti arrhythmic drug
Anti arrhythmic drug medical treatment will be based on treating physicians discretion following standard clinical guidelines

What researchers measure

Primary outcomes

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).
Time frame: 12 months

Secondary outcomes

Total Number of Cardiovascular Hospitalization
total number of cardiovascular hospitalization measured by hospitalization admissions
Time frame: 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
Time frame: 15 months
Distance Walked in a 6-mile Walk Test
change in distance walked in 6 mile walk test
Time frame: 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
Time frame: 3 months through 15 months
Change in Ejection Fraction (EF)
Change in Ejection Fraction heart failure measurement (percentage)
Time frame: baseline through15 months

Results

Posted Jun 5, 2025

Limitations and caveats

Trial terminated due to poor enrollment. No subjects completed study. Did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.

Participant flow

Participant flow — Overall Study
Milestone	AF Catheter Ablation	FDA Approved Anti Arrhythmic Drug
Started	2	2
Completed	0	0
Not completed	2	2
Withdrew: Terminated for poor enrollment	2	2

Outcome measures

PrimaryFirst 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).

Time frame:: 12 months