Catheter Ablation of Arrhythmias to Improve CRT Response

Study Overview
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Brief Summary
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The purpose of this study is to test if catheter ablation is better than medication therapy at treating arrhythmias originating from the upper and/or lower chambers of the heart in order to allow the heart to beat properly.

Official Title
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Catheter Ablation of Arrhythmias to Improve CRT Response

Conditions
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Arrhythmia, Cardiac

Intervention / Treatment
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* Procedure: Catheter Ablation
* Drug: Anti-Arrhythmics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Heart failure patients with CRT-D or CRT-P greater than 3 months Bi-ventricular pacing less than 94% of the time 3 months after CRT-D or CRT-P implantation an EF improvement less than 5% Presence of one of the following arrhythmias and eligible for catheter ablation: Atrial fibrillation Atrial flutter Supraventricular tachycardia Premature ventricular contraction burden greater than 30% in a 24-hour period Ventricular tachycardia Exclusion Criteria: Estimated survival less than one year Patient unable to make scheduled follow up visits at treating center Participating in another investigational study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Catheter Ablation<br>Catheter ablation procedure of atrial and/or ventricular arrhythmias. | Procedure: Catheter Ablation<br>* Catheter ablation of atrial or ventricular arrhythmia. The technique and type of ablation will be at the discretion of the treating electrophysiologists.<br>|
| Active Comparator: Medical Therapy<br>Medical management using antiarrhythmic drugs per standard of care of treating physician. | Drug: Anti-Arrhythmics<br>* Anti-Arrhythmic drugs that are deemed to be appropriate for the given participants's arrhythmia by the treating physician.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Ejection Fraction (EF) | Change in Ejection Fraction (EF) | 90 Days | 
| Bi-ventricular Pacing Improvement | data not analyzed | 90 Days | 
| Cardiovascular Mortality | data not analyzed | 365Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause Mortality | data was not analyzed | 365 Days | 
| Hospital Admissions for Heart Failure Exacerbation | data not analyzed | 365 Days | 
| New York Heart Association (NYHA) Class Change |  | 30 Days | 
| Change in 6 Minute Walk Test | data not analyzed | 30 Days | 
| Change in Quality of Life - SF-36 | data not analyzed | 30 Days | 
| Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ) | data not analyzed | 30 Days |