Arrhythmia, Cardiac
Conditions
Brief summary
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.
Interventions
PROCEDURECatheter Ablation
Catheter ablation of atrial or ventricular arrhythmia. The technique and type of ablation will be at the discretion of the treating electrophysiologists.
DRUGAnti-Arrhythmics
Anti-Arrhythmic drugs that are deemed to be appropriate for the given participants's arrhythmia by the treating physician.
Sponsors
Biosense Webster, Inc.
Kansas City Heart Rhythm Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Ejection Fraction (EF) | 90 Days | Change in Ejection Fraction (EF) |
| Bi-ventricular Pacing Improvement | 90 Days | data not analyzed |
| Cardiovascular Mortality | 365Days | data not analyzed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Admissions for Heart Failure Exacerbation | 365 Days | data not analyzed |
| Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ) | 30 Days | data not analyzed |
| Change in 6 Minute Walk Test | 30 Days | data not analyzed |
| New York Heart Association (NYHA) Class Change | 30 Days | — |
| Change in Quality of Life - SF-36 | 30 Days | data not analyzed |
| All-cause Mortality | 365 Days | data was not analyzed |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Catheter Ablation Catheter ablation procedure of atrial and/or ventricular arrhythmias.
Catheter Ablation: Catheter ablation of atrial or ventricular arrhythmia. The technique and type of ablation will be at the discretion of the treating electrophysiologists. | 0 |
| Medical Therapy Medical management using antiarrhythmic drugs per standard of care of treating physician.
Anti-Arrhythmics: Anti-Arrhythmic drugs that are deemed to be appropriate for the given participants's arrhythmia by the treating physician. | 0 |
| Total | 0 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | study stopped due to PI leaving institut | 1 | 1 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Bi-ventricular Pacing Improvement
data not analyzed
Time frame: 90 Days
Population: data not analyzed
Primary
Cardiovascular Mortality
data not analyzed
Time frame: 365Days
Population: data not analyzed
Primary
Change in Ejection Fraction (EF)
Change in Ejection Fraction (EF)
Time frame: 90 Days
Population: data not analyzed
Secondary
All-cause Mortality
data was not analyzed
Time frame: 365 Days
Population: data not analyzed
Secondary
Change in 6 Minute Walk Test
data not analyzed
Time frame: 30 Days
Population: data not analyzed
Secondary
Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ)
data not analyzed
Time frame: 30 Days
Population: data not analyzed
Secondary
Change in Quality of Life - SF-36
data not analyzed
Time frame: 30 Days
Population: data not analyzed
Secondary
Hospital Admissions for Heart Failure Exacerbation
data not analyzed
Time frame: 365 Days
Population: data not analyzed
Secondary
New York Heart Association (NYHA) Class Change
Time frame: 30 Days
Population: data not analyzed