Atrial Fibrillation, Congestive Heart Failure, Left Ventricular Failure
Conditions
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.
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.
DRUGFDA approved anti arrhythmic drug
Anti arrhythmic drug medical treatment will be based on treating physicians discretion following standard clinical guidelines
Sponsors
Biosense Webster, Inc.
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First Hospitalization for Heart Failure, Recurrence of AF or Direct Current Cardioversion | 12 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Cardiovascular Hospitalization | 15 months | total number of cardiovascular hospitalization measured by hospitalization admissions |
| Time to Recurrence if AF Lasting Longer Than 30 Seconds | 15 months | time measured in days to recurrence of AF lasting longer than 30 seconds |
| Distance Walked in a 6-mile Walk Test | 3 months through 15 months | change in distance walked in 6 mile walk test |
| Change in the Rand 36-Item Health Survey | 3 months through 15 months | change in the Rand 36-Item Health Survey reflective of change in patient's quality of life |
| Change in Ejection Fraction (EF) | baseline through15 months | Change in Ejection Fraction heart failure measurement (percentage) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AF Catheter Ablation Pulmonary Vein Isolation catheter ablation for treatment of AF. AF catheter ablation is an FDA approved treatment for AF
Catheter 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. | 2 |
| 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.
FDA approved anti arrhythmic drug: Anti arrhythmic drug medical treatment will be based on treating physicians discretion following standard clinical guidelines | 2 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | terminated for poor enrollment | 2 | 2 |
Baseline characteristics
| Characteristic | AF Catheter Ablation | FDA Approved Anti Arrhythmic Drug | Total | — |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | 2 Participants | 2 Participants | — |
| Age, Categorical Between 18 and 65 years | 2 Participants | 0 Participants | 2 Participants | — |
| Race and Ethnicity Not Collected | — | — | 0 Participants | — |
| Region of Enrollment United States | — | — | — | — participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | — |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 2 |
| other Total, other adverse events | 0 / 2 | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 |
Outcome results
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).
Time frame: 12 months
Population: 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.
Secondary
Change in Ejection Fraction (EF)
Change in Ejection Fraction heart failure measurement (percentage)
Time frame: baseline through15 months
Population: 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.
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
Time frame: 3 months through 15 months
Population: 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.
Secondary
Distance Walked in a 6-mile Walk Test
change in distance walked in 6 mile walk test
Time frame: 3 months through 15 months
Population: 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.
Secondary
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
Population: 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.
Secondary
Total Number of Cardiovascular Hospitalization
total number of cardiovascular hospitalization measured by hospitalization admissions
Time frame: 15 months
Population: 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.