Congestive Heart Failure, Premature Ventricular Contractions
Conditions
Keywords
ablations, CHF, PVC
Brief summary
Premature ventricular contractions (PVC) are a very common irregular heart beat (arrhythmias) even in patients without heart disease. Frequent PVCs are thought to occur in about 1-4% of the general population. Many patients with PVCs complain about skipping of their heart (palpitations), shortness of breath and feeling tired. In some patients PVCs may also result in weakening of the heart muscle (heart failure), which might be reversible with suppression of the PVCs.
Detailed description
A common way to get rid of PVCs is an ablation procedure during which a small area of heart muscle that creates the PVCs is cauterized, so that it can no longer cause PVCs. This has been performed for many years and is an overall safe and effective procedure to eliminate PVCs. In the ablation, a catheter with an electrode at its tip is guided with moving X-rays (fluoroscopy) displayed on a video screen to the exact site inside the heart where cells give off the electrical signals that stimulate the abnormal heart rhythm. Radiofrequency energy (similar to microwave heat) is transmitted from the catheter tip to the area. This destroys carefully selected heart muscle cells in a very small area (about 1/5 of an inch) and can stop the area from creating the extra impulses that cause the extra heartbeats. Additionally, some medications have the ability to suppress PVCs (antiarrhythmic medications). PVC ablation and antiarrhythmic medications have both been used to treat patients with PVC's and a reduced heart function. The heart function is referred to as ejection fraction (measured by cardiac ultrasound (echocardiogram). In this study it will be required the ejection fraction will be less than less than or equal to 45% (with 55% or more being normal). If enrolled in the study there is a 50/50 chance (like a coin toss and referred to as randomization) that the patient will either continue on the best currently available medical treatment for a weak heart muscle (as determined by the doctor) or will undergo a PVC catheter ablation (with a possible second ablation or antiarrhythmic medication, if the first ablation was not a success). All patients in the study will continue to take the best possible medications for the heart muscle weakness. If the patient is randomized to not undergo the ablation they will be monitored and at the end of 6 months of participation may choose to have the PVC ablation. If a deterioration may occur patients in the control group can have an ablation earlier.
Interventions
DEVICEPVC ablation
This will compare symptoms, safety between ablation procedure vs medical therapy. Biosense Catheter used is not indicated specifically for PVC ablations and will be evaluated
Sponsors
Biosense Webster, Inc.
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with reduced ejection fraction (EF ≤45%) demonstrated by transthoracic echocardiogram and deemed to be non-ischemic by nuclear stress test or cardiac catheterization. * Patients with \>20% PVCs on 24 hour holter-recording * Patient is 18 years of age or older * Optimized medical therapy on stable therapy for minimum 3 months with no changes in beta-blocker, ACE-I/ARB, digoxin doses (varying diuretic doses permitted).
Exclusion criteria
* Patients who are under the age of 18 years of age * Patients with \>2 dominant PVC morphologies * Patients with cardiac surgery in previous 3 months or scheduled for following 6 months * Patients who were implanted with a biventricular device during the last three months or single/dual chamber device (with ventricular pacing \>10%) during the last three months * Significant symptoms associated with PVCs that would make favor immediate ablation * Intracardiac mural thrombus or myxoma * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Left Ventricular Ejection Fraction Measured With Simpson's Rule Expressed in Percent From Pre to Post Intervention | Change between 0 and 6 months | Left ventricular ejection fraction with Simpson's Rule. This is a measurement obtained on an echocardiogram. It reflects the percentage of blood that is ejected from the heart with each beat. The mean change in ejection fraction will be compared for the 2 groups |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ablation Procedure Patient received PVC ablation in addition to optimal medical therapy | 2 |
| Medical Therapy Optimal medical therapy | 1 |
| Total | 3 |
Baseline characteristics
| Characteristic | Medical Therapy | Total | Ablation Procedure |
|---|---|---|---|
| Age, Continuous | 68 Years STANDARD_DEVIATION 0 | 67 Years STANDARD_DEVIATION 4 | 67 Years STANDARD_DEVIATION 3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Region of Enrollment Canada | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment China | 1 Participants | 1 Participants | 0 Participants |
| Region of Enrollment United States | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 1 |
| other Total, other adverse events | 0 / 2 | 0 / 1 |
| serious Total, serious adverse events | 0 / 2 | 0 / 1 |
Outcome results
Primary
Change of Left Ventricular Ejection Fraction Measured With Simpson's Rule Expressed in Percent From Pre to Post Intervention
Left ventricular ejection fraction with Simpson's Rule. This is a measurement obtained on an echocardiogram. It reflects the percentage of blood that is ejected from the heart with each beat. The mean change in ejection fraction will be compared for the 2 groups
Time frame: Change between 0 and 6 months
Population: Due to very low enrollment and closure of study no meaningful statistical analysis could be performed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ablation Procedure | Change of Left Ventricular Ejection Fraction Measured With Simpson's Rule Expressed in Percent From Pre to Post Intervention | 35 Percentage of EF | Standard Deviation 5 |
| Optimal Medical Therapy | Change of Left Ventricular Ejection Fraction Measured With Simpson's Rule Expressed in Percent From Pre to Post Intervention | 30 Percentage of EF | — |