Ignite Creation Date:
2024-05-06 @ 1:13 AM
Last Modification Date:
2024-10-26 @ 11:01 AM
Study NCT ID:
NCT01757067
Status:
TERMINATED
Last Update Posted:
2021-03-18
First Post:
2012-12-03
Brief Title:
Early Elimination of Premature Ventricular Contractions in Heart Failure
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
EVAC-HF is a Prospective Multi-center Randomized Study to Compare the Effects on LV Systolic Function Following Radiofrequency Catheter Ablation of Frequent Premature Ventricular Contraction With Optimized Medical Therapy Alone
Status:
TERMINATED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to recruit sufficient participants
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EVAC-HF
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 15 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 PVCs 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 5050 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
If enrolled in the study there is a 5050 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None