Clinical trial NCT01757067: Early Elimination of Premature Ventricular Contractions in Heart Failure
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Premature Ventricular Contractions
Congestive Heart Failure
Keywords: ablations
CHF
PVC
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: Biosense Webster, Inc.
First posted: 2012-12-28
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of Left Ventricular Ejection Fraction Measured With Simpson's Rule Expressed in Percent From Pre to Post Intervention
timeFrame: Change between 0 and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Baltimore
country: United States
facility: University maryland medical Center
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Sainte-Foy
country: Canada
facility: University of Quebec
state: Quebec
Study officials:
affiliation: University of Maryland, College Park
name: Timm Dickfeld, MD
role: PRINCIPAL_INVESTIGATOR
References: