Early Elimination of Premature Ventricular Contractions in Heart Failure (EVAC-HF)

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.

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.

Study Overview

• Status: Terminated
• Conditions: Congestive Heart Failure; Premature Ventricular Contractions
• Intervention / Treatment: Device: PVC ablation

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sainte-Foy, Quebec, Canada, G1V4G5
      • University of Quebec
• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center
    • Baltimore, Maryland, United States, 21229
      • University maryland medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-311
      • University of Michigan
  • Ohio
    • Columbus, Ohio, United States, 43210-1252
      • Ohio State University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ablation procedure vs medical therapy; PVC ablation vs medical therapy	Device: PVC 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; Other Names: Surround Flow ablation catheters- Biosense Webster
No Intervention: Compare 2 arms for safety, symptoms; Compare control of PVC's between 2 groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Change between 0 and 6 months

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Collaborators: Biosense Webster, Inc.
• Investigators: Principal Investigator: Timm Dickfeld, MD, University of Maryland, College Park

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): May 17, 2017
• Study Completion (Actual): May 17, 2017

Study Registration Dates

• First Submitted: December 3, 2012
• First Submitted That Met QC Criteria: December 20, 2012
• First Posted (Estimate): December 28, 2012

Study Record Updates

• Last Update Posted (Actual): March 18, 2021
• Last Update Submitted That Met QC Criteria: February 25, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: CHF; ablations; PVC
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Cardiac Complexes, Premature; Heart Failure; Premature Birth; Ventricular Premature Complexes
• Other Study ID Numbers: HP-00053625

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No