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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by University of Maryland.
Recruitment status was:  Not yet recruiting
Sponsor:
Collaborator:
Biosense Webster, Inc.
Information provided by (Responsible Party):
Timm-Michael Dickfeld, MD, University of Maryland
ClinicalTrials.gov Identifier:
NCT01757067
First received: December 3, 2012
Last updated: December 31, 2012
Last verified: December 2012
  Purpose

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.

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.


Condition Intervention Phase
Premature Ventricular Contractions
Congestive Heart Failure
Device: PVC ablation
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • change of left ventricular ejection fraction measured with Simpson's rule expressed in percent from pre to post intervention [ Time Frame: 0 and 6 months ] [ Designated as safety issue: Yes ]
    Ejection fraction by Echocardiography


Secondary Outcome Measures:
  • Change of echocardiographic Parameters [ Time Frame: 0 and 6 months ] [ Designated as safety issue: Yes ]
    Left Ventricular end-systolic volume index (LVESVI) Left Ventricular end-systolic dimension Left Ventricular end-diastolic volume Left Ventricular end-diastolic dimension

  • Change in serum biomarker level [ Time Frame: 0 and 6 months ] [ Designated as safety issue: Yes ]
    BNP, hs-Troponin, galectin-3

  • Change in Heart Failure Symptoms [ Time Frame: 0 and 6 months ] [ Designated as safety issue: Yes ]
    Assessed by heart failure questionnaire


Estimated Enrollment: 58
Study Start Date: January 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Surround Flow ablation catheters- Biosense Webster
No Intervention: Compare 2 arms for safety, symptoms
Compare control of PVC's between 2 groups.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01757067

Locations
United States, California
UCLA
Los Angeles, California, United States, 90095
United States, Illinois
Loyola University Health System
Maywood, Illinois, United States, 60153
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109-311
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210-1252
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Canada, Quebec
University of Quebec
Sainte-Foy, Quebec, Canada, G1V4G5
Sponsors and Collaborators
University of Maryland
Biosense Webster, Inc.
Investigators
Principal Investigator: Timm Dickfeld, MD University of Maryland
  More Information

Responsible Party: Timm-Michael Dickfeld, MD, Principal Investigator, University of Maryland
ClinicalTrials.gov Identifier: NCT01757067     History of Changes
Other Study ID Numbers: 53625 Evac-HF 
Study First Received: December 3, 2012
Last Updated: December 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Maryland:
ablations
CHF
PVC

Additional relevant MeSH terms:
Heart Failure
Premature Birth
Ventricular Premature Complexes
Heart Diseases
Cardiovascular Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Cardiac Complexes, Premature
Arrhythmias, Cardiac
Pathologic Processes

ClinicalTrials.gov processed this record on December 09, 2016