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
Location: See all (8) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
United States
California
UCLA
Los Angeles
Massachusetts
Brigham and Women's Hospital
Boston
Maryland
University maryland medical Center
Baltimore
University of Maryland Medical Center
Baltimore
Michigan
University of Michigan
Ann Arbor
Ohio
Ohio State University
Columbus
Pennsylvania
University of Pennsylvania
Philadelphia
Other Locations
Canada
University of Quebec
Sainte-foy
Time Frame
Start Date: 2013-01
Completion Date: 2017-05-17
Participants
Target number of participants: 3
Treatments
Active_comparator: ablation procedure vs medical therapy
PVC ablation vs medical therapy
No_intervention: Compare 2 arms for safety, symptoms
Compare control of PVC's between 2 groups.
Sponsors
Collaborators: Biosense Webster, Inc.
Leads: University of Maryland, Baltimore

This content was sourced from clinicaltrials.gov