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Premature Ventricular Contractions | Early Elimination of Premature Ventricular Contractions in Heart Failure

Premature Ventricular Contractions research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Premature Ventricular Contractions

Congestive Heart Failure

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:PVC ablationThis will compare symptoms, safety between ablation procedure vs medical therapy. Biosense Catheter used is not indicated specifically for PVC ablations and will be evaluated

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

ablation procedure vs medical therapyPVC ablation vs medical therapy

Compare 2 arms for safety, symptomsCompare control of PVC's between 2 groups.

Study Status

Terminated

Start Date: January 2013

Completed Date: May 17, 2017

Phase: N/A

Type: Interventional

Design:

Primary Outcome: change of left ventricular ejection fraction measured with Simpson's rule expressed in percent from pre to post intervention

Secondary Outcome: Change of echocardiographic Parameters

Study sponsors, principal investigator, and references

Principal Investigator: Timm Dickfeld, MD

Lead Sponsor: University of Maryland

Collaborator: Biosense Webster, Inc.

More information:https://clinicaltrials.gov/show/NCT01757067

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