NCT01757067

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
2 countries

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2012

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 28, 2012

Completed
4 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2017

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

February 15, 2021

Completed
Last Updated

March 18, 2021

Status Verified

February 1, 2021

Enrollment Period

4.4 years

First QC Date

December 3, 2012

Results QC Date

May 15, 2020

Last Update Submit

February 25, 2021

Conditions

Premature Ventricular ContractionsCongestive Heart Failure

Keywords

ablationsCHFPVC

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

ablation procedure vs medical therapy

ACTIVE COMPARATOR

PVC ablation vs medical therapy

Device: PVC ablation

Compare 2 arms for safety, symptoms

NO INTERVENTION

Compare control of PVC's between 2 groups.

Interventions

PVC ablationDEVICE

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

Also known as: Surround Flow ablation catheters- Biosense Webster
ablation procedure vs medical therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

UCLA

Los Angeles, California, 90095, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

University maryland medical Center

Baltimore, Maryland, 21229, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109-311, United States

Location

Ohio State University

Columbus, Ohio, 43210-1252, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Quebec

Sainte-Foy, Quebec, G1V4G5, Canada

Location

MeSH Terms

Conditions

Ventricular Premature ComplexesHeart Failure

Condition Hierarchy (Ancestors)

Cardiac Complexes, PrematureArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Timm-Michael Dickfeld
Organization
University of Maryland Medical Center
Tdickfel@som.umaryland.edu
410-328-7801

Study Officials

  • Timm Dickfeld, MD

    University of Maryland, College Park

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 3, 2012

First Posted

December 28, 2012

Study Start

January 1, 2013

Primary Completion

May 17, 2017

Study Completion

May 17, 2017

Last Updated

March 18, 2021

Results First Posted

February 15, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(7)CA(1)