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

• Sponsor: University of Maryland, Baltimore (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01757067
• Collaborator: Biosense Webster, Inc. (Industry)
• Enrollment: 3
• Locations: 8
• Arms: 2
• Duration (Months): 52.5
• Patients Per Site: 0.4
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Premature Ventricular Contractions; Congestive Heart Failure	Device: PVC ablation	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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.
• Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: May 17, 2017
• Actual Study Completion Date: May 17, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change of Left Ventricular Ejection Fraction Measured With Simpson's Rule Expressed in Percent From Pre to Post Intervention [Change between 0 and 6 months]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	UCLA	Los Angeles	California	United States	90095
2	University of Maryland Medical Center	Baltimore	Maryland	United States	21201
3	University maryland medical Center	Baltimore	Maryland	United States	21229
4	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
5	University of Michigan	Ann Arbor	Michigan	United States	48109-311
6	Ohio State University	Columbus	Ohio	United States	43210-1252
7	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
8	University of Quebec	Sainte-Foy	Quebec	Canada	G1V4G5

Sponsors and Collaborators

• University of Maryland, Baltimore
• Biosense Webster, Inc.

Investigators

• Principal Investigator: Timm Dickfeld, MD, University of Maryland, College Park

Study Documents (Full-Text)

• Study Protocol - Sep 17, 2011
• Statistical Analysis Plan - Sep 17, 2011
• Informed Consent Form - Oct 5, 2015

More Information

Publications

None provided.

• Responsible Party: Timm-Michael Dickfeld, Principal Investigator, University of Maryland, Baltimore
• ClinicalTrials.gov Identifier: NCT01757067
• Other Study ID Numbers: HP-00053625
• First Posted: Dec 28, 2012
• Last Update Posted: Mar 18, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Timm-Michael Dickfeld, Principal Investigator, University of Maryland, Baltimore: ablations; CHF; PVC
• Additional relevant MeSH terms: Premature Birth; Heart Failure; Ventricular Premature Complexes

Study Results

Participant Flow

Arm/Group Title	PVC Ablation Plus Optimal Medical Therapy	Optimal Medical Therapy
Arm/Group Description	Patients will receive optimal medical therapy including beta blocker or afterload reduction with e.g. ACE-inhibitors as directed by treating local cardiologist/electrophysiologist. In addition patient will undergo radiofrequency ablation of PVC guided by current gold standard of ablation including pace mapping and activation mapping to reduce the PVC burden.	Patients will receive optimal medical therapy including beta blocker or afterload reduction with e.g. ACE-inhibitors as directed by treating local cardiologist/electrophysiologist.
Period Title: Overall Study
STARTED	2	1
COMPLETED	2	1
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Ablation Procedure	Medical Therapy	Total
Arm/Group Description	Patient received PVC ablation in addition to optimal medical therapy	Optimal medical therapy	Total of all reporting groups
Overall Participants	2	1	3
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	67 (3)	68 (0)	67 (4)
Sex: Female, Male (Count of Participants)
Female	1 50%	1 100%	2 66.7%
Male	1 50%	0 0%	1 33.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	0 0%	0 0%	0 0%
Unknown or Not Reported	2 100%	1 100%	3 100%
Region of Enrollment (Count of Participants)
United States	1 50%	0 0%	1 33.3%
Canada	1 50%	0 0%	1 33.3%
China	0 0%	1 100%	1 33.3%

Outcome Measures

1. Primary Outcome

Title	Change of Left Ventricular Ejection Fraction Measured With Simpson's Rule Expressed in Percent From Pre to Post Intervention
Description	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
Time Frame	Change between 0 and 6 months

Outcome Measure Data

Analysis Population Description

Due to very low enrollment and closure of study no meaningful statistical analysis could be performed

Arm/Group Title	Ablation Procedure	Optimal Medical Therapy
Arm/Group Description	PVC ablation will be performed in these patients in addition to optimal medical therapy.	group received only optimal medical therapy
Measure Participants	2	1
Mean (Standard Deviation) [Percentage of EF]	35 (5)	30

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ablation Procedure, Optimal Medical Therapy
	Comments
	Type of Statistical Test	Other
	Comments	The previously stated primary and secondary endpoints cannot be calculated as the study was halted prematurely due to lack of enrollment. Only the reported EF data was collected. This makes further statistical analyses impossible.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Other Statistical Analysis		The previously stated primary and secondary endpoints cannot be calculated as the study was halted prematurely due to lack of enrollment. Only the reported EF data was collected. This makes further statistical analyses impossible.

Adverse Events

Time Frame	0 to 6 months
Arm/Group Title	Ablation Procedure and Optimal Medical Therapy		Optimal Medical Therapy
Arm/Group Description	In the group that received PVC ablation and optimal medical therapy no AE occured.		In the group that received optimal medical therapy no AE occured
All Cause Mortality
	Ablation Procedure and Optimal Medical Therapy		Optimal Medical Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/1 (0%)
Serious Adverse Events
	Ablation Procedure and Optimal Medical Therapy		Optimal Medical Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/1 (0%)
Other (Not Including Serious) Adverse Events
	Ablation Procedure and Optimal Medical Therapy		Optimal Medical Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/1 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.