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Unable to recruit sufficient participants
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| Name | Class |
|---|---|
| Biosense Webster, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ablation procedure vs medical therapy | Active Comparator | PVC ablation vs medical therapy |
|
| Compare 2 arms for safety, symptoms | No Intervention | Compare control of PVC's between 2 groups. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PVC ablation | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timm Dickfeld, MD | University of Maryland, College Park | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA | Los Angeles | California | 90095 | United States | ||
| University of Maryland Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | PVC Ablation Plus Optimal Medical Therapy | 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. |
| FG001 | Optimal Medical Therapy | Patients will receive optimal medical therapy including beta blocker or afterload reduction with e.g. ACE-inhibitors as directed by treating local cardiologist/electrophysiologist. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The site enrolled 3 participants in the study
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| ID | Title | Description |
|---|---|---|
| BG000 | Ablation Procedure | Patient received PVC ablation in addition to optimal medical therapy |
| BG001 | Medical Therapy | Optimal medical therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Due to very low enrollment and closure of study no meaningful statistical analysis could be performed | Posted | Mean | Standard Deviation | Percentage of EF | Change between 0 and 6 months |
|
0 to 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ablation Procedure and Optimal Medical Therapy | In the group that received PVC ablation and optimal medical therapy no AE occured. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Timm-Michael Dickfeld | University of Maryland Medical Center | 410-328-7801 | Tdickfel@som.umaryland.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 17, 2011 | Aug 30, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 17, 2011 | Aug 30, 2020 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 5, 2015 | Jan 6, 2021 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D018879 | Ventricular Premature Complexes |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D005117 | Cardiac Complexes, Premature |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| Baltimore |
| Maryland |
| 21201 |
| United States |
| University maryland medical Center | Baltimore | Maryland | 21229 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109-311 | United States |
| Ohio State University | Columbus | Ohio | 43210-1252 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University of Quebec | Sainte-Foy | Quebec | G1V4G5 | Canada |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
group received only optimal medical therapy |
|
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Optimal Medical Therapy | In the group that received optimal medical therapy no AE occured | 0 | 1 | 0 | 1 | 0 | 1 |
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| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |