Status:
UNKNOWN
Prospective Assessment of Premature Ventricular Contractions Suppression in Cardiomyopathy(PAPS)
Lead Sponsor:
Hunter Holmes Mcguire Veteran Affairs Medical Center
Collaborating Sponsors:
Virginia Commonwealth University
University of California, San Francisco
Conditions:
Ventricular Premature Beats, Contractions, or Systoles
Cardiomyopathies
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Premature ventricular contractions (PVCs) coexist in patients with heart failure (HF) and LV dysfunction. Frequent PVCs have shown to induce a reversible cardiomyopathy (PVC-CM). This clinical pilot ...
Detailed Description
Rationale. Frequent PVCs have shown to induce a reversible cardiomyopathy (PVC-CM). Yet, it is unclear why some patients develop PVC-CM, while others do not. Appropriate diagnosis and treatment of pat...
Eligibility Criteria
Inclusion
- LV dysfunction (calculated LVEF \< or equal to45% based on Echo) within 150 days of Enrollment (Day 0)
- PVC burden \> or equal to 10% by at least a 24-hr ambulatory Holter monitor (within 150 days of Enrollment (Day 0)
Exclusion
- Age \< 18 years old
- Current amiodarone use or within last 2 months
- Current use of antiarrhythmic drugs class I or III
- Contraindication to amiodarone use or any other class III antiarrhythmic
- Severely symptomatic PVCs (unable to complete 3-month observation period)
- Severe/significant CAD with planned revascularization in the near future
- Complete AV block and pacemaker dependent
- Pacemaker or ICD with \>10% RV pacing
- Severe valvular heart disease or planned valvular/cardiac surgery
- Uncontrolled / untreated endocrinopathies
- Uncontrolled HTN, (systolic BP \>180mmHg or diastolic \>110 mmHg)
- Hypertrophic cardiomyopathy
- Systemic infiltrative and immune disorders
- Family history of dilated CM in a first degree relative
- Alcohol abuse or illicit drug use
- Contraindication to short-term acute anticoagulation (due to possible randomization to ablation)
- Atrial fibrillation and flutter with rapid ventricular response with possible tachycardia-induced cardiomyopathy
- Possible infectious etiology of cardiomyopathy
- Pregnant or lactating women
- Previous PVC ablation
Key Trial Info
Start Date :
August 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2021
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03228823
Start Date
August 1 2018
End Date
August 31 2021
Last Update
April 14 2021
Active Locations (11)
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1
University of California Los Angeles Medical Center
Los Angeles, California, United States, 90095
2
University of California, San Francisco
San Francisco, California, United States, 94143
3
James A. Haley Veterans' Hospital
Tampa, Florida, United States, 33612
4
Rush University Medical Center
Chicago, Illinois, United States, 60612