Use of Adenosine to Determine the Electrophysiological Mechanism of Premature Ventricular Contractions
Primary Purpose
Premature Ventricular Contraction (PVC)
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Adenosine
Sponsored by
About this trial
This is an interventional diagnostic trial for Premature Ventricular Contraction (PVC) focused on measuring Subjects, diagnosed
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of premature ventricular contractions (PVCs)
- Scheduled to undergo an electrophysiology study with the intention of performing cardiac ablation for the treatment of PVCs
- Male or female between the ages of 18 and 70 years
- Capable of giving informed consent
Exclusion Criteria:
- Any structural heart disease
- Coronary artery disease (≥ 70% stenosis)
- Current treatment with anti-arrhythmic drugs
- Pregnant
- Asthma (if administering adenosine)
Sites / Locations
- Weill Cornell MedicineRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Adenosine/ Verapamil Arm
Arm Description
Adenosine: 0.84 mg/kg IV (140 mcg/kg/minute IV for 6 minutes) Verapamil: 0.15 mg/kg IV Adenosine is known to terminate ventricular arrhythmias that are due to triggered activity (ref Lerman). To study the effects of adenosine on PVC, the investigators will administer Verapamil to slow down the heart initially and adenosine after catheters are introduced to patients who are being treated for symptomatic PVC and have consented to treatment with an invasive electrophysiology study and catheter ablation.
Outcomes
Primary Outcome Measures
Effects of Adenosine on premature ventricular contractions (PVCs) as measured by EKG;
The metrics that will be collected will be:
Baseline frequency of premature ventricular contractions (PVCs)
Frequency of premature ventricular contractions (PVCs) during adenosine administration
Effects of verapamil on premature ventricular contractions (PVCs) as measured by EKGs.
The metrics that will be collected will be:
Baseline frequency of premature ventricular contractions (PVCs)
Frequency of premature ventricular contractions (PVCs) during verapamil administration
Secondary Outcome Measures
Full Information
NCT ID
NCT03218137
First Posted
June 29, 2017
Last Updated
September 25, 2023
Sponsor
Weill Medical College of Cornell University
1. Study Identification
Unique Protocol Identification Number
NCT03218137
Brief Title
Use of Adenosine to Determine the Electrophysiological Mechanism of Premature Ventricular Contractions
Official Title
Use of Adenosine to Determine the Electrophysiological Mechanism of Premature Ventricular Contractions
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 13, 2017 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Unblinded, controlled, non-randomized, mechanistic study to determine whether physiological mechanisms underlying PVC are sensitive to adenosine. One hundred subjects undergoing clinically-indicated, standard-of-care cardiac electrophysiology study (EPS) procedure for PVCs will receive adenosine and/or verapamil to learn if their arrhythmias are inducible similarly to sustained ventricular tachycardia.
Detailed Description
The cellular mechanism of premature ventricular contractions (PVCs) is unknown. The investigators have previously observed that 5% of patients in the investigators electrophysiology laboratory with ventricular outflow tract PVCs have inducible sustained ventricular tachycardia (VT) that behaves in a manner similar to patients who present clinically with sustained ventricular tachycardia, i.e., sensitive to adenosine and triggered activity. This suggests that outflow arrhythmias may be a continuum of a single mechanism.
Adenosine is known to terminate ventricular arrhythmias that are due to triggered activity (ref Lerman). To study the effects of adenosine on PVC, the investigators will administer Verapamil to slow down the heart initially and adenosine after catheters are introduced to patients who are being treated for symptomatic PVC and have consented to treatment with an invasive electrophysiology study and catheter ablation. The investigators will observe if there is any effect of reduced PVC following adenosine administration.
The investigators hypothesize that PVC will be suppressed by exogenous adenosine and/or verapamil. The information from this study will elucidate the underlying cellular mechanism of this common arrhythmia. Such knowledge could potentially lead to developing therapeutic targets. Moreover, it will have potential clinical applications for inducing outflow tract PVCs/VT in patients whose arrhythmia is suppressed at the time of their invasive electrophysiology study.
Analysis of the Holter recording of premature ventricular contractions:
Analysis of the PVC coupling intervals can be helpful for delineating the mechanism of PVCs. Holter monitors are being obtained on these patients prior to ablation as part of standard of care. Holters monitors, if performed at our institution, will be analyzed in detail in a retrospective fashion. Holter reports from 1/1/2015 - 5/15/2019 will be reviewed.
Specifically, evaluating the time intervals between PVCs and normal heart beats may elucidate potential arrhythmia mechanism as triggered activity or modulated parasystole. Since a subject has approximately 100,000 heart beats in 24 hours, the Holter data have to be read by a converter file and outputted to an Excel file for our further analysis. The investigators do not have access to a converter file and it is not commercially available. The investigators will send the de-identified data to Dr. Mortara at UCSF. The investigators will then analyze the timing intervals among PVCs and normal heart beats. It should be noted that these Holters are obtained as part of a patient's normal evaluation and are not obtained for the purposes of this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Ventricular Contraction (PVC)
Keywords
Subjects, diagnosed
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Adenosine/ Verapamil Arm
Arm Type
Other
Arm Description
Adenosine: 0.84 mg/kg IV (140 mcg/kg/minute IV for 6 minutes) Verapamil: 0.15 mg/kg IV
Adenosine is known to terminate ventricular arrhythmias that are due to triggered activity (ref Lerman). To study the effects of adenosine on PVC, the investigators will administer Verapamil to slow down the heart initially and adenosine after catheters are introduced to patients who are being treated for symptomatic PVC and have consented to treatment with an invasive electrophysiology study and catheter ablation.
Intervention Type
Drug
Intervention Name(s)
Adenosine
Other Intervention Name(s)
Verapamil 0.15 mg/kg
Intervention Description
Adenosine: 0.84 mg/kg (140 mcg/kg/minute IV for 6 minutes) Verapamil 0.15 mg/kg
Primary Outcome Measure Information:
Title
Effects of Adenosine on premature ventricular contractions (PVCs) as measured by EKG;
Description
The metrics that will be collected will be:
Baseline frequency of premature ventricular contractions (PVCs)
Frequency of premature ventricular contractions (PVCs) during adenosine administration
Time Frame
baseline
Title
Effects of verapamil on premature ventricular contractions (PVCs) as measured by EKGs.
Description
The metrics that will be collected will be:
Baseline frequency of premature ventricular contractions (PVCs)
Frequency of premature ventricular contractions (PVCs) during verapamil administration
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Diagnosis of premature ventricular contractions (PVCs)
Scheduled to undergo an electrophysiology study with the intention of performing cardiac ablation for the treatment of PVCs
Male or female between the ages of 18 and 70 years
Capable of giving informed consent
Exclusion Criteria:
Any structural heart disease
Coronary artery disease (≥ 70% stenosis)
Current treatment with anti-arrhythmic drugs
Pregnant
Asthma (if administering adenosine)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James E Ip, M.D
Phone
212 746 2158
Email
jei9008@med.cornell.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Dolores T Reynolds, BSN
Phone
212 746 4617
Email
dtr2001@med.cornell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James E Ip, M.D
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dolores T Reynolds, BSN
Phone
212-746-4617
Email
dtr2001@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
James E Ip, M.D
Phone
212 746 2158
Email
jei9008@med.cornell.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Use of Adenosine to Determine the Electrophysiological Mechanism of Premature Ventricular Contractions
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