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RecruitingNCT03218137Updated Jun 23, 2026

Use of Adenosine to Determine the Electrophysiological Mechanism of Premature Ventricular Contractions

A Phase 4 interventional study of Adenosine in Premature Ventricular Contraction (PVC), sponsored by Weill Medical College of Cornell University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-23.

Sponsored by Weill Medical College of Cornell University · Phase 4, Interventional, and Diagnostic

Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Premature Ventricular Contraction (PVC)

Keywords

  • Subjects
  • diagnosed
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Any structural heart disease
  • Coronary artery disease (≥ 70% stenosis)
  • Current treatment with anti-arrhythmic drugs
  • Pregnant
  • Asthma (if administering adenosine)
04

Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Other
    Adenosine/ Verapamil Arm

    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.

    Drug: Adenosine

Interventions

  • DrugAdenosine

    Adenosine: 0.84 mg/kg (140 mcg/kg/minute IV for 6 minutes) Verapamil 0.15 mg/kg

    Also known as: Verapamil 0.15 mg/kg

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: baseline

  2. 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

    Time frame: baseline

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03218137
Lead sponsor
Weill Medical College of Cornell University
Responsible party
Sponsor
First posted
Jul 14, 2017
Start date
Feb 13, 2017
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Jun 23, 2026

Study contacts

James E Ip, M.D
Contact
jei9008@med.cornell.edu
212 746 2158
Dolores T Reynolds, BSN
Contact
dtr2001@med.cornell.edu
212 746 4617
James E Ip, M.D
principal investigator · Weill Medical College of Cornell University

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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