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

NCT03218137 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 1609017561
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Ventricular Contraction (PVC)

Keywords

Subjects; diagnosed

Outcome Measures

Primary Outcomes (2)

• 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

  baseline

• 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

  baseline

Study Arms (1)

Adenosine/ Verapamil Arm

OTHER

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

Adenosine DRUG

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

Adenosine/ Verapamil Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

RECRUITING

MeSH Terms

Conditions

Ventricular Premature Complexes; Disease

Interventions

Adenosine; Verapamil

Condition Hierarchy (Ancestors)

Cardiac Complexes, Premature; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• James E Ip, M.D

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James E Ip, M.D

CONTACT

212 746 2158; jei9008@med.cornell.edu

Dolores T Reynolds, BSN

CONTACT

212 746 4617; dtr2001@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2017
• First Posted: July 14, 2017
• Study Start: February 13, 2017
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)