Premature Ventricular Contraction (PVC)Phase 4NCT03218137
Use of Adenosine to Determine the Electrophysiological Mechanism of Premature Ventricular Contractions
A Phase 4 study testing Adenosine in people with Premature Ventricular Contraction (PVC), run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Premature Ventricular Contraction (PVC)
- What is being tested?
- Adenosine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2017to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Any structural heart disease
- Coronary artery disease (≥ 70% stenosis)
- Current treatment with anti-arrhythmic drugs
- Pregnant
- Asthma (if administering adenosine)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Weill Cornell Medicine
New York, New York, 10065
Dolores T Reynolds, BSN, 212 746 4617, dtr2001@med.cornell.edu
James E Ip, M.D, 212 746 2158, jei9008@med.cornell.edu
About this study
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.
- Conditions
- Premature Ventricular Contraction (PVC)
- Being tested
- Adenosine
- Keywords
- Subjects, diagnosed
- Medical subject headings
- Ventricular Premature Complexes, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdenosineDrug
Also called Verapamil 0.15 mg/kg
Adenosine: 0.84 mg/kg (140 mcg/kg/minute IV for 6 minutes) Verapamil 0.15 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Adenosine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start13 Feb 2017
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ventricular Contraction (PVC)Studies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James E Ip, M.D, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218137
- Sponsor's protocol ID
- 1609017561
- Status last verified
- Jun 2026
- First submitted
- 29 Jun 2017
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Adenosine to Determine the Electrophysiological Mechanism of Premature Ventricular Contractions
- ClinicalTrials.gov ID
- NCT03218137
- Acronym / sponsor ID
- 1609017561
- Conditions
- Premature Ventricular Contraction (PVC)
- Keywords
- Subjects, diagnosed
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adenosine/ Verapamil Arm | Other | Drug: AdenosineAdenosine: 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Any structural heart disease
- Coronary artery disease (≥ 70% stenosis)
- Current treatment with anti-arrhythmic drugs
- Pregnant
- Asthma (if administering adenosine)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdenosineAlso: Verapamil 0.15 mg/kgAdenosine: 0.84 mg/kg (140 mcg/kg/minute IV for 6 minutes) Verapamil 0.15 mg/kg | Drug | Adenosine/ Verapamil Arm |
Primary outcome
Effects of Adenosine on premature ventricular contractions (PVCs) as measured by EKG;
Time frame: baseline
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.
Time frame: baseline
The metrics that will be collected will be: * Baseline frequency of premature ventricular contractions (PVCs) * Frequency of premature ventricular contractions (PVCs) during verapamil administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Premature Ventricular Contraction (PVC)
RecruitingObservational study
Physical Impairments in Premature Ventricular Complex
Premature Ventricular Complexes
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
RecruitingObservational study
AI-Based Differential Diagnosis and Localization of Tachycardia Using ECG: Multicenter Registry (EP-AI ASSIST)
Tachycardia, Paroxysmal Supraventricular Tachycardia
Not yet recruitingObservational study
Premature Ventricular Complex and Diet Inflamatuar Index
Premature Ventricular Complexes, Diet Quality
Recruiting
Disrupted Sleep and Concurrent Ectopy or Atrial Fibrillation
Obstructive Sleep Apnea, Premature Ventricular Contraction (PVC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James E Ip, M.D principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adenosine in people with Premature Ventricular Contraction (PVC), run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James E Ip, M.D (212 746 2158, jei9008@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of Adenosine on premature ventricular contractions (PVCs) as measured by EKG; (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.