Ventricular Premature Beats, Contractions, or SystolesPhase 4PAPSNCT03228823
Prospective Assessment of Premature Ventricular Contractions Suppression in Cardiomyopathy(PAPS)
A Phase 4 study testing Radiofrequency ablation and Amiodarone (Antiarrhythmic drug) in people with Ventricular Premature Beats, Contractions, or Systoles and Cardiomyopathies, run by Hunter Holmes Mcguire Veteran Affairs Medical Center at 11 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Premature Beats, Contractions, or Systoles, Cardiomyopathies
- What is being tested?
- Radiofrequency ablation and Amiodarone (Antiarrhythmic drug)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 1 Aug 2018to 31 Aug 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States10 sites
University of Virginia
Charlottesville, Virginia, 22908
Rush University Medical Center
Chicago, Illinois, 60612
University of California Los Angeles Medical Center
Los Angeles, California, 90095
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104
McGuire VA Medical Center
Richmond, Virginia, 23249
Virginia Commonwealth University
Richmond, Virginia, 23298
University of California, San Francisco
San Francisco, California, 94143
Northwell Health System-Staten Island University Hospital
Staten Island, New York, 10305
James A. Haley Veterans' Hospital
Tampa, Florida, 33612
Roxbury VA Medical Center
West Roxbury, Massachusetts, 02132
Canada1 site
Libin Cardiovascular Institute, University of Calgary
Calgary, Alberta, T2N 2T9
About this study
Official title: Prospective Assessment of Premature Ventricular Contractions Suppression in Cardiomyopathy(PAPS): A Pilot Study
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 study will enroll 36 patients with frequent PVCs (burden >10%) and CM (LVEF <45%) and randomize them to either: 1) RFA or 2) AADs. Prior to treatment, patients will undergo a baseline cardiac MR if clinically indicated followed by 3-month observation period (optimal HF medical therapy). Changes in LV function/scar, PVC burden/arrhythmias and clinical/functional status (QOL, HF symptoms and admissions, NYHA class) and adverse events will be assessed throughout the observation period and compare with PVC suppression strategies (RFA or AAD). Similar comparison will be made between RFA and AAD treatment groups during a 12-month follow up using a Prospective Randomized Open, Blinded End-point (PROBE) study design. The treatment regimens will be compared in an intention-to-treat analysis. In addition, a total of 20,000 consecutive ambulatory ECG Holter monitors from all participating centers will be screened to identify all patients with probable diagnosis of PVC-CM.
This pilot study is intended to estimate the prevalence of this clinical entity and pave the way for a large full scale randomized trial to identify best treatment strategy for patients with PVC-CM. Treating and reversing this underestimated PVC-CM may improve patient's health and subsequently decrease HF healthcare spending.
Read the 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 patients with PVC-CM is believed to carry significant benefits, improving quality of life (QOL), HF symptoms / admissions and life expectancy. Currently, these patients are offered radiofrequency ablation (RFA), antiarrhythmic drugs (AADs) or no treatment depending on physician's experience and resources. Nevertheless, no randomized-prospective study exists to support the benefit of RFA. Thus, a large-scale multicenter randomized clinical trial entitled "Prospective Assessment of PVC Suppression in Cardiomyopathy (PAPS)"' study has been planned to compare these treatment strategies. However, a PAPS pilot study is proposed to better estimate the potential affected patient population, limitations of enrollment, rate of clinical outcomes, potential crossover and drop out. This pilot study is key to better design and power the large-scale multicenter PAPS trial.
Objective. PAPS pilot study is a randomized clinical trial to assess the feasibility of enrolling, randomizing treatment strategies and retaining participants with frequent PVCs and associated CM.
Hypotheses. Our main hypotheses of the PAPS pilot study are:
- A large-scale randomized PAPS clinical study is feasible with minimal barriers of enrollment, treatment crossover and drop out due to a unique design including a short observation period and PVC suppression strategy in all participants.
- The rate of responders (defined as improvement of LVEF ≥ 10% points) with HF medical therapy alone during observation period will be less than 15%. In contrast, RFA and AADs will have a responder rate of at least 35% in the same population. Furthermore, RFA will have a greater 1-year response rate when compared to AAD therapy.
- RFA will have a lower rate of composite adverse events (worsening NYHA class, HF admission, treatment side effects \& complications, and death), arrhythmia burden and a better long-term tolerance than AADs.
Methods. A prospective clinical pilot study is planned to prove the feasibility of a large-scale multicenter clinical trial (PAPS study) of patients with probable PVC-CM. This pilot study will enroll 36 patients with frequent PVCs (burden ≥10%) and CM (LVEF ≤45%) and randomize them to either: 1) RFA or 2) AADs. Prior to treatment, all patients will undergo a baseline cardiac MR if clinically indicated and be allowed a 3-month observation period (optimal HF medical therapy). To assess the effects of PVC suppression, changes in LV function, rate of responders (defined above), PVC burden/arrhythmias and clinical/functional status (QOL, HF symptoms and admissions, NYHA class) and adverse events will be compared between observation period and both PVC suppression strategies (RFA or AAD). To identify the best PVC suppression strategy, similar comparisons between RFA and AAD treatment groups will be performed at 12-month follow up using a Prospective Randomized Open, Blinded End-point (PROBE) study design. The treatment regimens will be compared in an intention-to-treat analysis.
In summary, the multicenter PAPS pilot study is intended to better estimate the prevalence of PVC-CM, prove feasibility and rates of clinical outcomes. This pilot study with a multidisciplinary approach will pave the way for a large-scale randomized PAPS trial to identify the best treatment strategy for patients with PVC-CM. Treating and reversing PVC-CM with its associated HF morbidity and mortality will impact not only healthcare spending, but most importantly it will improve patient's health, quality of life and long-term prognosis.
- Being tested
- Radiofrequency ablation, Amiodarone (Antiarrhythmic drug)
- Keywords
- Premature Ventricular contractions, Cardiomyopathy
- Medical subject headings
- Ventricular Premature Complexes, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablationProcedure or surgery
Also called Ablation
RFA to achieve PVC suppression will be performed using standard techniques and protocols similar to those patients that do not participate in this clinical study.
Amiodarone (Antiarrhythmic drug)Drug
Also called Amiodarone
AAD therapy of choice is amiodarone. Amiodarone loading dose of 10 grams is recommended, followed by maintenance dose of 200-400mg daily to achieve successful PVC suppression. Alternatively, sotalol and/or propafenone could be considered at discretion of electrophysiologists (sotalol dose of at least 120mg twice daily, propafenone 150-300mg tid) if there is a significant concern of safety profile of amiodarone.
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency Ablation | Active comparator | Radiofrequency ablation (RFA) will be performed after 3-month observation period. EPS and RFA will be performed using standard techniques and protocols similar to those patients that do not participate in this clinical study. In the event of polymorphic PVCs, all morphologies are to be targeted for ablation Receives: Procedure: Radiofrequency ablation |
| Antiarrhythmic Drug | Active comparator | Antiarrhythmic drugs (AADs) will be only initiated after 3-month observation period. AAD therapy of choice is amiodarone. Amiodarone loading dose of 10 grams is recommended, followed by maintenance dose of 200-400mg daily to achieve successful PVC suppression. Investigators define successful PVC suppression only if ≥ 80% absolute reduction in PVC burden is achieved after a drug or intervention. Alternatively, sotalol and/or propafenone could be considered at discretion of electrophysiologists (sotalol dose of at least 120mg twice daily, propafenone 150-300mg tid) if there is a significant concern of safety profile of amiodarone. Receives: Drug: Amiodarone (Antiarrhythmic drug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of left ventricular ejection fraction after PVC suppression
Compare the overall improvement or change in LVEF between RFA and AAD groups.
Measured: 12 months
Responders to PVC suppression strategy
Assessment of the number of responders (delta LVEF ≥ 10%) after PVC suppression strategies will assess the effectiveness of RFA and AADs to reverse or improve cardiomyopathy induced by frequent PVCs.
Measured: 12 months
Secondary outcomes (3)
Successful PVC suppression
Efficacy of Radiofrequency ablation vs. Antiarrhythmic drugs to achieve successful PVC suppression (defined as a reduction of PVC burden greater than ≥80%).
Measured: 12 months
Composite Adverse Events
Composite end-point of adverse events, including worsening in NYHA functional class (I-IV), number of HF and cardiac-related admissions, RFA complications and AAD adverse effects and cardiovascular death.
Measured: 12 months
Composite Arrhythmia Burden
Composite end-point of arrhythmia burden, including PVC recurrence, non-sustained (< 30sec) and sustained (> 30sec) ventricular arrhythmias and arrhythmic sudden cardiac death
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start1 Aug 2018
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventricular Premature Beats, Contractions, or SystolesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- PVC suppression with either antiarrhythmic drugs or radiofrequency ablation
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Virginia Commonwealth University, University of California, San Francisco, University of Calgary, Washington University School of Medicine, Wake Forest University Health Sciences, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jose Huizar, Hunter Holmes Mcguire Veteran Affairs Medical Center
- Investigators
- Jose F Huizar, M.D., Study director, McGuire VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03228823
- Sponsor's protocol ID
- NIH ID 9372611
- Other IDs
- R34HL138110-01
- Acronym
- PAPS
- Status last verified
- Apr 2021
- First submitted
- 18 Jul 2017
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: This is solely a pilot study of frequent PVCs and cardiomyopathy. Results of this preliminary data will not provide final definitive data, yet investigators will make it available. However, investigators will make clear that this pilot data is not intended to answer benefits of different PVC suppression strategies to avoid misinterpretation or inaccurate conclusions based solely on preliminary data.
Publications
Torrado J, Sima A, Comstuck C, Kaszala K, Tan A, Koneru J, Frankel DS, Marchlinski F, Kowalski M, Sharma P, Gerstenfeld EP, Vaseghi M, Shivkumar K, Malhotra R, Morillo C, Ellenbogen KA, Huizar JF. Prevalence of frequent premature ventricular contractions and left-ventricular systolic dysfunction in patients receiving Holter monitoring. J Cardiovasc Electrophysiol. 2025 Jan;36(1):54-61. doi: 10.1111/jce.16478. Epub 2024 Oct 24.
PubMed 39445764
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Assessment of Premature Ventricular Contractions Suppression in Cardiomyopathy(PAPS): A Pilot Study
- ClinicalTrials.gov ID
- NCT03228823
- Acronym / sponsor ID
- PAPS / NIH ID 9372611
- Keywords
- Premature Ventricular contractions, Cardiomyopathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical CenterUS federal agency
- Collaborators
- Virginia Commonwealth University, University of California, San Francisco, University of Calgary, Washington University School of Medicine, Wake Forest University Health Sciences, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 25 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.
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 study will enroll 36 patients with frequent PVCs (burden >10%) and CM (LVEF <45%) and randomize them to either: 1) RFA or 2) AADs. Prior to treatment, patients will undergo a baseline cardiac MR if clinically indicated followed by 3-month observation period (optimal HF medical therapy). Changes in LV function/scar, PVC burden/arrhythmias and clinical/functional status (QOL, HF symptoms and admissions, NYHA class) and adverse events will be assessed throughout the observation period and compare with PVC suppression strategies (RFA or AAD). Similar comparison will be made between RFA and AAD treatment groups during a 12-month follow up using a Prospective Randomized Open, Blinded End-point (PROBE) study design. The treatment regimens will be compared in an intention-to-treat analysis. In addition, a total of 20,000 consecutive ambulatory ECG Holter monitors from all participating centers will be screened to identify all patients with probable diagnosis of PVC-CM.
This pilot study is intended to estimate the prevalence of this clinical entity and pave the way for a large full scale randomized trial to identify best treatment strategy for patients with PVC-CM. Treating and reversing this underestimated PVC-CM may improve patient's health and subsequently decrease HF healthcare spending.
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 patients with PVC-CM is believed to carry significant benefits, improving quality of life (QOL), HF symptoms / admissions and life expectancy. Currently, these patients are offered radiofrequency ablation (RFA), antiarrhythmic drugs (AADs) or no treatment depending on physician's experience and resources. Nevertheless, no randomized-prospective study exists to support the benefit of RFA. Thus, a large-scale multicenter randomized clinical trial entitled "Prospective Assessment of PVC Suppression in Cardiomyopathy (PAPS)"' study has been planned to compare these treatment strategies. However, a PAPS pilot study is proposed to better estimate the potential affected patient population, limitations of enrollment, rate of clinical outcomes, potential crossover and drop out. This pilot study is key to better design and power the large-scale multicenter PAPS trial.
Objective. PAPS pilot study is a randomized clinical trial to assess the feasibility of enrolling, randomizing treatment strategies and retaining participants with frequent PVCs and associated CM.
Hypotheses. Our main hypotheses of the PAPS pilot study are:
- A large-scale randomized PAPS clinical study is feasible with minimal barriers of enrollment, treatment crossover and drop out due to a unique design including a short observation period and PVC suppression strategy in all participants.
- The rate of responders (defined as improvement of LVEF ≥ 10% points) with HF medical therapy alone during observation period will be less than 15%. In contrast, RFA and AADs will have a responder rate of at least 35% in the same population. Furthermore, RFA will have a greater 1-year response rate when compared to AAD therapy.
- RFA will have a lower rate of composite adverse events (worsening NYHA class, HF admission, treatment side effects \& complications, and death), arrhythmia burden and a better long-term tolerance than AADs.
Methods. A prospective clinical pilot study is planned to prove the feasibility of a large-scale multicenter clinical trial (PAPS study) of patients with probable PVC-CM. This pilot study will enroll 36 patients with frequent PVCs (burden ≥10%) and CM (LVEF ≤45%) and randomize them to either: 1) RFA or 2) AADs. Prior to treatment, all patients will undergo a baseline cardiac MR if clinically indicated and be allowed a 3-month observation period (optimal HF medical therapy). To assess the effects of PVC suppression, changes in LV function, rate of responders (defined above), PVC burden/arrhythmias and clinical/functional status (QOL, HF symptoms and admissions, NYHA class) and adverse events will be compared between observation period and both PVC suppression strategies (RFA or AAD). To identify the best PVC suppression strategy, similar comparisons between RFA and AAD treatment groups will be performed at 12-month follow up using a Prospective Randomized Open, Blinded End-point (PROBE) study design. The treatment regimens will be compared in an intention-to-treat analysis.
In summary, the multicenter PAPS pilot study is intended to better estimate the prevalence of PVC-CM, prove feasibility and rates of clinical outcomes. This pilot study with a multidisciplinary approach will pave the way for a large-scale randomized PAPS trial to identify the best treatment strategy for patients with PVC-CM. Treating and reversing PVC-CM with its associated HF morbidity and mortality will impact not only healthcare spending, but most importantly it will improve patient's health, quality of life and long-term prognosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- PVC suppression with either antiarrhythmic drugs or radiofrequency ablation
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency Ablation | Active comparator | Procedure: Radiofrequency ablationRadiofrequency ablation (RFA) will be performed after 3-month observation period. EPS and RFA will be performed using standard techniques and protocols similar to those patients that do not participate in this clinical study. In the event of polymorphic PVCs, all morphologies are to be targeted for ablation |
| Antiarrhythmic Drug | Active comparator | Drug: Amiodarone (Antiarrhythmic drug)Antiarrhythmic drugs (AADs) will be only initiated after 3-month observation period. AAD therapy of choice is amiodarone. Amiodarone loading dose of 10 grams is recommended, followed by maintenance dose of 200-400mg daily to achieve successful PVC suppression. Investigators define successful PVC suppression only if ≥ 80% absolute reduction in PVC burden is achieved after a drug or intervention. Alternatively, sotalol and/or propafenone could be considered at discretion of electrophysiologists (sotalol dose of at least 120mg twice daily, propafenone 150-300mg tid) if there is a significant concern of safety profile of amiodarone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (20 listed)
- 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)
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 |
|---|---|---|
| Radiofrequency ablationAlso: AblationRFA to achieve PVC suppression will be performed using standard techniques and protocols similar to those patients that do not participate in this clinical study. | Procedure or surgery | Radiofrequency Ablation |
| Amiodarone (Antiarrhythmic drug)Also: AmiodaroneAAD therapy of choice is amiodarone. Amiodarone loading dose of 10 grams is recommended, followed by maintenance dose of 200-400mg daily to achieve successful PVC suppression. Alternatively, sotalol and/or propafenone could be considered at discretion of electrophysiologists (sotalol dose of at least 120mg twice daily, propafenone 150-300mg tid) if there is a significant concern of safety profile of amiodarone. | Drug | Antiarrhythmic Drug |
Primary outcome
Improvement of left ventricular ejection fraction after PVC suppression
Time frame: 12 months
Compare the overall improvement or change in LVEF between RFA and AAD groups.
Responders to PVC suppression strategy
Time frame: 12 months
Assessment of the number of responders (delta LVEF ≥ 10%) after PVC suppression strategies will assess the effectiveness of RFA and AADs to reverse or improve cardiomyopathy induced by frequent PVCs.
3 secondary outcomes
Successful PVC suppression
Time frame: 12 months
Composite Adverse Events
Time frame: 12 months
Composite Arrhythmia Burden
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Derived from this study: PubMed 39445764Torrado J, Sima A, Comstuck C, Kaszala K, Tan A, Koneru J, Frankel DS, Marchlinski F, Kowalski M, Sharma P, Gerstenfeld EP, Vaseghi M, Shivkumar K, Malhotra R, Morillo C, Ellenbogen KA, Huizar JF. Prevalence of frequent premature ventricular contractions and left-ventricular systolic dysfunction in patients receiving Holter monitoring. J Cardiovasc Electrophysiol. 2025 Jan;36(1):54-61. doi: 10.1111/jce.16478. Epub 2024 Oct 24.
- Individual participant dataSharing planned: Yes. This is solely a pilot study of frequent PVCs and cardiomyopathy. Results of this preliminary data will not provide final definitive data, yet investigators will make it available. However, investigators will make clear that this pilot data is not intended to answer benefits of different PVC suppression strategies to avoid misinterpretation or inaccurate conclusions based solely on preliminary data.
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. This study is not recruiting at the moment.
Jose F Huizar, M.D. study director
McGuire VA Medical Center
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Radiofrequency ablation and Amiodarone (Antiarrhythmic drug) in people with Ventricular Premature Beats, Contractions, or Systoles and Cardiomyopathies, run by Hunter Holmes Mcguire Veteran Affairs Medical Center at 11 sites in 2 countries.
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 2 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of left ventricular ejection fraction after PVC suppression (time frame: 12 months). 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?
On the ClinicalTrials.gov record for NCT03228823, which also lists 1 linked publication.
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 14 Apr 2021.