Premature Ventricular ComplexesNCT06864429
Impact of Catheter Ablation of Frequent Premature Ventricular Complexes in Treating Subtle Left Cardiomyopathy
A study testing Radiofrequency catheter ablation in people with Premature Ventricular Complexes and Ventricular Arrhythmias, run by Ain Shams University at 1 site in Egypt.
Trial summary
Throughout the past decade, there were no straightforward recommendations regarding the management of asymptomatic high-burden Premature ventricular complexes (PVCs) in structurally normal heart extending from the European Society of Cardiology (ESC) guidelines of management of ventricular arrhythmias in 2014, passing… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Premature Ventricular Complexes, Ventricular Arrhythmias
- What is being tested?
- Radiofrequency catheter ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 28 Aug 2024
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Asymptomatic patients with frequent idiopathic PVCs, defined as PVCs burden of ≥ 20% of total beats in Holter ECG monitoring in the structurally normal heart as being assessed by conventional 2D echocardiography and normal 12 lead surface ECG.
- Impaired LV GLS by 2D speckle tracking (GLS > -16 %).
- Patients willing and capable of providing informed consent
Who cannot join
- Multiple co-morbidities that may be potential factors affecting functional capacity including anemia, Chronic obstructive pulmonary disease (COPD), interstitial pulmonary fibrosis, bronchial asthma, Cerebrovascular stroke (CVS), skeletomuscular abnormalities or chronic kidney disease (CKD).
- Symptoms including but not limited to fatigue, palpitations, dyspnea, chest pain, dizziness, syncope, presyncope, or functional limitation that was defined as less than the lower limit of predicted 6-minute walk distance (6 MWD).
- Any electrolyte abnormalities, abnormal arterial blood gases, and/or abnormal thyroid profile.
- Ischemic heart disease (ISHD), in our study ISHD was defined as patients with a previous history of Myocardial infarction, acute coronary syndrome, previous revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG), or objective evidence of myocardial ischemia including noninvasive functional assessment or coronary angiography showing significant stenosis > 50%.
- Symptomatic or asymptomatic structural heart disease including any congenital heart diseases, significant valvular lesion defined as primary or secondary valvular lesion causing abnormal loading condition, or more than grade I diastolic dysfunction.
- Any symptomatic or asymptomatic phenotype of cardiomyopathies.
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- Polymorphic PVCs.
- Atrial fibrillation.
- Positive family history of sudden cardiac death.
- Heart failure including heart failure with preserved ejection fraction (HFpEF), heart failure with mildly reduced ejection fraction (HFmrEF), and heart failure with reduced ejection fraction (HFrEF).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Catheter Ablation of Frequent Asymptomatic Idiopathic Premature Ventricular Complexes in Treating Latent Left Ventricular Systolic Dysfunction As Being Assessed by Speckle Tracking of LV Global Longitudinal Strain
Throughout the past decade, there were no straightforward recommendations regarding the management of asymptomatic high-burden Premature ventricular complexes (PVCs) in structurally normal heart extending from the European Society of Cardiology (ESC) guidelines of management of ventricular arrhythmias in 2014, passing by the American Heart Association (AHA), American College of Cardiology (ACC), and Heart Rhythm Association (HRA) guidelines 2017, and reaching to the recent ESC guidelines in 2022 that declared overtly that there is a gap of evidence regarding management of asymptomatic high burden PVCs in structurally normal heart.
The goal of this clinical trial is to know if other imaging modalities rather than the conventional Two-dimension (2D) echocardiography can guide the treatment strategy of high-burden idiopathic premature ventricular complexes (PVCs). In our clinical trial, we used 2D speckle tracking of left ventricular (LV) global longitudinal strain (GLS) as an indicator for subtle LV systolic dysfunction in patients with structurally normal heart by conventional echocardiography.
Read more
The main questions the trial aims to answer are:
- Is radiofrequency catheter ablation an effective method in the treatment of early subtle myocardial dysfunction in patients with normal left ventricle ejection fraction (LVEF) and internal dimensions guided by 2D STE of GLS before progression into overt LV systolic dysfunction?
- Is there a correlation between radiofrequency catheter ablation of asymptomatic frequent idiopathic PVCs and improvement of patient functional capacity as an indicator for subconscious adaptation?
- Is there a correlation between PVC burden and the degree of impairment of GLS?
Researchers will compare group A (control group) and group B (ablation group) to see if there is a significant difference between them regarding global longitudinal strain.
Participants will be randomized into two groups each containing 20 patients. Group A (Control group): will be subjected to the standard of care being regular follow-up of symptom status and left ventricular ejection fraction (LVEF) Group B (ablation group): will be scheduled for PVC ablation.
Read the detailed description
The clinical trial was conducted from June 2023 to August 2024. A total of 218 patients entered the screening phase. Of that participant pool, 116 patients did not fulfill the eligibility criteria since 90 patients were symptomatic, 33 patients had more than one PVC morphology in Holter ECG monitoring, 10 patients had episodes of atrial fibrillation (AF) in Holter ECG monitoring, 2 patients were diagnosed with chronic obstructive pulmonary disease (COPD), 1 patient had chronic kidney disease (CKD).
The other 100 patients continued with the subsequent stage of assessment of LV GLS, as mentioned in the outlined methodology. Of this cohort, 60 patients were excluded from the study because they did not meet the criteria for randomization, as they showed normal LV GLS ≥ -16%.
Accordingly, our study was conducted on 40 patients meeting the inclusion criteria mentioned. Those patients were further randomized into two groups each containing 20 patients.
Group A (Control group): subjected to the standard of care being regular follow-up of symptom status and left ventricular ejection fraction (LVEF) Group B (ablation group): scheduled for PVC ablation.
After a minimum duration of 3 months all participants were applied to follow-up assessment of symptoms status, 6-minute walk test (6MWT), PVC burden by Holter ECG monitoring, LV GLS by speckle tracking Echocardiography (STE).
- Being tested
- Radiofrequency catheter ablation
- Keywords
- catheter ablation, radiofrequency ablation, Premature ventricular complexes, global longitudinal strain, PVCs induced cardiomyopathy, Idiopathic PVCs, Speckle tracking
- Medical subject headings
- Ventricular Premature Complexes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency catheter ablationProcedure or surgery
Radiofrequency (RF) catheter ablation is a minimally invasive procedure that targets and eliminates certain types of cardiac arrhythmias. RF became effective as the first-line treatment for ventricular arrhythmias in some circumstances.
| Study group | Role | What they receive |
|---|---|---|
| group A (control arm) | No intervention | Group A is the control arm that will be applied to the standard of care treatment which is follow-up of symptoms status and left ventricular ejection fraction as per the recommendation of ESC guidelines of management of ventricular arrhythmias and sudden cardiac death published in 2022. |
| Group B (ablation arm) | Active comparator | Group B is the ablation arm that will be scheduled for radiofrequency catheter ablation of PVCs. Receives: Procedure: Radiofrequency catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
global longitudinal strain
change of left ventricular global longitudinal strain was an indicator of the effectiveness of radiofrequency ablation in the treatment of subtle LV systolic dysfunction and prevention of further progression into overt cardiomyopathy.
Measured: minimum of 3 months after (intervention) radio frequency ablation
Secondary outcomes (2)
functional capacity
The trial aims to assess the correlation between radiofrequency catheter ablation of asymptomatic frequent idiopathic PVCs and change of patient functional capacity that is evaluated by a 6-minute walk test as an indicator for subconscious adaptation
Measured: minimum of 3 months after (intervention) radio frequency ablation
PVC burden
The trial aims to assess the correlation between PVC burden and the degree of impairment of GLS
Measured: minimum of 3 months after (intervention) radio frequency ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start1 Jun 2023
- Primary completion23 May 2024
- Study completion28 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ventricular ComplexesStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- group B ( ablation arm), will be applied for radiofrequency catheter ablation of PVCs as a treatment strategy.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06864429
- Sponsor's protocol ID
- FMASU MD102/2023
- Status last verified
- Jan 2025
- First submitted
- 14 Feb 2025
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Catheter Ablation of Frequent Asymptomatic Idiopathic Premature Ventricular Complexes in Treating Latent Left Ventricular Systolic Dysfunction As Being Assessed by Speckle Tracking of LV Global Longitudinal Strain
- ClinicalTrials.gov ID
- NCT06864429
- Acronym / sponsor ID
- FMASU MD102/2023
- Keywords
- catheter ablation, radiofrequency ablation, Premature ventricular complexes, global longitudinal strain, PVCs induced cardiomyopathy, Idiopathic PVCs, Speckle tracking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 23 May 2024 (actual)
- Study completion
- 28 Aug 2024 (actual)
- First posted
- 7 Mar 2025 (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.
Throughout the past decade, there were no straightforward recommendations regarding the management of asymptomatic high-burden Premature ventricular complexes (PVCs) in structurally normal heart extending from the European Society of Cardiology (ESC) guidelines of management of ventricular arrhythmias in 2014, passing by the American Heart Association (AHA), American College of Cardiology (ACC), and Heart Rhythm Association (HRA) guidelines 2017, and reaching to the recent ESC guidelines in 2022 that declared overtly that there is a gap of evidence regarding management of asymptomatic high burden PVCs in structurally normal heart.
The goal of this clinical trial is to know if other imaging modalities rather than the conventional Two-dimension (2D) echocardiography can guide the treatment strategy of high-burden idiopathic premature ventricular complexes (PVCs). In our clinical trial, we used 2D speckle tracking of left ventricular (LV) global longitudinal strain (GLS) as an indicator for subtle LV systolic dysfunction in patients with structurally normal heart by conventional echocardiography.
The main questions the trial aims to answer are:
- Is radiofrequency catheter ablation an effective method in the treatment of early subtle myocardial dysfunction in patients with normal left ventricle ejection fraction (LVEF) and internal dimensions guided by 2D STE of GLS before progression into overt LV systolic dysfunction?
- Is there a correlation between radiofrequency catheter ablation of asymptomatic frequent idiopathic PVCs and improvement of patient functional capacity as an indicator for subconscious adaptation?
- Is there a correlation between PVC burden and the degree of impairment of GLS?
Researchers will compare group A (control group) and group B (ablation group) to see if there is a significant difference between them regarding global longitudinal strain.
Participants will be randomized into two groups each containing 20 patients. Group A (Control group): will be subjected to the standard of care being regular follow-up of symptom status and left ventricular ejection fraction (LVEF) Group B (ablation group): will be scheduled for PVC ablation.
Detailed description
The clinical trial was conducted from June 2023 to August 2024. A total of 218 patients entered the screening phase. Of that participant pool, 116 patients did not fulfill the eligibility criteria since 90 patients were symptomatic, 33 patients had more than one PVC morphology in Holter ECG monitoring, 10 patients had episodes of atrial fibrillation (AF) in Holter ECG monitoring, 2 patients were diagnosed with chronic obstructive pulmonary disease (COPD), 1 patient had chronic kidney disease (CKD).
The other 100 patients continued with the subsequent stage of assessment of LV GLS, as mentioned in the outlined methodology. Of this cohort, 60 patients were excluded from the study because they did not meet the criteria for randomization, as they showed normal LV GLS ≥ -16%.
Accordingly, our study was conducted on 40 patients meeting the inclusion criteria mentioned. Those patients were further randomized into two groups each containing 20 patients.
Group A (Control group): subjected to the standard of care being regular follow-up of symptom status and left ventricular ejection fraction (LVEF) Group B (ablation group): scheduled for PVC ablation.
After a minimum duration of 3 months all participants were applied to follow-up assessment of symptoms status, 6-minute walk test (6MWT), PVC burden by Holter ECG monitoring, LV GLS by speckle tracking Echocardiography (STE).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- group B ( ablation arm), will be applied for radiofrequency catheter ablation of PVCs as a treatment strategy.
| Arm | Type | Receives |
|---|---|---|
| group A (control arm) | No intervention | –Group A is the control arm that will be applied to the standard of care treatment which is follow-up of symptoms status and left ventricular ejection fraction as per the recommendation of ESC guidelines of management of ventricular arrhythmias and sudden cardiac death published in 2022. |
| Group B (ablation arm) | Active comparator | Procedure: Radiofrequency catheter ablationGroup B is the ablation arm that will be scheduled for radiofrequency catheter ablation of PVCs. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Asymptomatic patients with frequent idiopathic PVCs, defined as PVCs burden of ≥ 20% of total beats in Holter ECG monitoring in the structurally normal heart as being assessed by conventional 2D echocardiography and normal 12 lead surface ECG.
- Impaired LV GLS by 2D speckle tracking (GLS > -16 %).
- Patients willing and capable of providing informed consent
Key exclusion criteria (10 listed)
- Multiple co-morbidities that may be potential factors affecting functional capacity including anemia, Chronic obstructive pulmonary disease (COPD), interstitial pulmonary fibrosis, bronchial asthma, Cerebrovascular stroke (CVS), skeletomuscular abnormalities or chronic kidney disease (CKD).
- Symptoms including but not limited to fatigue, palpitations, dyspnea, chest pain, dizziness, syncope, presyncope, or functional limitation that was defined as less than the lower limit of predicted 6-minute walk distance (6 MWD).
- Any electrolyte abnormalities, abnormal arterial blood gases, and/or abnormal thyroid profile.
- Ischemic heart disease (ISHD), in our study ISHD was defined as patients with a previous history of Myocardial infarction, acute coronary syndrome, previous revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG), or objective evidence of myocardial ischemia including noninvasive functional assessment or coronary angiography showing significant stenosis > 50%.
- Symptomatic or asymptomatic structural heart disease including any congenital heart diseases, significant valvular lesion defined as primary or secondary valvular lesion causing abnormal loading condition, or more than grade I diastolic dysfunction.
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 catheter ablationRadiofrequency (RF) catheter ablation is a minimally invasive procedure that targets and eliminates certain types of cardiac arrhythmias. RF became effective as the first-line treatment for ventricular arrhythmias in some circumstances. | Procedure or surgery | Group B (ablation arm) |
Primary outcome
global longitudinal strain
Time frame: minimum of 3 months after (intervention) radio frequency ablation
change of left ventricular global longitudinal strain was an indicator of the effectiveness of radiofrequency ablation in the treatment of subtle LV systolic dysfunction and prevention of further progression into overt cardiomyopathy.
2 secondary outcomes
functional capacity
Time frame: minimum of 3 months after (intervention) radio frequency ablation
PVC burden
Time frame: minimum of 3 months after (intervention) radio frequency ablation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency catheter ablation in people with Premature Ventricular Complexes and Ventricular Arrhythmias, run by Ain Shams University at 1 site in Egypt.
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 3 inclusion and 10 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: finished, as of the sponsor's last update on 7 Mar 2025. 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 Egypt. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
global longitudinal strain (time frame: minimum of 3 months after (intervention) radio frequency ablation). 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 7 Mar 2025.