Left Ventricular Function, ArrhythmiaNCT05225662
Impact of Radiofrequency Ablation on Left Ventricular Function in Supraventricular Tachyarrhythmias Patient Using Speckle Tracking Echocardiography
An observational study of Left Ventricular Function, Arrhythmia, run by Assiut University.
Trial summary
In this study, we aimed to evaluate atrial and ventricular function in supraventricular tachyarrhythmia patients before and 3 months after RFA using 2DSTE. Read more about this study
- Who is it for?
- Ages Up to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Left Ventricular Function, Arrhythmia
- What is being tested?
- radiofrequency ablation
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Feb 2022to Mar 2025
- Phase
- Observational
- 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 Up to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: all patient with supraventricular tachyarhythmia undergoing radiofrequency ablation
Who may be able to join
- Patients with AVNRT or AVRT undergoing RF ablation
Who cannot join
- - Patient with bundle blocks
- Coronary artery disease
- Diastolic dysfunction ≥grade 2
- Left ventricular hypertrophy
- Diabetes mellitus
- Chronic renal failure (GFR<45ml\min)
- Moderate to severe valvular heart disease
- Patient with bad echo window
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Study of the Impact of Radiofrequency Ablation on Left Ventricular Function in Supraventricular Tachyarrhythmias Patient Using Speckle Tracking Echocardiography
In this study, we aimed to evaluate atrial and ventricular function in supraventricular tachyarrhythmia patients before and 3 months after RFA using 2DSTE.
Read the detailed description
Two-dimensional speckle-tracking echocardiography (2DSTE) is a known technique for the evaluation of myocardial function in many conditions. The longitudinal deformation of the left ventricular (LV) mainly occurs in the subendocardial level which is sensitive to injury and it may be used to identify sub-clinical LV dysfunction in cardiomyopathies. Global longitudinal strain, strain rate (SR), and torsion measurements are very promising to identify patients with mild systolic and diastolic dysfunctions which are not reflected in reduced EF.
Tachyarrhythmias that are persistent and recurrent can lead to LV dysfunction. Dyssynchrony is another mechanism that may cause LV dysfunction, as in the case of Wolf Parkinson Syndrome (WPW ). It might be explained by the "collision" of electric stimuli through the normal atrioventricular conduction system and along the accessory pathway (AP) during the systolic phase. 2DSTE has been used to investigate the characteristics of WPW syndrome and confirm the presence of LV dyssynchrony in this condition.
Lelakowski et al. showed that RFA improves LV systolic and diastolic functions in patients with Atrioventricular Nodal Reentry tachycardia (AVNRT).
Recurrent AVNRT attacks increase atrial pressure, leading to elevated atrial wall stress, which causes negative remodeling and systolic impairment. It has been shown that left atrial(LA) functions improved after Radiofrequency ablation RFA, along with LA volume reduction in atrial fibrillation/flutter patients.
the small number of patients and lacking using advanced accurate techniques lead to currently insufficient data in the literature regarding changes in cardiac function following AVNRT \& AVRT ablation and whether LV dyssynchrony is reversible after ablation therapy of AVRT or not.
- Conditions
- Left Ventricular Function, Arrhythmia
- Being tested
- radiofrequency ablation
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiofrequency ablationDiagnostic test
Also called speckle tracking
Mesuring change in Speckle tracking analysis before and after the radiofreqency ablation
What is being measured
The primary outcome is the main question the study is designed to answer.
left ventricular systolic function
assessment of left ventricular systolic function by speckle tracking before and after radiofrequency ablation
Measured: baseline and 3 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study startFeb 2022 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Left Ventricular Function, ArrhythmiaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Tantawy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225662
- Sponsor's protocol ID
- systolic function, ablation
- Status last verified
- Jan 2022
- First submitted
- 14 Jan 2022
- Last updated
- 4 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nagai T, Hamabe A, Arakawa J, Tabata H, Nishioka T. The impact of left ventricular deformation and dyssynchrony on improvement of left ventricular ejection fraction following radiofrequency catheter ablation in Wolff-Parkinson-White syndrome: A comprehensive study by speckle tracking echocardiography. Echocardiography. 2017 Nov;34(11):1610-1616. doi: 10.1111/echo.13691. Epub 2017 Sep 19.
PubMed 28929532Lelakowski J, Dreher A, Majewski J, Bednarek J, Pasowicz M. [Influence of the treatment of the atrioventricular reentry tachycardia by RF catheter ablation on the left ventricular systolic and diastolic function and exercise capacity]. Wiad Lek. 2009;62(2):71-80. Polish.
PubMed 20141053
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Impact of Radiofrequency Ablation on Left Ventricular Function in Supraventricular Tachyarrhythmias Patient Using Speckle Tracking Echocardiography
- ClinicalTrials.gov ID
- NCT05225662
- Acronym / sponsor ID
- systolic function, ablation
- Conditions
- Left Ventricular Function, Arrhythmia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Feb 2022 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 4 Feb 2022 (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.
In this study, we aimed to evaluate atrial and ventricular function in supraventricular tachyarrhythmia patients before and 3 months after RFA using 2DSTE.
Detailed description
Two-dimensional speckle-tracking echocardiography (2DSTE) is a known technique for the evaluation of myocardial function in many conditions. The longitudinal deformation of the left ventricular (LV) mainly occurs in the subendocardial level which is sensitive to injury and it may be used to identify sub-clinical LV dysfunction in cardiomyopathies. Global longitudinal strain, strain rate (SR), and torsion measurements are very promising to identify patients with mild systolic and diastolic dysfunctions which are not reflected in reduced EF.
Tachyarrhythmias that are persistent and recurrent can lead to LV dysfunction. Dyssynchrony is another mechanism that may cause LV dysfunction, as in the case of Wolf Parkinson Syndrome (WPW ). It might be explained by the "collision" of electric stimuli through the normal atrioventricular conduction system and along the accessory pathway (AP) during the systolic phase. 2DSTE has been used to investigate the characteristics of WPW syndrome and confirm the presence of LV dyssynchrony in this condition.
Lelakowski et al. showed that RFA improves LV systolic and diastolic functions in patients with Atrioventricular Nodal Reentry tachycardia (AVNRT).
Recurrent AVNRT attacks increase atrial pressure, leading to elevated atrial wall stress, which causes negative remodeling and systolic impairment. It has been shown that left atrial(LA) functions improved after Radiofrequency ablation RFA, along with LA volume reduction in atrial fibrillation/flutter patients.
the small number of patients and lacking using advanced accurate techniques lead to currently insufficient data in the literature regarding changes in cardiac function following AVNRT \& AVRT ablation and whether LV dyssynchrony is reversible after ablation therapy of AVRT or not.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patient with supraventricular tachyarhythmia undergoing radiofrequency ablation
Key inclusion criteria (1 listed)
- Patients with AVNRT or AVRT undergoing RF ablation
Key exclusion criteria (8 listed)
- - Patient with bundle blocks
- Coronary artery disease
- Diastolic dysfunction ≥grade 2
- Left ventricular hypertrophy
- Diabetes mellitus
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: speckle trackingMesuring change in Speckle tracking analysis before and after the radiofreqency ablation | Diagnostic test | – |
Primary outcome
left ventricular systolic function
Time frame: baseline and 3 months later
assessment of left ventricular systolic function by speckle tracking before and after radiofrequency ablation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
- Background: PubMed 28929532Nagai T, Hamabe A, Arakawa J, Tabata H, Nishioka T. The impact of left ventricular deformation and dyssynchrony on improvement of left ventricular ejection fraction following radiofrequency catheter ablation in Wolff-Parkinson-White syndrome: A comprehensive study by speckle tracking echocardiography. Echocardiography. 2017 Nov;34(11):1610-1616. doi: 10.1111/echo.13691. Epub 2017 Sep 19.
- Background: PubMed 20141053Lelakowski J, Dreher A, Majewski J, Bednarek J, Pasowicz M. [Influence of the treatment of the atrioventricular reentry tachycardia by RF catheter ablation on the left ventricular systolic and diastolic function and exercise capacity]. Wiad Lek. 2009;62(2):71-80. Polish.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Ventricular Function, Arrhythmia, run by Assiut University.
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 1 inclusion and 8 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 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marwa Tantawy, master (01065604240, drmarwatantawy7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
left ventricular systolic function (time frame: baseline and 3 months later). 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 NCT05225662, which also lists 2 linked publications.
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 4 Feb 2022.