Wolf Parkinson White SyndromeNCT06260384
Wolf-Parkinson-White Syndrome and Asymptomatic Pre-excitation in Africa (a Multicenter WPW African Registry)
An observational study of Wolf Parkinson White Syndrome and Arrythmias, run by Ain Shams University at 1 site in Egypt.
Trial summary
The purpose of this prospective observational study is to characterize the clinical profile of patients with WPW syndrome and patients with asymptomatic WPW pattern on ECG in different African countries and how these patients are managed across Africa Participants would include many different ethnicities at centers… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Wolf Parkinson White Syndrome, Arrythmias
- What is being tested?
- electrocardiogram
- How many people
- 500 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to 31 Oct 2024
- How long will I take part?
- 12 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants are recruited from outpatient cardiology clinics and inpatient cardiology wards at twenty cardiac centers in 17 countries spread across all African regions. They all belong to the Africa Heart Rhythm Association (AFHRA) network, and participants were included if they have preexcitation (WPW) pattern on an ECG either they have symptoms, documented tachyarrhythmias or asymptomatic and accidently discovered
Who may be able to join
- Patients who have a preexcitation (WPW) pattern on an ECG.
Who cannot join
- any participant who does not consent to the study. Any participants who have structural heart disease History of other arrhythmogenic diseases like Brugada syndrome, Arrhythmogenic AR dysplasia, long QT syndrome..etc Any implantable cardiac rhythm devices
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain shams university
Cairo, Outside US, 11851
Nabil M Farag, MD, +201223102180, faragnabil@hotmail.com
lamallam.eps@gmail.com
About this study
Official title: Clinical Profile and Current Strategies in Management of Wolf-Parkinson-White Syndrome and Asymptomatic Pre-excitation in Africa (a Multicenter WPW African Registry)
The purpose of this prospective observational study is to characterize the clinical profile of patients with WPW syndrome and patients with asymptomatic WPW pattern on ECG in different African countries and how these patients are managed across Africa Participants would include many different ethnicities at centers where the number of cardiac patients treated is high. All patients attending outpatient cardiology clinics or referred to Cath Lab for electrophysiological studies who are diagnosed to have a Wolf-Parkinson white pattern on the ECG are either symptomatic or asymptomatic. All patients fulfilling the eligibility criteria will be approached by the research team and asked if they wish to take part in the study.
The exclusion criteria will be any participant who does not consent to the study.
Read more
A baseline cardiovascular history (including hypertension, diabetes, heart failure, coronary artery disease, hyperlipidemia, smoking, valve disease, and arrhythmia) will be recorded.
A detailed history will be taken about symptoms, medications and presence of family history of similar cases or sudden cardiac death 12-lead ECG will be recorded to confirm the presence of pre-excitation and determine the localization of the accessory pathway using the modified Aruda algorithm. This will be done by two of the research teams in each center.
Then other data from the electrophysiological study and ablation will be filled in by the research team from the data systems of each center.
Read the detailed description
A specifically designed electronic report is used and includes the patient's baseline characteristics, symptoms if present, presence of underlying heart disease, family history of any similar conditions, or sudden cardiac death (SCD).
ECG analysis will be done for criteria of WPW pattern, localization of the site of the accessory pathway, and the algorithm used for that; all will be recorded.
Our sample is divided according to clinical presentation into patients with WPW syndrome (those with symptoms or documented tachycardia) and asymptomatic subjects (ventricular pre-excitation on ECG without symptoms).
In patients with WPW syndrome, data will be collected, including symptoms, type of documented tachyarrhythmia, acute management of this arrhythmia on time, and the long-term management strategy, either pharmacological or interventional therapy.
In patients who are referred for electrophysiological (EP) study for mapping and radiofrequency (RF) catheter ablation, all data are recorded, including the method of the study, either fluoroscopic guided or three-dimensional (3D mapping), acute success, site of successful ablation, complications, and long-term success after a one-year follow-up.
Regarding asymptomatic subjects, we collect data on risk stratification, either a noninvasive assessment like a stress electrocardiogram or an invasive electrophysiological (EP) study, and allowance to do exercise and practice sports.
At the end of the study, the performance of each center regarding the management strategy for WPW syndrome was assessed blindly by two European heart rhythm association (EHRA) certified experts in electrophysiology field based on the recent published guidelines of European society of cardiology (ESC).
Socio-economic determinants and health metrics such as the human development index (HDI), health expenditure as a percentage of the gross demographic product (GDP), and the effective health coverage index (UHC) will be compiled together with the EP procedure density of each center to determine the impact of health governance in the management of patients with cardiac pre-excitation. EP procedure density is defined as the ratio between the number of procedures and the years of experience of the index center.
- Conditions
- Wolf Parkinson White Syndrome, Arrythmias
- Being tested
- electrocardiogram
- Keywords
- WPW syndrome, ECG, RF ablation, Africa
- Medical subject headings
- Wolff-Parkinson-White Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrocardiogramOther
it is a non-invasive study to diagnose criteria of Wolf-Parkinson-Wall syndrome and detect any arrhythmias
| Study group | Role | What they receive |
|---|---|---|
| All patients attending outpatient cardiology clinics or referred for EP study | Participants will be recruited from outpatient cardiology clinics and inpatient cardiology wards at twenty cardiac centers in 17 countries spread across all African regions. They all belong to the Africa Heart Rhythm Association (AFHRA) network, and participants are included if they have a preexcitation (WPW) pattern on an ECG. A written consent will be obtained, and an ethical clearance from each center will be obtained from their institution. The exclusion criteria were a lack of consent. Receives: Other: electrocardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
No recurrence of symptoms
Disappearance of symptoms after proper management either pharmacological or intervention method based on ESC guidelines on management of supraventricular tachycardia
Measured: 12 months
Assessment of performance outcome of each center
Assessment of quality of management of each shared center in managing the study population based on the recent guidelines
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 posted15 Feb 2024
- Study start1 May 2022
- Primary completion31 May 2024 (estimated)
- Study completion31 Oct 2024 (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 Wolf Parkinson White SyndromeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- lamyaa E Allam, MD, Principal investigator, Ain shams university,Cairo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260384
- Sponsor's protocol ID
- FMASU R 139/2022
- Status last verified
- Feb 2024
- First submitted
- 7 Feb 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared except the protocol and informed consent at the beginning of the study to keep it safe as researchers are from different countries. they all signed an agreement letter for that
Publications
Svendsen JH, Dagres N, Dobreanu D, Bongiorni MG, Marinskis G, Blomstrom-Lundqvist C; Scientific Initiatives Committee, European Heart Rhythm Association. Current strategy for treatment of patients with Wolff-Parkinson-White syndrome and asymptomatic preexcitation in Europe: European Heart Rhythm Association survey. Europace. 2013 May;15(5):750-3. doi: 10.1093/europace/eut094.
PubMed 23625944Brugada J, Katritsis DG, Arbelo E, Arribas F, Bax JJ, Blomstrom-Lundqvist C, Calkins H, Corrado D, Deftereos SG, Diller GP, Gomez-Doblas JJ, Gorenek B, Grace A, Ho SY, Kaski JC, Kuck KH, Lambiase PD, Sacher F, Sarquella-Brugada G, Suwalski P, Zaza A; ESC Scientific Document Group. 2019 ESC Guidelines for the management of patients with supraventricular tachycardiaThe Task Force for the management of patients with supraventricular tachycardia of the European Society of Cardiology (ESC). Eur Heart J. 2020 Feb 1;41(5):655-720. doi: 10.1093/eurheartj/ehz467. No abstract available.
PubMed 31504425
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Profile and Current Strategies in Management of Wolf-Parkinson-White Syndrome and Asymptomatic Pre-excitation in Africa (a Multicenter WPW African Registry)
- ClinicalTrials.gov ID
- NCT06260384
- Acronym / sponsor ID
- FMASU R 139/2022
- Conditions
- Wolf Parkinson White Syndrome, Arrythmias
- Keywords
- WPW syndrome, ECG, RF ablation, Africa
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 15 Feb 2024 (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.
The purpose of this prospective observational study is to characterize the clinical profile of patients with WPW syndrome and patients with asymptomatic WPW pattern on ECG in different African countries and how these patients are managed across Africa Participants would include many different ethnicities at centers where the number of cardiac patients treated is high. All patients attending outpatient cardiology clinics or referred to Cath Lab for electrophysiological studies who are diagnosed to have a Wolf-Parkinson white pattern on the ECG are either symptomatic or asymptomatic. All patients fulfilling the eligibility criteria will be approached by the research team and asked if they wish to take part in the study.
The exclusion criteria will be any participant who does not consent to the study.
A baseline cardiovascular history (including hypertension, diabetes, heart failure, coronary artery disease, hyperlipidemia, smoking, valve disease, and arrhythmia) will be recorded.
A detailed history will be taken about symptoms, medications and presence of family history of similar cases or sudden cardiac death 12-lead ECG will be recorded to confirm the presence of pre-excitation and determine the localization of the accessory pathway using the modified Aruda algorithm. This will be done by two of the research teams in each center.
Then other data from the electrophysiological study and ablation will be filled in by the research team from the data systems of each center.
Detailed description
A specifically designed electronic report is used and includes the patient's baseline characteristics, symptoms if present, presence of underlying heart disease, family history of any similar conditions, or sudden cardiac death (SCD).
ECG analysis will be done for criteria of WPW pattern, localization of the site of the accessory pathway, and the algorithm used for that; all will be recorded.
Our sample is divided according to clinical presentation into patients with WPW syndrome (those with symptoms or documented tachycardia) and asymptomatic subjects (ventricular pre-excitation on ECG without symptoms).
In patients with WPW syndrome, data will be collected, including symptoms, type of documented tachyarrhythmia, acute management of this arrhythmia on time, and the long-term management strategy, either pharmacological or interventional therapy.
In patients who are referred for electrophysiological (EP) study for mapping and radiofrequency (RF) catheter ablation, all data are recorded, including the method of the study, either fluoroscopic guided or three-dimensional (3D mapping), acute success, site of successful ablation, complications, and long-term success after a one-year follow-up.
Regarding asymptomatic subjects, we collect data on risk stratification, either a noninvasive assessment like a stress electrocardiogram or an invasive electrophysiological (EP) study, and allowance to do exercise and practice sports.
At the end of the study, the performance of each center regarding the management strategy for WPW syndrome was assessed blindly by two European heart rhythm association (EHRA) certified experts in electrophysiology field based on the recent published guidelines of European society of cardiology (ESC).
Socio-economic determinants and health metrics such as the human development index (HDI), health expenditure as a percentage of the gross demographic product (GDP), and the effective health coverage index (UHC) will be compiled together with the EP procedure density of each center to determine the impact of health governance in the management of patients with cardiac pre-excitation. EP procedure density is defined as the ratio between the number of procedures and the years of experience of the index center.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients attending outpatient cardiology clinics or referred for EP study | – | Other: electrocardiogramParticipants will be recruited from outpatient cardiology clinics and inpatient cardiology wards at twenty cardiac centers in 17 countries spread across all African regions. They all belong to the Africa Heart Rhythm Association (AFHRA) network, and participants are included if they have a preexcitation (WPW) pattern on an ECG. A written consent will be obtained, and an ethical clearance from each center will be obtained from their institution. The exclusion criteria were a lack of consent. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants are recruited from outpatient cardiology clinics and inpatient cardiology wards at twenty cardiac centers in 17 countries spread across all African regions. They all belong to the Africa Heart Rhythm Association (AFHRA) network, and participants were included if they have preexcitation (WPW) pattern on an ECG either they have symptoms, documented tachyarrhythmias or asymptomatic and accidently discovered
Key inclusion criteria (1 listed)
- Patients who have a preexcitation (WPW) pattern on an ECG.
Key exclusion criteria (1 listed)
- any participant who does not consent to the study. Any participants who have structural heart disease History of other arrhythmogenic diseases like Brugada syndrome, Arrhythmogenic AR dysplasia, long QT syndrome..etc Any implantable cardiac rhythm devices
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 |
|---|---|---|
| electrocardiogramit is a non-invasive study to diagnose criteria of Wolf-Parkinson-Wall syndrome and detect any arrhythmias | Other | All patients attending outpatient cardiology clinics or referred for EP study |
Primary outcome
No recurrence of symptoms
Time frame: 12 months
Disappearance of symptoms after proper management either pharmacological or intervention method based on ESC guidelines on management of supraventricular tachycardia
Assessment of performance outcome of each center
Time frame: 12 months
Assessment of quality of management of each shared center in managing the study population based on the recent guidelines
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Results publication: PubMed 23625944Svendsen JH, Dagres N, Dobreanu D, Bongiorni MG, Marinskis G, Blomstrom-Lundqvist C; Scientific Initiatives Committee, European Heart Rhythm Association. Current strategy for treatment of patients with Wolff-Parkinson-White syndrome and asymptomatic preexcitation in Europe: European Heart Rhythm Association survey. Europace. 2013 May;15(5):750-3. doi: 10.1093/europace/eut094.
- Results publication: PubMed 31504425Brugada J, Katritsis DG, Arbelo E, Arribas F, Bax JJ, Blomstrom-Lundqvist C, Calkins H, Corrado D, Deftereos SG, Diller GP, Gomez-Doblas JJ, Gorenek B, Grace A, Ho SY, Kaski JC, Kuck KH, Lambiase PD, Sacher F, Sarquella-Brugada G, Suwalski P, Zaza A; ESC Scientific Document Group. 2019 ESC Guidelines for the management of patients with supraventricular tachycardiaThe Task Force for the management of patients with supraventricular tachycardia of the European Society of Cardiology (ESC). Eur Heart J. 2020 Feb 1;41(5):655-720. doi: 10.1093/eurheartj/ehz467. No abstract available.
- Individual participant dataSharing planned: No. Data will not be shared except the protocol and informed consent at the beginning of the study to keep it safe as researchers are from different countries. they all signed an agreement letter for that
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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.
lamyaa E Allam, MD principal investigator
Ain shams university,Cairo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wolf Parkinson White Syndrome and Arrythmias, 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 1 inclusion and 1 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 26 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lamyaa E Allam, MD (+201004002084, lamyaa_allam@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
No recurrence of symptoms (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 NCT06260384, 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 26 Feb 2024.