CardiomyopathiesNCT05105516
Diagnosis Of Early Cardiac Dysfunction in Patients With Idiopathic Frequent Monomorphic PVCs
A study testing Ablation in people with Cardiomyopathies, run by Assiut University at 1 site in Egypt.
Trial summary
Diagnosis Of Early Cardiac Dysfunction in Patients With Idiopathic Frequent Monomorphic PVCs and effect of ablation and comparison between different sites of ablation Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cardiomyopathies
- What is being tested?
- Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to Nov 2025
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients of sample size admitted to the cardiology department of Assiut university hospital for ablation of idiopathic frequent monomorphic PVCs
Who cannot join
- Patients with well-known factors of cardiac dysfunctions, including high blood pressure (over 140/90 mmHg), hypertrophic cardiomyopathy, left ventricular hypertrophy, bundle branch block, severe valvular disease, complete heart block, and previous CABG.
Trial locations and contacts
1 site in 1 country.
Salah Atta, prof contact
About this study
Official title: Diagnosis Of Early Cardiac Dysfunction in Patients With Idiopathic Frequent Monomorphic PVCs and Effect Effect of Ablation and Comparison Between Different Sites of Ablation
Diagnosis Of Early Cardiac Dysfunction in Patients With Idiopathic Frequent Monomorphic PVCs and effect of ablation and comparison between different sites of ablation
Read the detailed description
- Apply the speckle myocardial tracking technology to early diagnose dysfunction in patients with idiopathic frequent monomorphic PVCs
- Assessment of cardiac function before and after ablation and comparison before and after ablation and between sites of origin of the PVCs as diagnosed by the electrophysiologic and 3d mapping techniques that may be more confirmed by successful ablation whenever achieved
- Conditions
- Cardiomyopathies
- Being tested
- Ablation
- Medical subject headings
- Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AblationProcedure or surgery
Ablation of ectopic foci causing PVCs
| Study group | Role | What they receive |
|---|---|---|
| Ablation | Other | Comparison between different sites of ablation Receives: Procedure: Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Detection of early cardiac dysfunction in patients with idiopathic frequent monomorphic PVCs .
- Assessment of cardiac function in patients with idiopathic frequent monomorphic PVCs post - ablation and patients on medical treatment
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start1 Nov 2022 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionNov 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 CardiomyopathiesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Usama Mohammed Tony, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105516
- Sponsor's protocol ID
- Cardiomyopathy in PVCs
- Status last verified
- Jun 2022
- First submitted
- 25 Oct 2021
- Last updated
- 3 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Latchamsetty R, Bogun F. Premature Ventricular Complex-Induced Cardiomyopathy. JACC Clin Electrophysiol. 2019 May;5(5):537-550. doi: 10.1016/j.jacep.2019.03.013.
PubMed 31122375Sharma E, Arunachalam K, Di M, Chu A, Maan A. PVCs, PVC-Induced Cardiomyopathy, and the Role of Catheter Ablation. Crit Pathw Cardiol. 2017 Jun;16(2):76-80. doi: 10.1097/HPC.0000000000000106.
PubMed 28509708
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis Of Early Cardiac Dysfunction in Patients With Idiopathic Frequent Monomorphic PVCs and Effect Effect of Ablation and Comparison Between Different Sites of Ablation
- ClinicalTrials.gov ID
- NCT05105516
- Acronym / sponsor ID
- Cardiomyopathy in PVCs
- Conditions
- Cardiomyopathies
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 3 Nov 2021 (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.
Diagnosis Of Early Cardiac Dysfunction in Patients With Idiopathic Frequent Monomorphic PVCs and effect of ablation and comparison between different sites of ablation
Detailed description
- Apply the speckle myocardial tracking technology to early diagnose dysfunction in patients with idiopathic frequent monomorphic PVCs
- Assessment of cardiac function before and after ablation and comparison before and after ablation and between sites of origin of the PVCs as diagnosed by the electrophysiologic and 3d mapping techniques that may be more confirmed by successful ablation whenever achieved
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ablation | Other | Procedure: AblationComparison between different sites of ablation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients of sample size admitted to the cardiology department of Assiut university hospital for ablation of idiopathic frequent monomorphic PVCs
Key exclusion criteria (1 listed)
- Patients with well-known factors of cardiac dysfunctions, including high blood pressure (over 140/90 mmHg), hypertrophic cardiomyopathy, left ventricular hypertrophy, bundle branch block, severe valvular disease, complete heart block, and previous CABG.
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 |
|---|---|---|
| AblationAblation of ectopic foci causing PVCs | Procedure or surgery | Ablation |
Primary outcome
• Detection of early cardiac dysfunction in patients with idiopathic frequent monomorphic PVCs .
Time frame: Baseline
• Assessment of cardiac function in patients with idiopathic frequent monomorphic PVCs post - ablation and patients on medical treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Background: PubMed 31122375Latchamsetty R, Bogun F. Premature Ventricular Complex-Induced Cardiomyopathy. JACC Clin Electrophysiol. 2019 May;5(5):537-550. doi: 10.1016/j.jacep.2019.03.013.
- Background: PubMed 28509708Sharma E, Arunachalam K, Di M, Chu A, Maan A. PVCs, PVC-Induced Cardiomyopathy, and the Role of Catheter Ablation. Crit Pathw Cardiol. 2017 Jun;16(2):76-80. doi: 10.1097/HPC.0000000000000106.
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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.
Salah Atta, prof contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ablation in people with Cardiomyopathies, run by Assiut 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 3 Jun 2022. 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 Mohammed Usama (+201013001256, mohammedusama502@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Detection of early cardiac dysfunction in patients with idiopathic frequent monomorphic PVCs . (time frame: Baseline). 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 NCT05105516, 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 3 Jun 2022.