Tachycardia, VentricularNCT05086510
Ablation Targets of Scar-related Ventricular Tachycardia Identified by Dynamic Functional Substrate Mapping
A study testing Radiofrequency ablation in people with Tachycardia, Ventricular, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims at comparing the recurrence rates of ventricular tachycardia ablated after being mapped by 2 different techniques. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tachycardia, Ventricular
- What is being tested?
- Radiofrequency 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
- 28 Oct 2021to 26 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- • Patients with structural heart disease; previous myocardial infarction, left ventricular dilatation/systolic dysfunction, or normal left ventricular diameters/ systolic function with evidence of ventricular scar on contrast enhanced-cardiac magnetic resonance or electroanatomic map.
- Sustained monomorphic ventricular tachycardia documented by 12-lead ECG or implantable cardioverter defibrillator (electrograms resistant to antiarrhythmic drug treatment or requiring implantable cardioverter defibrillator therapies.
Who cannot join
- • Patients with ventricular arrhythmias attributed to reversible causes.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims at comparing the recurrence rates of ventricular tachycardia ablated after being mapped by 2 different techniques.
Read the detailed description
The study participants are patients presented with recurrent ventricular tachycardia.
They will be divided into 2 groups in terms of mapping. The first group will use mapping during sinus rhythm to identify late potentials that may be incriminated in the tachycardia circuit.
The other group will undergo mapping during right ventricular extrastimulus pacing to unmask hidden potentials. The identified potentials will be ablated in both groups.
- Conditions
- Tachycardia, Ventricular
- Being tested
- Radiofrequency ablation
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablationProcedure or surgery
Both groups will undergo radiofrequency ablation of potentials likely responsible for the tachycardia. Those potentials are identified by the formentioned 2 distinct methods.
| Study group | Role | What they receive |
|---|---|---|
| Sinus Rhythm | Active comparator | This group will undergo mapping during sinus rhythm to identify and ablate late potentials that may be incriminated in the tachycardia circuit. Receives: Procedure: Radiofrequency ablation |
| Right ventricular extrastimulus pacing group | Active comparator | This group will undergo mapping during right ventricular single extrastimulus pacing to identify and thus ablate potentials that might have been masked during sinus rhythm. Receives: Procedure: Radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Recurrence of Ventricular Tachycardia
Recurrence of ventricular tachycardia implies receiving at least one appropriate implantable cardioverter defibrillator therapy or hospital admission due to symptomatic ventricular tachycardia.
Measured: 12 months
Secondary outcomes (2)
Number of Participants Who Experience Cardiac Death
This is defined as unexpected death where a cardiac cause is the most probable etiology
Measured: 12 months
Number of Participants Who Die From Any Cause (All-cause Mortality)
This includes death from any cause
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 posted21 Oct 2021
- Study start28 Oct 2021
- Primary completion26 Jun 2023
- Study completion26 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tachycardia, VentricularStudies 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
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Gamal, Ain Shams University
- Investigators
- Mohammad G Elewa, Principal investigator, AinShams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05086510
- Sponsor's protocol ID
- FMASUMD83/2021
- Status last verified
- Jul 2023
- First submitted
- 28 Sep 2021
- Last updated
- 20 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Elewa MG, Altoukhy S, Badran HA, El Damanhoury H, Zarif JK. Ablation targets of scar-related ventricular tachycardia identified by dynamic functional substrate mapping. Egypt Heart J. 2023 Oct 13;75(1):87. doi: 10.1186/s43044-023-00414-w.
PubMed 37831212
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ablation Targets of Scar-related Ventricular Tachycardia Identified by Dynamic Functional Substrate Mapping
- ClinicalTrials.gov ID
- NCT05086510
- Acronym / sponsor ID
- FMASUMD83/2021
- Conditions
- Tachycardia, Ventricular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 28 Oct 2021 (actual)
- Primary completion
- 26 Jun 2023 (actual)
- Study completion
- 26 Jun 2023 (actual)
- First posted
- 21 Oct 2021 (actual)
- Results
- Posted 20 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims at comparing the recurrence rates of ventricular tachycardia ablated after being mapped by 2 different techniques.
Detailed description
The study participants are patients presented with recurrent ventricular tachycardia.
They will be divided into 2 groups in terms of mapping. The first group will use mapping during sinus rhythm to identify late potentials that may be incriminated in the tachycardia circuit.
The other group will undergo mapping during right ventricular extrastimulus pacing to unmask hidden potentials. The identified potentials will be ablated in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sinus Rhythm | Active comparator | Procedure: Radiofrequency ablationThis group will undergo mapping during sinus rhythm to identify and ablate late potentials that may be incriminated in the tachycardia circuit. |
| Right ventricular extrastimulus pacing group | Active comparator | Procedure: Radiofrequency ablationThis group will undergo mapping during right ventricular single extrastimulus pacing to identify and thus ablate potentials that might have been masked during sinus rhythm. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- • Patients with structural heart disease; previous myocardial infarction, left ventricular dilatation/systolic dysfunction, or normal left ventricular diameters/ systolic function with evidence of ventricular scar on contrast enhanced-cardiac magnetic resonance or electroanatomic map.
Key exclusion criteria (1 listed)
- • Patients with ventricular arrhythmias attributed to reversible causes.
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 ablationBoth groups will undergo radiofrequency ablation of potentials likely responsible for the tachycardia. Those potentials are identified by the formentioned 2 distinct methods. | Procedure or surgery | Right ventricular extrastimulus pacing group, Sinus Rhythm |
Primary outcome
Number of Participants With Recurrence of Ventricular Tachycardia
Time frame: 12 months
Recurrence of ventricular tachycardia implies receiving at least one appropriate implantable cardioverter defibrillator therapy or hospital admission due to symptomatic ventricular tachycardia.
2 secondary outcomes
Number of Participants Who Experience Cardiac Death
Time frame: 12 months
Number of Participants Who Die From Any Cause (All-cause Mortality)
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37831212Elewa MG, Altoukhy S, Badran HA, El Damanhoury H, Zarif JK. Ablation targets of scar-related ventricular tachycardia identified by dynamic functional substrate mapping. Egypt Heart J. 2023 Oct 13;75(1):87. doi: 10.1186/s43044-023-00414-w.
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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.
Mohammad G Elewa principal investigator
AinShams university
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 ablation in people with Tachycardia, Ventricular, 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 2 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: finished, as of the sponsor's last update on 20 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?
Yes. Results are posted in the registry (first posted 20 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Recurrence of Ventricular Tachycardia (time frame: 12 months). 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 NCT05086510, 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 20 Feb 2024.