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This study aims at comparing the recurrence rates of ventricular tachycardia ablated after being mapped by 2 different techniques.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency ablation | Procedure | Both groups will undergo radiofrequency ablation of potentials likely responsible for the tachycardia. Those potentials are identified by the formentioned 2 distinct methods. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience Cardiac Death | This is defined as unexpected death where a cardiac cause is the most probable etiology | 12 months |
| Number of Participants Who Die From Any Cause (All-cause Mortality) |
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Inclusion Criteria:
• 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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohammad G Elewa | AinShams university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AinShams university hospitals | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37831212 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-DEEP Group | This group will undergo mapping during sinus rhythm to identify and ablate late potentials that may be incriminated in the tachycardia circuit. Radiofrequency ablation: Both groups will undergo radiofrequency ablation of potentials likely responsible for the tachycardia. Those potentials are identified by the formentioned 2 distinct methods. |
| FG001 | DEEP Group | 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. Radiofrequency ablation: Both groups will undergo radiofrequency ablation of potentials likely responsible for the tachycardia. Those potentials are identified by the formentioned 2 distinct methods. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-DEEP Group | This group will undergo mapping during sinus rhythm to identify and ablate late potentials that may be incriminated in the tachycardia circuit. Radiofrequency ablation: Both groups will undergo radiofrequency ablation of potentials likely responsible for the tachycardia. Those potentials are identified by the formentioned 2 distinct methods. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Among the patients who completed the study, the number of patients who experienced recurrence of ventricular tachycardia after a median follow up duration of 12 months is reported. | Posted | Count of Participants | Participants | 12 months |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Non-DEEP Group | This group will undergo mapping during sinus rhythm to identify and ablate late potentials that may be incriminated in the tachycardia circuit. Radiofrequency ablation: Both groups will undergo radiofrequency ablation of potentials likely responsible for the tachycardia. Those potentials are identified by the formentioned 2 distinct methods. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac tamponade | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mohammad Gamal | AinShamsU | 2001114115331 | mdgamal92@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 28, 2021 | Jul 3, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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This includes death from any cause
| 12 months |
| BG001 |
| DEEP Group |
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. Radiofrequency ablation: Both groups will undergo radiofrequency ablation of potentials likely responsible for the tachycardia. Those potentials are identified by the formentioned 2 distinct methods. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Number of ablation points | Median | Inter-Quartile Range | ablation points |
|
| OG001 | DEEP Group | 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. Radiofrequency ablation: Both groups will undergo radiofrequency ablation of potentials likely responsible for the tachycardia. Those potentials are identified by the formentioned 2 distinct methods. |
|
|
| Secondary | Number of Participants Who Experience Cardiac Death | This is defined as unexpected death where a cardiac cause is the most probable etiology | The number of patients who experience cardiovascular mortality after a median follow up duration of 12 months | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Number of Participants Who Die From Any Cause (All-cause Mortality) | This includes death from any cause | The number of participants who die from any cause | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 5 |
| 20 |
| 3 |
| 20 |
| 0 |
| 20 |
| EG001 | DEEP Group | 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. Radiofrequency ablation: Both groups will undergo radiofrequency ablation of potentials likely responsible for the tachycardia. Those potentials are identified by the formentioned 2 distinct methods. | 4 | 20 | 3 | 20 | 0 | 20 |
| Ventricular fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| heart block | Cardiac disorders | Non-systematic Assessment |
|
| pulmonary edema | Cardiac disorders | Non-systematic Assessment |
|
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| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |