Tachycardia, Ventricular
Conditions
Brief summary
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.
Interventions
PROCEDURERadiofrequency ablation
Both groups will undergo radiofrequency ablation of potentials likely responsible for the tachycardia. Those potentials are identified by the formentioned 2 distinct methods.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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. * 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.
Exclusion criteria
* • Patients with ventricular arrhythmias attributed to reversible causes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Recurrence of Ventricular Tachycardia | 12 months | Recurrence of ventricular tachycardia implies receiving at least one appropriate implantable cardioverter defibrillator therapy or hospital admission due to symptomatic ventricular tachycardia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experience Cardiac Death | 12 months | This is defined as unexpected death where a cardiac cause is the most probable etiology |
| Number of Participants Who Die From Any Cause (All-cause Mortality) | 12 months | This includes death from any cause |
Countries
Egypt
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 2 |
| Overall Study | Lost to Follow-up | 0 | 2 |
Baseline characteristics
| Characteristic | Non-DEEP Group | DEEP Group | Total |
|---|---|---|---|
| Age, Continuous | 53.75 years STANDARD_DEVIATION 11.85 | 55.65 years STANDARD_DEVIATION 15.87 | 54.7 years STANDARD_DEVIATION 13.85 |
| Number of ablation points | 81 ablation points | 30 ablation points | 47 ablation points |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Male | 19 Participants | 17 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 20 | 4 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 3 / 20 | 3 / 20 |
Outcome results
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.
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Non-DEEP Group | Number of Participants With Recurrence of Ventricular Tachycardia | 13 Participants |
| DEEP Group | Number of Participants With Recurrence of Ventricular Tachycardia | 13 Participants |
Secondary
Number of Participants Who Die From Any Cause (All-cause Mortality)
This includes death from any cause
Time frame: 12 months
Population: The number of participants who die from any cause
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Non-DEEP Group | Number of Participants Who Die From Any Cause (All-cause Mortality) | 5 Participants |
| DEEP Group | Number of Participants Who Die From Any Cause (All-cause Mortality) | 4 Participants |
Secondary
Number of Participants Who Experience Cardiac Death
This is defined as unexpected death where a cardiac cause is the most probable etiology
Time frame: 12 months
Population: The number of patients who experience cardiovascular mortality after a median follow up duration of 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Non-DEEP Group | Number of Participants Who Experience Cardiac Death | 5 Participants |
| DEEP Group | Number of Participants Who Experience Cardiac Death | 4 Participants |