Back to resultsAblation Targets of Scar-related Ventricular Tachycardia Identified by Dynamic Functional Substrate Mapping
Primary Purpose
Tachycardia, Ventricular
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Radiofrequency ablation
Sponsored by
About this trial
This is an interventional treatment trial for Tachycardia, Ventricular
Eligibility Criteria
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.
Sites / Locations
- AinShams university hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Sinus Rhythm
Right ventricular extrastimulus pacing group
Arm Description
This group will undergo mapping during sinus rhythm to identify and ablate late potentials that may be incriminated in the tachycardia circuit.
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.
Outcomes
Primary Outcome Measures
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.
Number of participants receiving at least one appropriate implantable cardioverter defibrillator therapy
Appropriate therapies include anti tachycardia pacing and shocks
Time to first recurrence of ventricular tachycardia
This will be measured from the end of the ablation procedure till the first documented recurrence of ventricular tachycardia whether by electrocardiogram or by device tracings
Secondary Outcome Measures
Number of participants who experience sudden cardiac death
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)
This includes death from any cause
Number of hospitalizations for heart failure per participant
This denotes hospital admission due to new or worsening symptoms of heart failure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05086510
Brief Title
Ablation Targets of Scar-related Ventricular Tachycardia Identified by Dynamic Functional Substrate Mapping
Official Title
Ablation Targets of Scar-related Ventricular Tachycardia Identified by Dynamic Functional Substrate Mapping
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 28, 2021 (Actual)
Primary Completion Date
June 26, 2023 (Actual)
Study Completion Date
June 26, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tachycardia, Ventricular
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sinus Rhythm
Arm Type
Active Comparator
Arm Description
This group will undergo mapping during sinus rhythm to identify and ablate late potentials that may be incriminated in the tachycardia circuit.
Arm Title
Right ventricular extrastimulus pacing group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency ablation
Intervention Description
Both groups will undergo radiofrequency ablation of potentials likely responsible for the tachycardia. Those potentials are identified by the formentioned 2 distinct methods.
Primary Outcome Measure Information:
Title
Number of participants with recurrence of ventricular tachycardia
Description
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
Title
Number of participants receiving at least one appropriate implantable cardioverter defibrillator therapy
Description
Appropriate therapies include anti tachycardia pacing and shocks
Time Frame
12 months
Title
Time to first recurrence of ventricular tachycardia
Description
This will be measured from the end of the ablation procedure till the first documented recurrence of ventricular tachycardia whether by electrocardiogram or by device tracings
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of participants who experience sudden cardiac death
Description
This is defined as unexpected death where a cardiac cause is the most probable etiology
Time Frame
12 months
Title
Number of participants who die from any cause (All-cause mortality)
Description
This includes death from any cause
Time Frame
12 months
Title
Number of hospitalizations for heart failure per participant
Description
This denotes hospital admission due to new or worsening symptoms of heart failure
Time Frame
12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad G Elewa
Organizational Affiliation
AinShams university
Official's Role
Principal Investigator
Facility Information:
Facility Name
AinShams university hospitals
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Ablation Targets of Scar-related Ventricular Tachycardia Identified by Dynamic Functional Substrate Mapping
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