NCT05086510

Brief Summary

This study aims at comparing the recurrence rates of ventricular tachycardia ablated after being mapped by 2 different techniques.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 21, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

October 28, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2023

Completed
8 months until next milestone

Results Posted

Study results publicly available

February 20, 2024

Completed
Last Updated

February 20, 2024

Status Verified

July 1, 2023

Enrollment Period

1.7 years

First QC Date

September 28, 2021

Results QC Date

July 3, 2023

Last Update Submit

July 3, 2023

Conditions

Tachycardia, Ventricular

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Number of Participants Who Experience Cardiac Death

    12 months

  • Number of Participants Who Die From Any Cause (All-cause Mortality)

    12 months

Study Arms (2)

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.

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.

Procedure: Radiofrequency ablation

Interventions

Radiofrequency ablationPROCEDURE

Both groups will undergo radiofrequency ablation of potentials likely responsible for the tachycardia. Those potentials are identified by the formentioned 2 distinct methods.

Right ventricular extrastimulus pacing groupSinus Rhythm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with ventricular arrhythmias attributed to reversible causes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AinShams university hospitals

Cairo, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 37831212DERIVED

MeSH Terms

Conditions

Tachycardia, Ventricular

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Results Point of Contact

Title
Dr. Mohammad Gamal
Organization
AinShamsU
mdgamal92@gmail.com
2001114115331

Study Officials

  • Mohammad G Elewa

    AinShams university

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 28, 2021

First Posted

October 21, 2021

Study Start

October 28, 2021

Primary Completion

June 26, 2023

Study Completion

June 26, 2023

Last Updated

February 20, 2024

Results First Posted

February 20, 2024

Record last verified: 2023-07

Locations

EG(1)