Ablation Targets of Scar-related Ventricular Tachycardia Identified by Dynamic Functional Substrate Mapping

Sponsor
Ain Shams University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05086510
Collaborator
(none)
40
1
2
21.1
1.9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Radiofrequency ablation
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Ablation Targets of Scar-related Ventricular Tachycardia Identified by Dynamic Functional Substrate Mapping
Anticipated Study Start Date :
Oct 28, 2021
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Sinus Rhythm

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

Active Comparator: Sense protocol 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.

Procedure: 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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. Number of participants receiving at least one appropriate implantable cardioverter defibrillator therapy [12 months]

    Appropriate therapies include anti tachycardia pacing and shocks

  3. Time to first recurrence of ventricular tachycardia [12 months]

    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

  1. Number of participants who experience sudden cardiac death [12 months]

    This is defined as unexpected death where a cardiac cause is the most probable etiology

  2. Number of participants who die from any cause (All-cause mortality) [12 months]

    This includes death from any cause

  3. Number of hospitalizations for heart failure per participant [12 months]

    This denotes hospital admission due to new or worsening symptoms of heart failure

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 AinShams university hospitals Cairo Egypt

Sponsors and Collaborators

  • Ain Shams University

Investigators

  • Principal Investigator: Mohammad G Elewa, AinShams university

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohammad Gamal, Principal investigator, Ain Shams University
ClinicalTrials.gov Identifier:
NCT05086510
Other Study ID Numbers:
  • FMASUMD83/2021
First Posted:
Oct 21, 2021
Last Update Posted:
Oct 26, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 26, 2021