Trial Outcomes & Findings for Ablation Targets of Scar-related Ventricular Tachycardia Identified by Dynamic Functional Substrate Mapping (NCT NCT05086510)

NCT ID: NCT05086510

Last Updated: 2024-02-20

Results Overview

Recurrence of ventricular tachycardia implies receiving at least one appropriate implantable cardioverter defibrillator therapy or hospital admission due to symptomatic ventricular tachycardia.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2024-02-20

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	20	20
Overall Study COMPLETED	20	16
Overall Study NOT COMPLETED	0	4

Reasons for withdrawal

Measure	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.	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.
Overall Study Lost to Follow-up	0	2
Overall Study Death	0	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Non-DEEP Group n=20 Participants 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.	DEEP Group n=20 Participants 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.	Total n=40 Participants Total of all reporting groups
Age, Continuous	53.75 years STANDARD_DEVIATION 11.85 • n=20 Participants	55.65 years STANDARD_DEVIATION 15.87 • n=20 Participants	54.7 years STANDARD_DEVIATION 13.85 • n=40 Participants
Sex: Female, Male Female	1 Participants n=20 Participants	3 Participants n=20 Participants	4 Participants n=40 Participants
Sex: Female, Male Male	19 Participants n=20 Participants	17 Participants n=20 Participants	36 Participants n=40 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Number of ablation points	81 ablation points n=20 Participants	30 ablation points n=20 Participants	47 ablation points n=40 Participants

PRIMARY outcome

Timeframe: 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.

Recurrence of ventricular tachycardia implies receiving at least one appropriate implantable cardioverter defibrillator therapy or hospital admission due to symptomatic ventricular tachycardia.

Outcome measures

Measure	Non-DEEP Group n=20 Participants 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.	DEEP Group n=20 Participants 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.
Number of Participants With Recurrence of Ventricular Tachycardia	13 Participants	13 Participants

SECONDARY outcome

Timeframe: 12 months

Population: The number of patients who experience cardiovascular mortality after a median follow up duration of 12 months

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

Outcome measures

Measure	Non-DEEP Group n=20 Participants 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.	DEEP Group n=20 Participants 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.
Number of Participants Who Experience Cardiac Death	5 Participants	4 Participants

SECONDARY outcome

Timeframe: 12 months

Population: The number of participants who die from any cause

This includes death from any cause

Outcome measures

Measure	Non-DEEP Group n=20 Participants 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.	DEEP Group n=20 Participants 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.
Number of Participants Who Die From Any Cause (All-cause Mortality)	5 Participants	4 Participants

Adverse Events

Non-DEEP Group

Serious events: 3 serious events

Other events: 0 other events

Deaths: 5 deaths

DEEP Group

Serious events: 3 serious events

Other events: 0 other events

Deaths: 4 deaths

Serious adverse events

Measure	Non-DEEP Group n=20 participants at risk 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.	DEEP Group n=20 participants at risk 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.
Cardiac disorders Cardiac tamponade	0.00% 0/20 • 12 months	15.0% 3/20 • 12 months
Cardiac disorders Ventricular fibrillation	5.0% 1/20 • 12 months	0.00% 0/20 • 12 months
Cardiac disorders heart block	5.0% 1/20 • 12 months	0.00% 0/20 • 12 months
Cardiac disorders pulmonary edema	5.0% 1/20 • 12 months	0.00% 0/20 • 12 months

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mohammad Gamal

AinShamsU

Phone: 2001114115331

Email: mdgamal92@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place