Trial Outcomes & Findings for Multimodality Assessment of Ventricular Scar Arrhythmogenicity. (NCT NCT04632394)

NCT ID: NCT04632394

Last Updated: 2025-05-30

Results Overview

Duration of electrograms at digital twin predicted sites compared to non-predicted sites on invasive mapping within areas of bipolar low voltage (\<1.5mV)

• Recruitment status: COMPLETED
• Target enrollment: 18 participants
• Primary outcome timeframe: During ablation
• Results posted on: 2025-05-30

Participant Flow

Participant milestones

Measure	Cases Patients with scar-dependent ventricular tachycardia, requiring ablation. These patients will have satisfied the inclusion/exclusion criteria and be put forward for VT ablation. They will undergo the previously described study protocol, including generation of a computational model of the heart from their cardiac MRI and a VT ablation where we will study the points of interest generated from the MRI model in detail. Generation of computational model from cardiac MRI.: Routine cardiac MRI scan results will be sent to Johns Hopkins University where a computer-generated model of the heart will be made, which will demonstrate predicted areas critical to VT generation and maintenance. This data will be sent back to St George's, and integrated with the standard VT ablation mapping software to allow comparison of its accuracy with standard mapping techniques. VT ablation: Routine VT ablation as described elsewhere in the literature. However, a brief period of extra time (\~30 minutes) will be spent analysing the areas of the heart which the MRI scan predicted as being important for generation of VT. We will study the effect of ablation of these areas (if indicated) on distant parts of the heart.
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Multimodality Assessment of Ventricular Scar Arrhythmogenicity.

Baseline characteristics by cohort

Measure	Cohort n=18 Participants Cohort of patients who underwent digital twin generation and VT ablation.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants
Age, Continuous	68.4 Years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United Kingdom	18 participants n=5 Participants

PRIMARY outcome

Timeframe: During ablation

Duration of electrograms at digital twin predicted sites compared to non-predicted sites on invasive mapping within areas of bipolar low voltage (<1.5mV)

Outcome measures

Measure	Predicted Sites n=18 Participants Digital twin sites predicted to harbour VT	Non-predicted Sites n=18 Participants Sites not suggestive of critical importance by the digital twin
Electrogram Duration at Digital Twin Predicted Sites Compared to Non-predicted Sites	77.5 ms Standard Deviation 25.8	65.7 ms Standard Deviation 40.0

SECONDARY outcome

Timeframe: 12 months

Population: Recurrence of ventricular arrhythmia at 1 year

Assessment of patient's symptoms at a clinical consultation following the ablation.

Outcome measures

Measure	Predicted Sites n=18 Participants Digital twin sites predicted to harbour VT	Non-predicted Sites Sites not suggestive of critical importance by the digital twin
Symptom Assessment at 12 Month Clinical Follow up	2 Participants	—

Adverse Events

Cases

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Measure

Cases n=18 participants at risk Patients with scar-dependent ventricular tachycardia, requiring ablation. These patients will have satisfied the inclusion/exclusion criteria and be put forward for VT ablation. They will undergo the previously described study protocol, including generation of a computational model of the heart from their cardiac MRI and a VT ablation where we will study the points of interest generated from the MRI model in detail. Generation of computational model from cardiac MRI.: Routine cardiac MRI scan results will be sent to Johns Hopkins University where a computer-generated model of the heart will be made, which will demonstrate predicted areas critical to VT generation and maintenance. This data will be sent back to St George's, and integrated with the standard VT ablation mapping software to allow comparison of its accuracy with standard mapping techniques. VT ablation: Routine VT ablation as described elsewhere in the literature. However, a brief period of extra time (\~30 minutes) will be spent analysing the areas of the heart which the MRI scan predicted as being important for generation of VT. We will study the effect of ablation of these areas (if indicated) on distant parts of the heart.

Cardiac disorders Ventricular septal defect

5.6% 1/18 • Number of events 1 • 1 year

Other adverse events

Adverse event data not reported

Additional Information

Dr Michael Waight

St George's University of London

Phone: 020 8672 9944

Email: m2110065@citystgeorges.ac.uk

Results disclosure agreements

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