Trial Outcomes & Findings for Ablation at Virtual-hEart pRedicted Targets for VT (NCT NCT03536052)

NCT ID: NCT03536052

Last Updated: 2026-02-05

Results Overview

Following ablation, inducibility of VT will be determined using programmed electrical stimulation

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

time of procedure

Results posted on

2026-02-05

Participant Flow

Participant milestones

Participant milestones
Measure
Virtual Heart Guided Ablation
Virtual Heart Guided Ablation: If a good quality cardiac MRI is obtained and a virtual heart model with the ablation targets is generated, the operating physician will merge the virtual heart lesion map to the invasive electroanatomical navigation system. After the patient has been catheterized, an attempt should be made to induce VT. The physician should then navigate the catheter to each of the ablation targets specified, and place a lesion as per his or her training and experience, confirming when done that the lesion marker in the mapping system coincides with the target. This will be done for each lesion.
Overall Study
STARTED
10
Overall Study
COMPLETED
10
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ablation at Virtual-hEart pRedicted Targets for VT

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Virtual Heart Guided Ablation
n=10 Participants
Participants undergoing Virtual Heart Guided Ablation
Age, Continuous
70.9 years
STANDARD_DEVIATION 7.4 • n=41 Participants
Sex: Female, Male
Female
2 Participants
n=41 Participants
Sex: Female, Male
Male
8 Participants
n=41 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=41 Participants
Race (NIH/OMB)
Asian
0 Participants
n=41 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=41 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=41 Participants
Race (NIH/OMB)
White
10 Participants
n=41 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=41 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=41 Participants

PRIMARY outcome

Timeframe: time of procedure

Population: 3 participatnts were not included in the primary analysis. 2 participants were not inducible for ventricular tachycardia at the beginning of the procedure. 1 participant was not hemodynamically stable to attempt re induction of ventricular tachycardia

Following ablation, inducibility of VT will be determined using programmed electrical stimulation

Outcome measures

Outcome measures
Measure
Virtual Heart Guided Ablation
n=7 Participants
Participants undergoing virtual heart-guided ablation
Number of Participants With Ventricular Tachycardia Inducibility
6 Participants

SECONDARY outcome

Timeframe: 1 year

Long term Freedom of Spontaneous Ventricular Tachycardia

Outcome measures

Outcome measures
Measure
Virtual Heart Guided Ablation
n=10 Participants
Participants undergoing virtual heart-guided ablation
Freedom From Ventricular Tachycardia
2 Participants

Adverse Events

Virtual Heart Guided Ablation

Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jonathan Chrispin

Johns Hopkins University

Phone: 5169848124

Results disclosure agreements

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