Trial Outcomes & Findings for Stepwise Approach To sUbstrate Modification for Ventricular Tachycardia (NCT NCT01546207)

Results Overview

The procedural efficacy as defined as acute success of a standardized step-wise approach for substrate-based catheter ablation of recurrent ventricular tachycardia in patients with coronary artery disease and prior ventricular tachycardia or appropriate therapy. Acute success will be defined as the ability to render VT non-inducible with a standardized complete stimulation protocol. catheter ablation - a medical procedure used to treat some types of arrhythmia

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

at time of catheter ablation procedure (intraoperative)

Results posted on

2020-01-13

Participant Flow

Patients were recruited from 12/2011 to 7/2013, at a medical clinic at MSSM.

Participant milestones

Participant milestones
Measure	Catheter-based Ablation catheter ablation - a medical procedure used to treat some types of arrhythmia
Overall Study STARTED	4
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Catheter-based Ablation catheter ablation - a medical procedure used to treat some types of arrhythmia
Overall Study Death	1

Baseline Characteristics

Stepwise Approach To sUbstrate Modification for Ventricular Tachycardia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Catheter-based Ablation n=4 Participants catheter ablation - a medical procedure used to treat some types of arrhythmia
Age, Continuous	61.75 years STANDARD_DEVIATION 7.18 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: at time of catheter ablation procedure (intraoperative)

Population: Given the small sample size, we did not analyze the data as there would be no statistical significance.

The procedural efficacy as defined as acute success of a standardized step-wise approach for substrate-based catheter ablation of recurrent ventricular tachycardia in patients with coronary artery disease and prior ventricular tachycardia or appropriate therapy. Acute success will be defined as the ability to render VT non-inducible with a standardized complete stimulation protocol. catheter ablation - a medical procedure used to treat some types of arrhythmia

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline and 6 months follow-up

Chronic success will be defined as no recurrence of sustained VT or VT resulting in ICD therapies (ATP and/or ICD shocks) at 6 months follow-up as compared to baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 week post-op

2\) Procedural safety as defined by the number of complication within 1week associated with the procedure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline and post-op day one after procedure

Relationship between change in pre/post saECG and success of the step-wise ablation strategy

Outcome measures

Outcome data not reported

Adverse Events

Catheter-based Ablation

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Catheter-based Ablation n=4 participants at risk catheter ablation - a medical procedure used to treat some types of arrhythmia
Cardiac disorders Ventricular Tachycardia	25.0% 1/4 • Number of events 4
Blood and lymphatic system disorders pseudoaneurysm with hematoma	25.0% 1/4 • Number of events 4

Other adverse events

Other adverse events
Measure	Catheter-based Ablation n=4 participants at risk catheter ablation - a medical procedure used to treat some types of arrhythmia
Renal and urinary disorders hematuria	25.0% 1/4 • Number of events 1
Cardiac disorders pericardial effusion	25.0% 1/4 • Number of events 1
Injury, poisoning and procedural complications fall	25.0% 1/4 • Number of events 1
Cardiac disorders sustained Ventricular Tachycardia	25.0% 1/4 • Number of events 1

Additional Information

Dr. Vivek Y. Reddy

Icahn School of Medicine at Mount Sinai

Phone: 212-241-7114

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place