Trial Outcomes & Findings for Low Energy Therapy to Convert Ventricular Tachycardias (NCT NCT02891863)

Results Overview

All system and procedure-related adverse events through 7 days (-1/+3 days) post-procedure will be collected and tracked.

Recruitment status

TERMINATED

Study phase

EARLY_PHASE1

Target enrollment

9 participants

Primary outcome timeframe

7 days post-procedure

Results posted on

2017-07-17

Participant Flow

Participant milestones

Participant milestones
Measure	Acute Testing Single-arm study - all subjects who meet the I\&E criteria, sign the consent form and have inducible VT within the protocol-specified criteria may be tested for VT conversion with the LEVER Acute Study System. LEVER Acute Study System: The LEVER Acute Study System is an acute pacing and shock delivery system intended for investigational use only. The LEVER Acute Study System is intended for acute conversion testing of monomorphic ventricular tachycardia by one of three different VT conversion methods.
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Low Energy Therapy to Convert Ventricular Tachycardias

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acute Testing n=9 Participants Single-arm study - all subjects who meet the I\&E criteria, sign the consent form and have inducible VT within the protocol-specified criteria may be tested for VT conversion with the LEVER Acute Study System. LEVER Acute Study System: The LEVER Acute Study System is an acute pacing and shock delivery system intended for investigational use only. The LEVER Acute Study System is intended for acute conversion testing of monomorphic ventricular tachycardia by one of three different VT conversion methods.
Age, Continuous	57 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: 7 days post-procedure

All system and procedure-related adverse events through 7 days (-1/+3 days) post-procedure will be collected and tracked.

Outcome measures

Outcome measures
Measure	Acute Testing n=9 Participants Single-arm study - all subjects who meet the I\&E criteria, sign the consent form and have inducible VT within the protocol-specified criteria may be tested for VT conversion with the LEVER Acute Study System. LEVER Acute Study System: The LEVER Acute Study System is an acute pacing and shock delivery system intended for investigational use only. The LEVER Acute Study System is intended for acute conversion testing of monomorphic ventricular tachycardia by one of three different VT conversion methods.
System and Procedure Related Adverse Events	5 participants

PRIMARY outcome

Timeframe: Acute - eg within 5 seconds of test therapy delivery

Population: 6 of 9 subjects had at least one inducible VT, a total of 14 attempts to convert VT with multiple pulses were delivered and none converted the VT in any subject.

Effectiveness of LEVER Acute Study System low energy therapies to convert MVTs will be collected and tracked as an aggregate success rate (%) on a per-attempt basis for each therapy tested.

Outcome measures

Outcome measures
Measure	Acute Testing n=14 Attempts at VF Conversion Single-arm study - all subjects who meet the I\&E criteria, sign the consent form and have inducible VT within the protocol-specified criteria may be tested for VT conversion with the LEVER Acute Study System. LEVER Acute Study System: The LEVER Acute Study System is an acute pacing and shock delivery system intended for investigational use only. The LEVER Acute Study System is intended for acute conversion testing of monomorphic ventricular tachycardia by one of three different VT conversion methods.
Conversion Efficacy of Low Energy VT Therapies	0 percentage of VF conversion success

Adverse Events

Acute Testing

Serious events: 3 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Acute Testing n=9 participants at risk Single-arm study - all subjects who meet the I\&E criteria, sign the consent form and have inducible VT within the protocol-specified criteria may be tested for VT conversion with the LEVER Acute Study System. LEVER Acute Study System: The LEVER Acute Study System is an acute pacing and shock delivery system intended for investigational use only. The LEVER Acute Study System is intended for acute conversion testing of monomorphic ventricular tachycardia by one of three different VT conversion methods.
Cardiac disorders post-procedure VT recurred	11.1% 1/9 • Number of events 1 • from the time of the acute testing until 7 days post-procedure
Cardiac disorders VT accelerated to VF	11.1% 1/9 • Number of events 1 • from the time of the acute testing until 7 days post-procedure
Cardiac disorders LV impairment	11.1% 1/9 • Number of events 1 • from the time of the acute testing until 7 days post-procedure

Other adverse events

Other adverse events
Measure	Acute Testing n=9 participants at risk Single-arm study - all subjects who meet the I\&E criteria, sign the consent form and have inducible VT within the protocol-specified criteria may be tested for VT conversion with the LEVER Acute Study System. LEVER Acute Study System: The LEVER Acute Study System is an acute pacing and shock delivery system intended for investigational use only. The LEVER Acute Study System is intended for acute conversion testing of monomorphic ventricular tachycardia by one of three different VT conversion methods.
Musculoskeletal and connective tissue disorders muscle soreness	11.1% 1/9 • Number of events 1 • from the time of the acute testing until 7 days post-procedure
Cardiac disorders VT acceleration to VF	11.1% 1/9 • Number of events 1 • from the time of the acute testing until 7 days post-procedure

Additional Information

Greg Voss

Boston Scientific CRM

Phone: 651-581-3068

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee This an early-stage feasibility study with significant intellectual property value to the sponsor. The sponsor controls access to the data and no publications can be submitted without the sponsors approval. Since the study was stopped early due to futility it may not be publishable, but preliminary data was submitted via abstract for presentation at Heart Rhythm 2017.
Publication restrictions are in place

Restriction type: OTHER