Trial Outcomes & Findings for 'Effect of CRT on Defibrillation Threshold Estimates' Study (NCT NCT00626093)

NCT ID: NCT00626093

Last Updated: 2019-02-05

Results Overview

All patients underwent defibrillation threshold testing at cardiac resynchronization therapy-defibrillator (CRT-D) implant and then at 6 months. The outcome measure is the difference in DFT (defibrillation threshold) in volts between implant and 6 months.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 77 participants
• Primary outcome timeframe: Baseline and 6 months
• Results posted on: 2019-02-05

Participant Flow

Participant milestones

Measure	Cardiac Resynchronization Therapy - Defibrillators (CRT-D) All patients enrolled were indicated for a CRT-D.
Overall Study STARTED	77
Overall Study COMPLETED	54
Overall Study NOT COMPLETED	23

Reasons for withdrawal

Measure	Cardiac Resynchronization Therapy - Defibrillators (CRT-D) All patients enrolled were indicated for a CRT-D.
Overall Study Lost to Follow-up	5
Overall Study Death	1
Overall Study Physician Decision	4
Overall Study Withdrawal by Subject	6
Overall Study Protocol Violation	1
Overall Study One of the required devices not implante	6

Baseline Characteristics

'Effect of CRT on Defibrillation Threshold Estimates' Study

Baseline characteristics by cohort

Measure	Group 1 n=77 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=93 Participants
Age, Categorical >=65 years	52 Participants n=93 Participants
Age, Continuous	69.9 years STANDARD_DEVIATION 11.2 • n=93 Participants
Sex: Female, Male Female	23 Participants n=93 Participants
Sex: Female, Male Male	54 Participants n=93 Participants
Region of Enrollment United States	77 participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

All patients underwent defibrillation threshold testing at cardiac resynchronization therapy-defibrillator (CRT-D) implant and then at 6 months. The outcome measure is the difference in DFT (defibrillation threshold) in volts between implant and 6 months.

Outcome measures

Measure	CRT-D n=77 Participants
Defibrillation Threshold Difference Obtained in Volts (V) Between Implant and 6 Months	5.6 Volts Standard Deviation 110.5

SECONDARY outcome

Timeframe: Baseline and 6 months

Outcome measures

Measure	CRT-D n=77 Participants
Defibrillation Threshold Difference Obtained in Joules (J)	0.3 Joules Standard Deviation 5

Adverse Events

Group 1

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group 1 n=77 participants at risk
General disorders Death	1.3% 1/77 • Number of events 1

Other adverse events

Measure	Group 1 n=77 participants at risk
Cardiac disorders Phrenic Nerve Stimulation	5.2% 4/77 • Number of events 4

Additional Information

Ashish Oza

St. Jude Medical

Phone: 818-493-3648

Email: aoza@sjm.com

Results disclosure agreements

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