Trial Outcomes & Findings for Safety and Efficacy of Automatic Testing Feature in New ICDs and CRT-Ds (NCT NCT00746356)

NCT ID: NCT00746356

Last Updated: 2019-02-19

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

128 participants

Primary outcome timeframe

3 months post implant

Results posted on

2019-02-19

Participant Flow

Recruitment began in August 2008 at hospitals where patients were being implanted with implantable cardioverter defibrillators or in and physician offices where these patients were being followed. Recruitment was completed on April 1, 2009.

All patients who were enrolled in the study had the autocapture feature tested at each study visit, starting with at the implant visit when the study device was implanted.

Participant milestones

Participant milestones
Measure	CRT-D Device Patients All patients with a cardiac resynchronization therapy device (CRT-D)enrolled in the study.	ICD Device Patients All patients with an implantable cardioverter defibrillator (ICD) device enrolled in the study.
Overall Study STARTED	81	47
Overall Study COMPLETED	70	40
Overall Study NOT COMPLETED	11	7

Reasons for withdrawal

Reasons for withdrawal
Measure	CRT-D Device Patients All patients with a cardiac resynchronization therapy device (CRT-D)enrolled in the study.	ICD Device Patients All patients with an implantable cardioverter defibrillator (ICD) device enrolled in the study.
Overall Study Withdrawal by Subject	2	3
Overall Study Death	7	3
Overall Study Lost to Follow-up	1	0
Overall Study Removal of Device	0	1
Overall Study Patient relocated	1	0

Baseline Characteristics

Safety and Efficacy of Automatic Testing Feature in New ICDs and CRT-Ds

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Patients n=128 Participants All patients enrolled in the study
Age, Continuous	67 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants
Sex: Female, Male Male	96 Participants n=5 Participants
Cardiomyopathy Ischemic Etiology	87 Participants n=5 Participants
Cardiomyopathy Non-Ischemic Etiology	41 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months post implant

Outcome measures

Outcome measures
Measure	Participants Successfully Implanted With Devices n=128 Participants All participants successfully implanted with an ICD or CRT-D
Percentage of Participants Free of System-related Complications at 3-months Post Implant	93.6 Percentage of Participants Interval 89.9 to

PRIMARY outcome

Timeframe: 3 months post implant

Population: Per protocol, the first 19 participants who successfully completed both an automatic and manual capture threshold test were included in this analysis.

Atrial AutoCapture Confirm is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the atrial pacing voltage until it determines that the device is no longer capturing the atria. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the atrial pulse voltage and determines the atrial threshold by viewing the EKG.

Outcome measures

Outcome measures
Measure	Participants Successfully Implanted With Devices n=19 Participants All participants successfully implanted with an ICD or CRT-D
Atrial AutoCapture (ACap) Confirm Effectiveness Endpoint - Absolute Difference Between the Automatic and Manual Capture Threshold Test Atrial AutoCapture Threshold	0.743 Volts Standard Deviation 0.357
Atrial AutoCapture (ACap) Confirm Effectiveness Endpoint - Absolute Difference Between the Automatic and Manual Capture Threshold Test Manual Capture Threshold	0.737 Volts Standard Deviation 0.195

PRIMARY outcome

Timeframe: 3 months post implant

Population: Per protocol, the first 38 participants with an ICD who successfully completed both an automatic and manual capture threshold test were included in this analysis.

Ventricular AutoCapture is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the ventricular pacing voltage until it determines that the device is no longer capturing the ventricles. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the ventricular pulse voltage and determines the ventricular threshold by viewing the EKG.

Outcome measures

Outcome measures
Measure	Participants Successfully Implanted With Devices n=38 Participants All participants successfully implanted with an ICD or CRT-D
Ventricular Autocapture Effectiveness Endpoint - Absolute Difference Between the Automatic and Manual Capture Threshold Test Automatic Capture Threshold	0.809 Volts Standard Deviation 0.405
Ventricular Autocapture Effectiveness Endpoint - Absolute Difference Between the Automatic and Manual Capture Threshold Test Manual Capture Threshold	0.862 Volts Standard Deviation 0.442

PRIMARY outcome

Timeframe: 3 months post implant

Population: Per protocol, the first 43 CRT-D participants who successfully completed both an automatic and manual capture threshold in the right ventricle were included in this analysis.

Right Ventricular AutoCapture is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the ventricular pacing voltage until it determines that the device is no longer capturing the ventricles. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the ventricular pulse voltage and determines the ventricular threshold by viewing the EKG.

Outcome measures

Outcome measures
Measure	Participants Successfully Implanted With Devices n=43 Participants All participants successfully implanted with an ICD or CRT-D
Right Ventricular (RV) AutoCapture Effectiveness Endpoint - Difference Between the Automatic and Manual Capture Threshold Test Automatic Capture Threshold	0.739 Volts Standard Deviation 0.279
Right Ventricular (RV) AutoCapture Effectiveness Endpoint - Difference Between the Automatic and Manual Capture Threshold Test Manual Capture Threshold	0.794 Volts Standard Deviation 0.278

PRIMARY outcome

Timeframe: 3 months post implant

Population: Per protocol, the first 43 CRT-D participants who successfully completed both an automatic and manual threshold in the left ventricle were included in the analysis.

Left Ventricular AutoCapture is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the ventricular pacing voltage until it determines that the device is no longer capturing the ventricles. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the ventricular pulse voltage and determines the ventricular threshold by viewing the EKG.

Outcome measures

Outcome measures
Measure	Participants Successfully Implanted With Devices n=43 Participants All participants successfully implanted with an ICD or CRT-D
Left Ventricular (LV) AutoCapture Effectiveness Endpoint - Difference Between the Automatic and Manual Capture Threshold Test Automatic Capture Threshold	1.458 Volts Standard Deviation 0.631
Left Ventricular (LV) AutoCapture Effectiveness Endpoint - Difference Between the Automatic and Manual Capture Threshold Test Manual Capture Threshold	1.456 Volts Standard Deviation 0.618

Adverse Events

All Patients

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	All Patients n=128 participants at risk All patients enrolled in the study
Surgical and medical procedures ecchymosis at implant site	0.78% 1/128 • Number of events 1 • 9 months
Surgical and medical procedures hematoma	5.5% 7/128 • Number of events 7 • 9 months
Surgical and medical procedures LV lead dislodgement	0.78% 1/128 • Number of events 1 • 9 months
Surgical and medical procedures pericardial tamponade	0.78% 1/128 • Number of events 1 • 9 months
Surgical and medical procedures erroneous elective replacement alert	2.3% 3/128 • Number of events 3 • 9 months
Cardiac disorders high defibrillation thresholds	0.78% 1/128 • Number of events 1 • 9 months
Surgical and medical procedures infection	1.6% 2/128 • Number of events 2 • 9 months
Surgical and medical procedures suspected set screw malfunction	0.78% 1/128 • Number of events 1 • 9 months
Surgical and medical procedures suspected generator malfunction	0.78% 1/128 • Number of events 1 • 9 months
Cardiac disorders elevated pacing thresholds - RA lead	0.78% 1/128 • Number of events 1 • 9 months
Cardiac disorders elevated pacing thresholds - RV lead	1.6% 2/128 • Number of events 2 • 9 months
Cardiac disorders elevated pacing threshold - LV lead	7.0% 9/128 • Number of events 9 • 9 months
Surgical and medical procedures lead dislodgement/migration - RA lead	1.6% 2/128 • Number of events 2 • 9 months
Surgical and medical procedures lead dislodgement/migration - RV lead	0.78% 1/128 • Number of events 1 • 9 months
Surgical and medical procedures lead dislodgement/migration - LV lead	2.3% 3/128 • Number of events 4 • 9 months
Surgical and medical procedures lead insulation damage - RV lead	0.78% 1/128 • Number of events 1 • 9 months
Surgical and medical procedures phrenic nerve/diaphragmatic stimulation - LV lead	3.9% 5/128 • Number of events 5 • 9 months
Surgical and medical procedures RA and RV lead dislodgement/migration	0.78% 1/128 • Number of events 1 • 9 months

Additional Information

Ashish Oza, Clinical Studies Director

St. Jude Medical

Phone: 818 362 6822

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60