Trial Outcomes & Findings for Attain Model 4196 Left Ventricular (LV) Lead (NCT NCT00271544)

Results Overview

A subject who was free of a Model 4196 lead related complication by one month visit.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

190 participants

Primary outcome timeframe

One Month

Results posted on

2009-09-28

Participant Flow

Total number of patients enrolled after meeting inclusion/exclusion criteria was 190. Total number of patients that received an implant attempt was 186. Total number of patients with a 4196 lead attempt was 177. Total number of patients successfully implanted with a 4196 lead was 170. Some data was not reported and deviations were recorded.

Participant milestones

Participant milestones
Measure	4196 Lead Subjects underwent Model 4196 left ventricular lead implant attempt
Overall Study STARTED	190
Overall Study Implant Attempted	186
Overall Study Model 4196 Lead Attempted	177
Overall Study COMPLETED	170
Overall Study NOT COMPLETED	20

Reasons for withdrawal

Reasons for withdrawal
Measure	4196 Lead Subjects underwent Model 4196 left ventricular lead implant attempt
Overall Study Subjects did not receive a 4196 lead	7
Overall Study Model 4196 lead not attempted	9
Overall Study Implant not attempted	4

Baseline Characteristics

Attain Model 4196 Left Ventricular (LV) Lead

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	4196 Lead n=186 Participants Subjects underwent Model 4196 left ventricular lead implant attempt
Region of Enrollment United States	143 participants n=5 Participants
Region of Enrollment Canada	43 participants n=5 Participants
Race / Ethnicity American Indian or Alaska Native	1 Participants n=5 Participants
New York Heart Association Class III	182 Participants n=5 Participants
New York Heart Association Class IV	2 Participants n=5 Participants
New York Heart Association Missing	2 Participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	57 Participants n=5 Participants
Age, Categorical >=65 years	129 Participants n=5 Participants
Age Continuous	69.1 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants
Sex: Female, Male Male	138 Participants n=5 Participants
Race / Ethnicity Asian	2 Participants n=5 Participants
Race / Ethnicity Black or African American	10 Participants n=5 Participants
Race / Ethnicity Columbian	1 Participants n=5 Participants
Race / Ethnicity Hispanic or Latino	3 Participants n=5 Participants
Race / Ethnicity Native Hawaiian or Pacific Islander	1 Participants n=5 Participants
Race / Ethnicity Sri Lankan	1 Participants n=5 Participants
Race / Ethnicity Subject chose not to provide	6 Participants n=5 Participants
Race / Ethnicity White	161 Participants n=5 Participants
Intrinsic QRS Width	153.1 Milliseconds STANDARD_DEVIATION 24.1 • n=5 Participants
Left Ventricular Ejection Fraction	24.2 Percent STANDARD_DEVIATION 6.9 • n=5 Participants

PRIMARY outcome

Timeframe: One Month

Population: Subjects who underwent a Model 4196 left ventricular (LV) lead implant attempt and completed 1-month visit; or experienced Model 4196 lead related complications by 1-month visit.

A subject who was free of a Model 4196 lead related complication by one month visit.

Outcome measures

Outcome measures
Measure	4196 Lead n=176 Participants Subjects who underwent Model 4196 left ventricular lead implant attempt
Safety (Subjects Without a Model 4196 Lead Related Complication)	168 participants Interval 92.0 to 100.0

PRIMARY outcome

Timeframe: One Month

Population: Subjects with pacing threshold at tip electrode captured at 0.5 milliseconds (ms) at 1-month visit.

Model 4196 lead distal tip electrode mean pacing voltage threshold (at 0.5 milliseconds \[ms\])

Outcome measures

Outcome measures
Measure	4196 Lead n=160 Participants Subjects who underwent Model 4196 left ventricular lead implant attempt
Efficacy (Pacing Voltage Thresholds of Distal Tip Electrode)	1.1 volts Standard Deviation 0.9

PRIMARY outcome

Timeframe: Three Months

Population: Subjects with pacing threshold at ring electrode captured at 0.5 milliseconds (ms) at 3-month visit.

Model 4196 lead proximal ring electrode mean pacing voltage threshold (at 0.5 milliseconds \[ms\])

Outcome measures

Outcome measures
Measure	4196 Lead n=135 Participants Subjects who underwent Model 4196 left ventricular lead implant attempt
Efficacy (Pacing Voltage Threshold of Proximal Ring Electrode)	1.9 volts Standard Deviation 2.0

SECONDARY outcome

Timeframe: Implant

Population: Subjects who underwent Model 4196 lead implant attempt.

A successful implant occurs when the Model 4196 lead is implanted in the left ventricle of the heart and functions appropriately.

Outcome measures

Outcome measures
Measure	4196 Lead n=177 Participants Subjects who underwent Model 4196 left ventricular lead implant attempt
Subjects Successfully Implanted With Model 4196 Lead	170 participants

SECONDARY outcome

Timeframe: Implant

Population: Subjects with successful CS cannulation after an incision was made (implant attempt)

A successful implant occurs when the coronary sinus (CS) is successfully cannulated and a left ventricular lead is implanted in the left ventricle of the heart and functions appropriately.

Outcome measures

Outcome measures
Measure	4196 Lead n=183 Participants Subjects who underwent Model 4196 left ventricular lead implant attempt
Subjects Successfully Implanted After Cannulation	181 participants

SECONDARY outcome

Timeframe: Implant

Population: Subjects who underwent an implant attempt.

All left ventricular leads successfully implanted

Outcome measures

Outcome measures
Measure	4196 Lead n=186 Participants Subjects who underwent Model 4196 left ventricular lead implant attempt
All Left Ventricular Leads	181 participants

SECONDARY outcome

Timeframe: Implant

Population: Subjects who underwent an implant attempt.

All Medtronic left ventricular leads (Lead Model Numbers included 4193, 4194, 4195 and 4196) successfully implanted

Outcome measures

Outcome measures
Measure	4196 Lead n=186 Participants Subjects who underwent Model 4196 left ventricular lead implant attempt
All Medtronic Left Ventricular Leads (Attain Family)	181 participants

SECONDARY outcome

Timeframe: Implant

Population: Subjects successfully implanted with a Model 4196 lead.

Cannulation time was defined as the time from insertion of the first CS cannulation catheter to the first CS cannulation.

Outcome measures

Outcome measures
Measure	4196 Lead n=170 Participants Subjects who underwent Model 4196 left ventricular lead implant attempt
Cannulation Time	10.4 minutes Standard Deviation 4.0

SECONDARY outcome

Timeframe: Implant

Population: Subjects successfully implanted with a Model 4196 lead.

Fluoroscopy time was defined as the total time the fluoroscope was imaging.

Outcome measures

Outcome measures
Measure	4196 Lead n=170 Participants Subjects who underwent Model 4196 left ventricular lead implant attempt
Fluoroscopy Time	25.2 minutes Standard Deviation 18.9

SECONDARY outcome

Timeframe: Implant

Population: Subjects successfully implanted with a Model 4196 lead.

Model 4196 lead placement time was defined as the time from insertion of the successfully placed lead to the time when it was placed in the first acceptable pacing location.

Outcome measures

Outcome measures
Measure	4196 Lead n=170 Participants Subjects who underwent Model 4196 left ventricular lead implant attempt
Model 4196 Lead Placement Time	11.9 minutes Standard Deviation 10.0

SECONDARY outcome

Timeframe: Implant

Population: Subjects successfully implanted with a Model 4196 lead.

Total implant time was defined as time from initial incision to final closure.

Outcome measures

Outcome measures
Measure	4196 Lead n=170 Participants Subjects who underwent Model 4196 left ventricular lead implant attempt
Total Implant Time	117.1 minutes Standard Deviation 101.5

SECONDARY outcome

Timeframe: Implant

Population: All available assessments from physicians.

Lead handling characteristics assessed as "acceptable" by physicians

Outcome measures

Outcome measures
Measure	4196 Lead n=177 Participants Subjects who underwent Model 4196 left ventricular lead implant attempt
Assessment of Lead Handling Characteristics	174 participants

SECONDARY outcome

Timeframe: 12-month

Population: Subjects with Model 4196 lead implanted and an intrinsic R-wave available at 12-month visit.

Model 4196 lead tip electrode R-wave amplitude

Outcome measures

Outcome measures
Measure	4196 Lead n=121 Participants Subjects who underwent Model 4196 left ventricular lead implant attempt
Electrical Performance - Tip Electrode: Sensing	17.0 millivolt (mV) Standard Deviation 5.9

SECONDARY outcome

Timeframe: 12-month

Population: Subjects with Model 4196 lead implanted and 12-month visit completed.

Model 4196 lead tip electrode LV voltage threshold

Outcome measures

Outcome measures
Measure	4196 Lead n=131 Participants Subjects who underwent Model 4196 left ventricular lead implant attempt
Electrical Performance - Tip Electrode: LV Voltage Threshold	1.2 Volts Standard Deviation 1.0

SECONDARY outcome

Timeframe: 12-month

Population: Subjects with Model 4196 lead implanted and 12-month visit completed.

Model 4196 lead tip electrode pacing impedance

Outcome measures

Outcome measures
Measure	4196 Lead n=133 Participants Subjects who underwent Model 4196 left ventricular lead implant attempt
Electrical Performance -Tip Electrode: Pacing Impedance	508.7 Ohms Standard Deviation 144.5

SECONDARY outcome

Timeframe: Implant

Population: Subjects with Model 4196 lead implanted and with intrinsic R-wave amplitude at implant.

Model 4196 lead ring electrode R-wave amplitude

Outcome measures

Outcome measures
Measure	4196 Lead n=162 Participants Subjects who underwent Model 4196 left ventricular lead implant attempt
Electrical Performance -Ring Electrode: Sensing	15.4 mV Standard Deviation 6.9

SECONDARY outcome

Timeframe: 12-month

Population: Subjects with Model 4196 lead implanted and 12-month visit completed.

Model 4196 lead ring electrode LV voltage threshold

Outcome measures

Outcome measures
Measure	4196 Lead n=115 Participants Subjects who underwent Model 4196 left ventricular lead implant attempt
Electrical Performance - Ring Electrode: LV Voltage Threshold	2.0 Volts Standard Deviation 2.0

SECONDARY outcome

Timeframe: 12-Month

Population: Subjects with Model 4196 lead implanted and completed 12-month visit.

Model 4196 lead ring electrode pacing impedance

Outcome measures

Outcome measures
Measure	4196 Lead n=133 Participants Subjects who underwent Model 4196 left ventricular lead implant attempt
Electrical Performance -Ring Electrode: Pacing Impedance	497.1 Ohms Standard Deviation 262.9

SECONDARY outcome

Timeframe: Up to 18 months

Population: All subjects enrolled into the 4196 study.

All adverse events were collected for this trial such as, but not limited to, the following: Atrial Fibrillation, Chest Pain, Pneumonia, Cold/Flu

Outcome measures

Outcome measures
Measure	4196 Lead n=190 Participants Subjects who underwent Model 4196 left ventricular lead implant attempt
Summarize All Adverse Events	538 adverse events

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Hang Nguyen

Medtronic CRDM Clinical Research

Phone: 800-328-2518

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Generally, contracts allow investigators to publish study results per the protocol and publication plan. Medtronic reviews publications to determine if confidential information ("CI") is included. Any such CI is deleted before publication. Medtronic may not censor/interfere with the publication. Investigators may publish single-site publications after a decision by Medtronic that no multi-site study publication will be done or 12 months after the study is closed, whichever is earlier.
Publication restrictions are in place

Restriction type: OTHER