Trial Outcomes & Findings for Model 4296 Left Ventricular (LV) Lead Study (NCT NCT00927251)
NCT ID: NCT00927251
Last Updated: 2019-02-18
Results Overview
A LV lead related complication occurs when an invasive procedure is needed to correct an adverse event related to the LV lead.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
90 participants
Primary outcome timeframe
Implant to one-month post implant
Results posted on
2019-02-18
Participant Flow
The trial began with the first subject enrollment on July 1, 2009 and subsequent first implant of the Model 4296 LV lead on July 2, 2009. A total of 90 subjects were enrolled in the study of which 82 were successfully implanted with a Model 4296 LV lead. Last enrollment took place on December 16, 2009.
Participant milestones
| Measure |
Model 4296 LV Lead Study
This study is a prospective, multi-center, non-randomized, one-arm clinical trial using Objective Performance Criteria (OPC) to evaluate the safety and efficacy of the Model 4296 LV lead. The OPC based trial design is consistent with the designs used to evaluate all current market released Medtronic left ventricular leads. The Model 4296 LV lead is designed to provide physicians with acceptable unipolar pacing from two selectable electrodes.All subjects are planned to undergo a CRT system implant and will be followed through at least pre-hospital discharge and one month visit.
|
|---|---|
|
Overall Study
STARTED
|
90
|
|
Overall Study
COMPLETED
|
82
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Model 4296 LV Lead Study
This study is a prospective, multi-center, non-randomized, one-arm clinical trial using Objective Performance Criteria (OPC) to evaluate the safety and efficacy of the Model 4296 LV lead. The OPC based trial design is consistent with the designs used to evaluate all current market released Medtronic left ventricular leads. The Model 4296 LV lead is designed to provide physicians with acceptable unipolar pacing from two selectable electrodes.All subjects are planned to undergo a CRT system implant and will be followed through at least pre-hospital discharge and one month visit.
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|---|---|
|
Overall Study
Patients not implanted with 4296 lead
|
8
|
Baseline Characteristics
Model 4296 Left Ventricular (LV) Lead Study
Baseline characteristics by cohort
| Measure |
Model 4296 LV Lead Study
n=90 Participants
This study is a prospective, multi-center, non-randomized, one-arm clinical trial using Objective Performance Criteria (OPC) to evaluate the safety and efficacy of the Model 4296 LV lead. The OPC based trial design is consistent with the designs used to evaluate all current market released Medtronic left ventricular leads. The Model 4296 LV lead is designed to provide physicians with acceptable unipolar pacing from two selectable electrodes.All subjects are planned to undergo a CRT system implant and will be followed through at least pre-hospital discharge and one month visit.
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|---|---|
|
Age, Continuous
|
67.0 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=5 Participants
|
|
Region of Enrollment
Slovakia
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
43 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
9 participants
n=5 Participants
|
|
New York Heart Association Functional Classification
NYHA Class II
|
3 participants
n=5 Participants
|
|
New York Heart Association Functional Classification
NYHA Class III
|
86 participants
n=5 Participants
|
|
New York Heart Association Functional Classification
NYHA Class IV
|
1 participants
n=5 Participants
|
|
Left Ventricular Ejection Fraction
|
25.6 Percentage (%)
STANDARD_DEVIATION 6.5 • n=5 Participants
|
|
QRS Duration
|
159.0 milliseconds
STANDARD_DEVIATION 21.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: Implant to one-month post implantPopulation: All subjects implanted with the lead who had completed their one-month post-implant/or a later follow-up visit, or have had a complication by the one-month post-implant visit, were included in the analysis. A complication is defined as an Adverse Event that results in death, any termination of significant device function or invasive intervention
A LV lead related complication occurs when an invasive procedure is needed to correct an adverse event related to the LV lead.
Outcome measures
| Measure |
Model 4296 LV Lead Study
n=67 Participants
This study is a prospective, multi-center, non-randomized, one-arm clinical trial using Objective Performance Criteria (OPC) to evaluate the safety and efficacy of the Model 4296 LV lead. The OPC based trial design is consistent with the designs used to evaluate all current market released Medtronic left ventricular leads. The Model 4296 LV lead is designed to provide physicians with acceptable unipolar pacing from two selectable electrodes.All subjects are planned to undergo a CRT system implant and will be followed through at least pre-hospital discharge and one month visit.
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|---|---|
|
Number of Participants With Left Ventricular (LV)Lead Related Complications
|
1 participants
|
Adverse Events
Model 4296 LV Lead Study
Serious events: 16 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Model 4296 LV Lead Study
n=90 participants at risk
This study is a prospective, multi-center, non-randomized, one-arm clinical trial using Objective Performance Criteria (OPC) to evaluate the safety and efficacy of the Model 4296 LV lead. The OPC based trial design is consistent with the designs used to evaluate all current market released Medtronic left ventricular leads. The Model 4296 LV lead is designed to provide physicians with acceptable unipolar pacing from two selectable electrodes.All subjects are planned to undergo a CRT system implant and will be followed through at least pre-hospital discharge and one month visit.
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
1.1%
1/90 • Number of events 1 • Adverse events were collected for the total duration of the study (from patient signing informed consent until study exit/study closure).The data provided shows adverse events reported until the last enrolled patient had completed his/her one month visit.
At each follow up, patients were asked whether an adverse event had occurred.A patient was not allowed to exit the study until all relevant implant related AEs were resolved or determined to be irresolvable.
|
|
Infections and infestations
Catheter infection
|
1.1%
1/90 • Number of events 1 • Adverse events were collected for the total duration of the study (from patient signing informed consent until study exit/study closure).The data provided shows adverse events reported until the last enrolled patient had completed his/her one month visit.
At each follow up, patients were asked whether an adverse event had occurred.A patient was not allowed to exit the study until all relevant implant related AEs were resolved or determined to be irresolvable.
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.1%
1/90 • Number of events 1 • Adverse events were collected for the total duration of the study (from patient signing informed consent until study exit/study closure).The data provided shows adverse events reported until the last enrolled patient had completed his/her one month visit.
At each follow up, patients were asked whether an adverse event had occurred.A patient was not allowed to exit the study until all relevant implant related AEs were resolved or determined to be irresolvable.
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
1.1%
1/90 • Number of events 1 • Adverse events were collected for the total duration of the study (from patient signing informed consent until study exit/study closure).The data provided shows adverse events reported until the last enrolled patient had completed his/her one month visit.
At each follow up, patients were asked whether an adverse event had occurred.A patient was not allowed to exit the study until all relevant implant related AEs were resolved or determined to be irresolvable.
|
|
Cardiac disorders
Decompensated heart failure
|
1.1%
1/90 • Number of events 1 • Adverse events were collected for the total duration of the study (from patient signing informed consent until study exit/study closure).The data provided shows adverse events reported until the last enrolled patient had completed his/her one month visit.
At each follow up, patients were asked whether an adverse event had occurred.A patient was not allowed to exit the study until all relevant implant related AEs were resolved or determined to be irresolvable.
|
|
Nervous system disorders
Embolic stroke
|
1.1%
1/90 • Number of events 1 • Adverse events were collected for the total duration of the study (from patient signing informed consent until study exit/study closure).The data provided shows adverse events reported until the last enrolled patient had completed his/her one month visit.
At each follow up, patients were asked whether an adverse event had occurred.A patient was not allowed to exit the study until all relevant implant related AEs were resolved or determined to be irresolvable.
|
|
Injury, poisoning and procedural complications
Exit block
|
1.1%
1/90 • Number of events 1 • Adverse events were collected for the total duration of the study (from patient signing informed consent until study exit/study closure).The data provided shows adverse events reported until the last enrolled patient had completed his/her one month visit.
At each follow up, patients were asked whether an adverse event had occurred.A patient was not allowed to exit the study until all relevant implant related AEs were resolved or determined to be irresolvable.
|
|
Injury, poisoning and procedural complications
Femur fracture subtrochanteric
|
1.1%
1/90 • Number of events 1 • Adverse events were collected for the total duration of the study (from patient signing informed consent until study exit/study closure).The data provided shows adverse events reported until the last enrolled patient had completed his/her one month visit.
At each follow up, patients were asked whether an adverse event had occurred.A patient was not allowed to exit the study until all relevant implant related AEs were resolved or determined to be irresolvable.
|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
1.1%
1/90 • Number of events 1 • Adverse events were collected for the total duration of the study (from patient signing informed consent until study exit/study closure).The data provided shows adverse events reported until the last enrolled patient had completed his/her one month visit.
At each follow up, patients were asked whether an adverse event had occurred.A patient was not allowed to exit the study until all relevant implant related AEs were resolved or determined to be irresolvable.
|
|
Infections and infestations
Infection
|
2.2%
2/90 • Number of events 2 • Adverse events were collected for the total duration of the study (from patient signing informed consent until study exit/study closure).The data provided shows adverse events reported until the last enrolled patient had completed his/her one month visit.
At each follow up, patients were asked whether an adverse event had occurred.A patient was not allowed to exit the study until all relevant implant related AEs were resolved or determined to be irresolvable.
|
|
Injury, poisoning and procedural complications
Lead dislodgement
|
2.2%
2/90 • Number of events 2 • Adverse events were collected for the total duration of the study (from patient signing informed consent until study exit/study closure).The data provided shows adverse events reported until the last enrolled patient had completed his/her one month visit.
At each follow up, patients were asked whether an adverse event had occurred.A patient was not allowed to exit the study until all relevant implant related AEs were resolved or determined to be irresolvable.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.1%
1/90 • Number of events 1 • Adverse events were collected for the total duration of the study (from patient signing informed consent until study exit/study closure).The data provided shows adverse events reported until the last enrolled patient had completed his/her one month visit.
At each follow up, patients were asked whether an adverse event had occurred.A patient was not allowed to exit the study until all relevant implant related AEs were resolved or determined to be irresolvable.
|
|
Infections and infestations
Pleuropneumonia
|
1.1%
1/90 • Number of events 1 • Adverse events were collected for the total duration of the study (from patient signing informed consent until study exit/study closure).The data provided shows adverse events reported until the last enrolled patient had completed his/her one month visit.
At each follow up, patients were asked whether an adverse event had occurred.A patient was not allowed to exit the study until all relevant implant related AEs were resolved or determined to be irresolvable.
|
|
Nervous system disorders
Syncope vasovagal
|
1.1%
1/90 • Number of events 1 • Adverse events were collected for the total duration of the study (from patient signing informed consent until study exit/study closure).The data provided shows adverse events reported until the last enrolled patient had completed his/her one month visit.
At each follow up, patients were asked whether an adverse event had occurred.A patient was not allowed to exit the study until all relevant implant related AEs were resolved or determined to be irresolvable.
|
|
Cardiac disorders
Ventricular tachycardia
|
2.2%
2/90 • Number of events 5 • Adverse events were collected for the total duration of the study (from patient signing informed consent until study exit/study closure).The data provided shows adverse events reported until the last enrolled patient had completed his/her one month visit.
At each follow up, patients were asked whether an adverse event had occurred.A patient was not allowed to exit the study until all relevant implant related AEs were resolved or determined to be irresolvable.
|
Other adverse events
| Measure |
Model 4296 LV Lead Study
n=90 participants at risk
This study is a prospective, multi-center, non-randomized, one-arm clinical trial using Objective Performance Criteria (OPC) to evaluate the safety and efficacy of the Model 4296 LV lead. The OPC based trial design is consistent with the designs used to evaluate all current market released Medtronic left ventricular leads. The Model 4296 LV lead is designed to provide physicians with acceptable unipolar pacing from two selectable electrodes.All subjects are planned to undergo a CRT system implant and will be followed through at least pre-hospital discharge and one month visit.
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
1.1%
1/90 • Number of events 1 • Adverse events were collected for the total duration of the study (from patient signing informed consent until study exit/study closure).The data provided shows adverse events reported until the last enrolled patient had completed his/her one month visit.
At each follow up, patients were asked whether an adverse event had occurred.A patient was not allowed to exit the study until all relevant implant related AEs were resolved or determined to be irresolvable.
|
|
Cardiac disorders
Atrial flutter
|
3.3%
3/90 • Number of events 3 • Adverse events were collected for the total duration of the study (from patient signing informed consent until study exit/study closure).The data provided shows adverse events reported until the last enrolled patient had completed his/her one month visit.
At each follow up, patients were asked whether an adverse event had occurred.A patient was not allowed to exit the study until all relevant implant related AEs were resolved or determined to be irresolvable.
|
|
Eye disorders
Conjunctivitis
|
1.1%
1/90 • Number of events 1 • Adverse events were collected for the total duration of the study (from patient signing informed consent until study exit/study closure).The data provided shows adverse events reported until the last enrolled patient had completed his/her one month visit.
At each follow up, patients were asked whether an adverse event had occurred.A patient was not allowed to exit the study until all relevant implant related AEs were resolved or determined to be irresolvable.
|
|
Injury, poisoning and procedural complications
Device lead issue
|
2.2%
2/90 • Number of events 2 • Adverse events were collected for the total duration of the study (from patient signing informed consent until study exit/study closure).The data provided shows adverse events reported until the last enrolled patient had completed his/her one month visit.
At each follow up, patients were asked whether an adverse event had occurred.A patient was not allowed to exit the study until all relevant implant related AEs were resolved or determined to be irresolvable.
|
|
Nervous system disorders
Dizziness
|
1.1%
1/90 • Number of events 1 • Adverse events were collected for the total duration of the study (from patient signing informed consent until study exit/study closure).The data provided shows adverse events reported until the last enrolled patient had completed his/her one month visit.
At each follow up, patients were asked whether an adverse event had occurred.A patient was not allowed to exit the study until all relevant implant related AEs were resolved or determined to be irresolvable.
|
|
General disorders
Drug side effect
|
1.1%
1/90 • Number of events 1 • Adverse events were collected for the total duration of the study (from patient signing informed consent until study exit/study closure).The data provided shows adverse events reported until the last enrolled patient had completed his/her one month visit.
At each follow up, patients were asked whether an adverse event had occurred.A patient was not allowed to exit the study until all relevant implant related AEs were resolved or determined to be irresolvable.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.2%
2/90 • Number of events 2 • Adverse events were collected for the total duration of the study (from patient signing informed consent until study exit/study closure).The data provided shows adverse events reported until the last enrolled patient had completed his/her one month visit.
At each follow up, patients were asked whether an adverse event had occurred.A patient was not allowed to exit the study until all relevant implant related AEs were resolved or determined to be irresolvable.
|
|
Reproductive system and breast disorders
Gynecomastia
|
1.1%
1/90 • Number of events 1 • Adverse events were collected for the total duration of the study (from patient signing informed consent until study exit/study closure).The data provided shows adverse events reported until the last enrolled patient had completed his/her one month visit.
At each follow up, patients were asked whether an adverse event had occurred.A patient was not allowed to exit the study until all relevant implant related AEs were resolved or determined to be irresolvable.
|
|
Vascular disorders
Haematoma
|
1.1%
1/90 • Number of events 1 • Adverse events were collected for the total duration of the study (from patient signing informed consent until study exit/study closure).The data provided shows adverse events reported until the last enrolled patient had completed his/her one month visit.
At each follow up, patients were asked whether an adverse event had occurred.A patient was not allowed to exit the study until all relevant implant related AEs were resolved or determined to be irresolvable.
|
|
Vascular disorders
Hypertension
|
1.1%
1/90 • Number of events 1 • Adverse events were collected for the total duration of the study (from patient signing informed consent until study exit/study closure).The data provided shows adverse events reported until the last enrolled patient had completed his/her one month visit.
At each follow up, patients were asked whether an adverse event had occurred.A patient was not allowed to exit the study until all relevant implant related AEs were resolved or determined to be irresolvable.
|
|
Injury, poisoning and procedural complications
Inappropriate phrenic nerve stimulation
|
11.1%
10/90 • Number of events 12 • Adverse events were collected for the total duration of the study (from patient signing informed consent until study exit/study closure).The data provided shows adverse events reported until the last enrolled patient had completed his/her one month visit.
At each follow up, patients were asked whether an adverse event had occurred.A patient was not allowed to exit the study until all relevant implant related AEs were resolved or determined to be irresolvable.
|
|
Injury, poisoning and procedural complications
Inappropriate stimulation of diaphragm
|
1.1%
1/90 • Number of events 1 • Adverse events were collected for the total duration of the study (from patient signing informed consent until study exit/study closure).The data provided shows adverse events reported until the last enrolled patient had completed his/her one month visit.
At each follow up, patients were asked whether an adverse event had occurred.A patient was not allowed to exit the study until all relevant implant related AEs were resolved or determined to be irresolvable.
|
|
Infections and infestations
Infection urinary tract
|
1.1%
1/90 • Number of events 1 • Adverse events were collected for the total duration of the study (from patient signing informed consent until study exit/study closure).The data provided shows adverse events reported until the last enrolled patient had completed his/her one month visit.
At each follow up, patients were asked whether an adverse event had occurred.A patient was not allowed to exit the study until all relevant implant related AEs were resolved or determined to be irresolvable.
|
|
Injury, poisoning and procedural complications
Lead dislodgement
|
1.1%
1/90 • Number of events 1 • Adverse events were collected for the total duration of the study (from patient signing informed consent until study exit/study closure).The data provided shows adverse events reported until the last enrolled patient had completed his/her one month visit.
At each follow up, patients were asked whether an adverse event had occurred.A patient was not allowed to exit the study until all relevant implant related AEs were resolved or determined to be irresolvable.
|
|
Nervous system disorders
Loss of sensation
|
1.1%
1/90 • Number of events 1 • Adverse events were collected for the total duration of the study (from patient signing informed consent until study exit/study closure).The data provided shows adverse events reported until the last enrolled patient had completed his/her one month visit.
At each follow up, patients were asked whether an adverse event had occurred.A patient was not allowed to exit the study until all relevant implant related AEs were resolved or determined to be irresolvable.
|
|
Injury, poisoning and procedural complications
Medical device pain
|
1.1%
1/90 • Number of events 1 • Adverse events were collected for the total duration of the study (from patient signing informed consent until study exit/study closure).The data provided shows adverse events reported until the last enrolled patient had completed his/her one month visit.
At each follow up, patients were asked whether an adverse event had occurred.A patient was not allowed to exit the study until all relevant implant related AEs were resolved or determined to be irresolvable.
|
|
Cardiac disorders
Palpitations
|
1.1%
1/90 • Number of events 1 • Adverse events were collected for the total duration of the study (from patient signing informed consent until study exit/study closure).The data provided shows adverse events reported until the last enrolled patient had completed his/her one month visit.
At each follow up, patients were asked whether an adverse event had occurred.A patient was not allowed to exit the study until all relevant implant related AEs were resolved or determined to be irresolvable.
|
|
Cardiac disorders
Pericardial effusion
|
1.1%
1/90 • Number of events 1 • Adverse events were collected for the total duration of the study (from patient signing informed consent until study exit/study closure).The data provided shows adverse events reported until the last enrolled patient had completed his/her one month visit.
At each follow up, patients were asked whether an adverse event had occurred.A patient was not allowed to exit the study until all relevant implant related AEs were resolved or determined to be irresolvable.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.1%
1/90 • Number of events 1 • Adverse events were collected for the total duration of the study (from patient signing informed consent until study exit/study closure).The data provided shows adverse events reported until the last enrolled patient had completed his/her one month visit.
At each follow up, patients were asked whether an adverse event had occurred.A patient was not allowed to exit the study until all relevant implant related AEs were resolved or determined to be irresolvable.
|
|
Cardiac disorders
Recurrent atrial fibrillation
|
1.1%
1/90 • Number of events 1 • Adverse events were collected for the total duration of the study (from patient signing informed consent until study exit/study closure).The data provided shows adverse events reported until the last enrolled patient had completed his/her one month visit.
At each follow up, patients were asked whether an adverse event had occurred.A patient was not allowed to exit the study until all relevant implant related AEs were resolved or determined to be irresolvable.
|
|
Infections and infestations
Skin infection
|
1.1%
1/90 • Number of events 1 • Adverse events were collected for the total duration of the study (from patient signing informed consent until study exit/study closure).The data provided shows adverse events reported until the last enrolled patient had completed his/her one month visit.
At each follow up, patients were asked whether an adverse event had occurred.A patient was not allowed to exit the study until all relevant implant related AEs were resolved or determined to be irresolvable.
|
|
Cardiac disorders
Tachyarrhtythmia absoluta
|
1.1%
1/90 • Number of events 1 • Adverse events were collected for the total duration of the study (from patient signing informed consent until study exit/study closure).The data provided shows adverse events reported until the last enrolled patient had completed his/her one month visit.
At each follow up, patients were asked whether an adverse event had occurred.A patient was not allowed to exit the study until all relevant implant related AEs were resolved or determined to be irresolvable.
|
Additional Information
Model 4296 Left Ventricular (LV) Lead Study Sr. CRS
Medtronic, Bakken Research Center
Phone: +31-43-3566602
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