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This study is designed to show that a new lead, which paces the left bottom chamber (left ventricle) of the heart, is safe. Using a lead on the left side of the heart has been shown to potentially improve heart failure symptoms. The shape and size of this new lead may make it a good choice for patients or physicians.
This study is a prospective, multi-center, non-randomized design trial. All consented patients who meet all inclusion and no exclusion criteria may receive the investigational lead. The study design has statistical power to show safety at one-month after implant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Model 4296 LV Lead | Experimental | Non-randomized study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pacing Lead (Model 4296 LV Lead) | Device | Implant and follow-up of study device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Left Ventricular (LV)Lead Related Complications | A LV lead related complication occurs when an invasive procedure is needed to correct an adverse event related to the LV lead. | Implant to one-month post implant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| M. Biffi, M.D. | Policlinico S. Orsola-Malpighi in Bologna, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linz | Austria | |||||
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Left Ventricular (LV)Lead Related Complications | A LV lead related complication occurs when an invasive procedure is needed to correct an adverse event related to the LV lead. | 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 | Posted | Number | participants | Implant to one-month post implant |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Model 4296 Left Ventricular (LV) Lead Study Sr. CRS | Medtronic, Bakken Research Center | +31-43-3566602 | margriet.kruijshoop@medtronic.com |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Vienna |
| Austria |
| Oulu | Finland |
| Bad Rothenfelde | Germany |
| Essen | Germany |
| Heidelberg | Germany |
| Lüdenscheid | Germany |
| Ulm | Germany |
| Delhi | India |
| Bologna | Italy |
| Pesaro | Italy |
| Rovigo | Italy |
| Breda | Netherlands |
| Eindhoven | Netherlands |
| Bergen | Norway |
| Košice | Slovakia |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| New York Heart Association Functional Classification | Class I No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea. Class II Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea. Class III Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased. | Number | participants |
|
| Left Ventricular Ejection Fraction | The Left Ventricular Ejection fraction is the percentage of blood ejected from the left ventricle with each heart beat. | Mean | Standard Deviation | Percentage (%) |
|
| QRS Duration | Mean | Standard Deviation | milliseconds |
|
|
|
| 16 |
| 90 |
| 26 |
| 90 |
| Catheter infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
|
| COPD exacerbation | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Decompensated heart failure | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Embolic stroke | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Exit block | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Femur fracture subtrochanteric | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Gastrointestinal bleeding | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Lead dislodgement | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pleuropneumonia | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Syncope vasovagal | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Device lead issue | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Drug side effect | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Gynecomastia | Reproductive system and breast disorders | MedDRA (11.0) | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Inappropriate phrenic nerve stimulation | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Inappropriate stimulation of diaphragm | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Infection urinary tract | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Lead dislodgement | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Loss of sensation | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Medical device pain | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Recurrent atrial fibrillation | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Tachyarrhtythmia absoluta | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
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.