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Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (CRT) may be prescribed. CRT is similar to a pacemaker. It is placed (implanted) under the skin of the upper chest. CRT is delivered as tiny electrical pulses to the right and left ventricles through three leads (flexible insulated wires) that are inserted through the veins to the heart. The purpose of this study is to evaluate a new lead for delivering energy to the left ventricle (bottom left chamber of the heart).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 20066 Lead | Experimental | Non-randomized study. Intervention: Device: Pacing Lead |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pacing Lead | Device | Implant and follow up of Model 20066 lead |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of implant procedure related and lead-related complications in the first month post-implant | One Month |
| Measure | Description | Time Frame |
|---|---|---|
| Success rate of the Model 20066 lead | Within 24 hours of procedure initiation | |
| Cannulation time | Within 24 hours of procedure initiation | |
| Fluoroscopy Time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raymond Yee, MD | London Health Sciences Centre, London, Ontario, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London | Canada | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24801899 | Result | Yee R, Gadler F, Hussin A, Bin Omar R, Khaykin Y, Verma A, Lazeroms M, Hine DS, Marquard KR. Novel active fixation mechanism permits precise placement of a left ventricular lead: early results from a multicenter clinical study. Heart Rhythm. 2014 Jul;11(7):1150-5. doi: 10.1016/j.hrthm.2014.04.020. Epub 2014 May 4. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Within 24 hours of procedure initiation |
| Model 20066 Lead Placement Time | Within 24 hours of procedure initiation |
| Total Implant Time | Within 24 hours of procedure initiation |
| Assessment of Lead Handling Characteristics | Within 24 hours of procedure initiation |
| Electrical Performance-Tip Electrode: LV Voltage Threshold | 12-month |
| Electrical Performance -Tip Electrode: Sensing | 12-month |
| Electrical Performance -Tip Electrode: Pacing Impedance | 12-month |
| Electrical Performance -Ring Electrode: LV Voltage Threshold | 12-month |
| Electrical Performance -Ring Electrode: Sensing | Within 24 hours of procedure initiation |
| Electrical Performance -Ring Electrode: Pacing Impedance | 12-month |
| Summarize All Adverse Events | 12-month |
| Summarize Final 20066 Lead Position | Within 24 hours of procedure initiation |
| Newmarket |
| Canada |
| Kuala Lumpur | Malaysia |
| Stockholm | Sweden |