EASYTRAK 3 Downsize Lead
This study has been completed.
Sponsor:
Boston Scientific Corporation
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00384722
First received: October 3, 2006
Last updated: June 23, 2009
Last verified: June 2009
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Purpose
The primary objective of this clinical investigation is to evaluate the safety and effectiveness of the EASYTRAK 3 Downsize Lead.
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Failure |
Device: EASYTRAK 3 Downsize Lead |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | EASYTRAK® 3 Downsize Lead Clinical Investigation |
Resource links provided by NLM:
Further study details as provided by Boston Scientific Corporation:
Primary Outcome Measures:
- Lead-related complication-free rate at one-month [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
- Chronic mean pacing thresholds at one-month. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Chronic mean R-wave amplitudes at one-month [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
- Chronic mean pacing impedances at one-month. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
| Enrollment: | 70 |
| Study Start Date: | March 2006 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Device: EASYTRAK 3 Downsize Lead
EASYTRAK 3 Downsize Lead
This is a prospective, non-randomized, multi-center US clinical investigation, designed to demonstrate the safety and effectiveness of the Guidant EASYTRAK 3 Downsize Lead in humans.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Must be indicated for a Guidant CRT-P or CRT-D device
- Creatinine < 2.5 mg/dL obtained no more than two weeks prior to enrollment
- Age 18 or above, or of legal age to give informed consent specific to state and national law
- Willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigation center and at the intervals defined by this protocol
- Geographically stable residents who are available for follow-up
Exclusion Criteria:
- Have a known hypersensitivity to a 0.5 mg nominal dose of dexamethasone acetate
- Have or had previous cardiac resynchronization therapy, a coronary venous pace/sense lead or attempted LV lead placement
- Have pre-existing cardioversion/defibrillation leads or right ventricular pacing leads other than those specified in the investigational plan (unless the investigator intends to replace them with permitted cardioversion/defibrillation leads)
- Currently requiring dialysis
- Have had a myocardial infarct, unstable angina, percutaneous coronary intervention, or coronary artery bypass graft during the preceding 30 days prior to enrollment
- Have hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis)
- Documented life expectancy of less than six months or expected to undergo heart transplant within the next six months
- Enrolled or participating in any concurrent study, including drug investigations, without Guidant written approval, that may confound the results of this study
- Have a pre-existing unipolar pacemaker that will not be explanted/abandoned
- Have a mechanical tricuspid heart valve
- Women who are pregnant or plan to become pregnant. Note: Women of childbearing potential must have a negative pregnancy test within seven days of enrollment.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00384722
Locations
| United States, Minnesota | |
| Multiple Locations | |
| St. Paul, Minnesota, United States, 55112 | |
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
| Principal Investigator: | John Hummel, MD | Riverside Methodist Hospital |
More Information
Additional Information:
Heart Failure 
No publications provided
| Responsible Party: | Steven McQuillan, Director of Clinical Affairs, Boston Scientific |
| ClinicalTrials.gov Identifier: | NCT00384722 History of Changes |
| Other Study ID Numbers: | Clinicals0011 |
| Study First Received: | October 3, 2006 |
| Last Updated: | June 23, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Boston Scientific Corporation:
|
Left ventricular lead Pacing Heart Failure |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 22, 2013