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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00180336 |
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Date of registration:
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12/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Safety and Efficacy Study of RENEWAL 4 AVT
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Scientific title:
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CONTAK RENEWAL 4 AVT Field Following |
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Date of first enrolment:
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July 2004 |
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Target sample size:
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170 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00180336 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Germany
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Contacts
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Name:
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Johannes Sperzel, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Kerckhoff Klinik Bad Nauheim (Germany) |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Indications for the device
- Availability for follow-up at an approved Field Following center, at the protocol
defined intervals
- Willing and capable of undergoing a device implant and participating in all testing
associated with this clinical investigation
- Prescribed to stable optimal pharmacologic therapy for HF
- Age 18 or above, or of legal age to give informed consent specific to national law
- Able to provide documented evidence of one or more episodes of AF/AT within 12 months
of implantation NOTE: Guidant recommends anticoagulation therapy per physician
discretion.
Exclusion Criteria:
- Right bundle branch block morphology
- Life expectancy of less than six months due to other medical conditions
- Expectation of a heart transplant during the period of the study
- Patients with or who are likely to receive a mechanical tricuspid valve during the
course of the study
- Have a preexisting unipolar pacemaker that will not be explanted/abandoned
- Have an atrial tachyarrhythmia that is permanent (i.e., does not terminate
spontaneously and cannot be terminated with medical intervention) within 180 days
prior to enrollment
- Have a known hypersensitivity to dexamethasone acetate
- Enrolled in any other study, including drug investigation
- Women that are pregnant or planning to become pregnant
- A Cerebral Vascular Event/ Transient Ischemic Attack within 12 months of implantation
- During the four weeks prior to implantation, a patient experiences an episode of AF
>= 48 hours in duration and was not anticoagulated for at an adequate therapeutic
level (INR >= 2.0) for the 4 weeks prior to enrollment
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Atrial Flutter
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Heart Failure
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Atrial Fibrillation
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Ventricular Fibrillation
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Tachycardia
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Intervention(s)
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Device: CRT-D
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Primary Outcome(s)
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System Complication-Free Rate at 6 months
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Effectiveness of LV Only/LV Offset at 6 months
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Secondary Outcome(s)
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NYHA at 6 months
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Six-minute walk at 6 months
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LVESD at 6 months
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QOL at 6 months
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Secondary ID(s)
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Clinicals0004
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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