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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00853593




Registration number
NCT00853593
Ethics application status
Date submitted
26/02/2009
Date registered
2/03/2009
Date last updated
18/02/2019

Titles & IDs
Public title
Model 4396 Left Ventricular (LV) Lead Study
Scientific title
Model 4396 Left Ventricular Lead Study
Secondary ID [1] 0 0
116
Universal Trial Number (UTN)
Trial acronym
4396
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Pacing Lead

Experimental: Model 4396 LV Lead - Non-randomized study.


Treatment: Devices: Pacing Lead
implant and follow-up of study device
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety (Subjects Without a Model 4396 Lead Related Complication)
Timepoint [1] 0 0
One month
Primary outcome [2] 0 0
Efficacy: Distal Tip Electrode Voltage Threshold
Timepoint [2] 0 0
One month
Primary outcome [3] 0 0
Efficacy: Proximal Ring Voltage Threshold
Timepoint [3] 0 0
Three months
Secondary outcome [1] 0 0
Subjects Successfully Implanted With Model 4396 Lead
Timepoint [1] 0 0
During implant procedure.
Secondary outcome [2] 0 0
Subjects Successfully Implanted With Any Transvenous LV Lead After Cannulation
Timepoint [2] 0 0
During implant procedure.
Secondary outcome [3] 0 0
Subjects Successfully Implanted With Any Transvenous LV Lead
Timepoint [3] 0 0
During implant procedure.
Secondary outcome [4] 0 0
Subjects Successfully Implanted With Any Medtronic Attain Family LV Lead
Timepoint [4] 0 0
During implant procedure.
Secondary outcome [5] 0 0
Cannulation Time
Timepoint [5] 0 0
During implant procedure.
Secondary outcome [6] 0 0
Fluoroscopy Time
Timepoint [6] 0 0
During implant procedure.
Secondary outcome [7] 0 0
Model 4396 Lead Placement Time
Timepoint [7] 0 0
During implant procedure.
Secondary outcome [8] 0 0
Total Operation Time
Timepoint [8] 0 0
During implant procedure.
Secondary outcome [9] 0 0
Assessment of Lead Handling Characteristics Reported as Acceptable
Timepoint [9] 0 0
During implant procedure.
Secondary outcome [10] 0 0
Efficacy: Bipolar Voltage Threshold
Timepoint [10] 0 0
1 month
Secondary outcome [11] 0 0
Characterize Model 4396 Electrical Performance- Tip Electrode: Voltage Threshold
Timepoint [11] 0 0
6 month
Secondary outcome [12] 0 0
Characterize Model 4396 Electrical Performance- Tip Electrode: Pacing Impedance
Timepoint [12] 0 0
6 month
Secondary outcome [13] 0 0
Characterize Model 4396 Electrical Performance- Tip Electrode: Sensing
Timepoint [13] 0 0
6 month
Secondary outcome [14] 0 0
Characterize Model 4396 Electrical Performance- Ring Electrode: Voltage Threshold
Timepoint [14] 0 0
6 month
Secondary outcome [15] 0 0
Characterize Model 4396 Electrical Performance- Ring Electrode: Pacing Impedance
Timepoint [15] 0 0
6 month
Secondary outcome [16] 0 0
Characterize Model 4396 Electrical Performance- Ring Electrode: Sensing
Timepoint [16] 0 0
During implant procedure.
Secondary outcome [17] 0 0
Characterize Model 4396 Electrical Performance- Bipolar Configuration: Voltage Threshold
Timepoint [17] 0 0
6 month
Secondary outcome [18] 0 0
Characterize Model 4396 Electrical Performance- Bipolar Configuration: Pacing Impedance
Timepoint [18] 0 0
6 month
Secondary outcome [19] 0 0
Characterize Model 4396 Electrical Performance- Bipolar Configuration: Sensing
Timepoint [19] 0 0
6 month

Eligibility
Key inclusion criteria
* CRT/Cardiac Resynchronization Therapy-Defibrillator (CRT-D) indications, New York Heart Association (NYHA) III and IV, indicated for implantable cardiac defibrillator (ICD) if CRT-D is implanted, patient consent, geographically stable
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* LV lead implant attempt in last 30 days, unstable angina or acute myocardial infarction (MI) in past 30 days, coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) in past 3 months, contraindicated for transvenous pacing, heart transplant

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2010
Sample size
Target
Accrual to date
Final
197
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Bendigo
Recruitment postcode(s) [1] 0 0
- Bendigo
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Iowa
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Oregon
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
West Virginia
Country [17] 0 0
Austria
State/province [17] 0 0
Linz
Country [18] 0 0
Canada
State/province [18] 0 0
Alberta
Country [19] 0 0
Canada
State/province [19] 0 0
British Columbia
Country [20] 0 0
Canada
State/province [20] 0 0
Ontario
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
Denmark
State/province [22] 0 0
Aarhus
Country [23] 0 0
France
State/province [23] 0 0
Nantes
Country [24] 0 0
France
State/province [24] 0 0
Toulouse
Country [25] 0 0
Italy
State/province [25] 0 0
Treviso
Country [26] 0 0
Saudi Arabia
State/province [26] 0 0
Riyadh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Medtronic Cardiac Rhythm and Heart Failure
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is designed to show that a new lead, which paces the left bottom chamber (left ventricle) of the heart, is safe and effective. 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.
Trial website
https://clinicaltrials.gov/study/NCT00853593
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Derek Exner, MD
Address 0 0
Foothills Hospital (University of Calgary)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00853593