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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)
Assessment method [1] 0 0
A subject who was free of a Model 4396 lead related complication by the one month visit. All adverse events (AE) in the time frame were recorded at the subject's center and assessed by a centralized Adverse Event Advisory Committee (AEAC). The AEAC determined whether an AE was a complication and whether the event was related to the Model 4396 lead. A complication is an AE that results in death, termination of significant device function or invasive intervention (any therapy that penetrates the skin including administration of intramuscular (IM) and parenteral (IV) fluids).
Timepoint [1] 0 0
One month
Primary outcome [2] 0 0
Efficacy: Distal Tip Electrode Voltage Threshold
Assessment method [2] 0 0
Subjects' distal tip electrode voltage threshold was collected at the one month visit. The Model 4396 was considered effective if the mean voltage threshold was less than 3.0 Volts. Voltage threshold was collected using LV tip to Right Ventricular (RV) coil configuration at 0.5 milliseconds \[ms\]. Voltage threshold is the minimum energy required from the device to consistently pace the ventricle.
Timepoint [2] 0 0
One month
Primary outcome [3] 0 0
Efficacy: Proximal Ring Voltage Threshold
Assessment method [3] 0 0
Subject's proximal ring electrode voltage threshold was collected at the three months visit. The Model 4396 was considered effective if the mean voltage threshold was less than 3.0 Volts.
Timepoint [3] 0 0
Three months
Secondary outcome [1] 0 0
Subjects Successfully Implanted With Model 4396 Lead
Assessment method [1] 0 0
A successful implant occurs when the Model 4396 lead is implanted in a left ventricular vein and functions appropriately. A Model 4396 implant attempt was defined as any time when a Model 4396 lead was introduced into the body.
Timepoint [1] 0 0
During implant procedure.
Secondary outcome [2] 0 0
Subjects Successfully Implanted With Any Transvenous LV Lead After Cannulation
Assessment method [2] 0 0
A successful implant after cannulation occurs when the coronary sinus (CS) is successfully cannulated and a left ventricular lead (any transvenous LV lead) is implanted in a left ventricular vein and functions appropriately. An implant attempt of any transvenous LV lead was defined as any time when a transvenous LV lead was introduced into the body.
Timepoint [2] 0 0
During implant procedure.
Secondary outcome [3] 0 0
Subjects Successfully Implanted With Any Transvenous LV Lead
Assessment method [3] 0 0
A successful implant occurs when any transvenous LV lead is implanted in a left ventricular vein functions appropriately.
Timepoint [3] 0 0
During implant procedure.
Secondary outcome [4] 0 0
Subjects Successfully Implanted With Any Medtronic Attain Family LV Lead
Assessment method [4] 0 0
A successful implant occurs when any Medtronic Attain Family LV Lead is implanted in a left ventricular vein and functions appropriately. The Attain Family leads include the following models: 4193, 4194, 4195, 4196, and 4396.
Timepoint [4] 0 0
During implant procedure.
Secondary outcome [5] 0 0
Cannulation Time
Assessment method [5] 0 0
Cannulation time was defined as the time from insertion of the first coronary sinus (CS) cannulation catheter to the first successful CS cannulation.
Timepoint [5] 0 0
During implant procedure.
Secondary outcome [6] 0 0
Fluoroscopy Time
Assessment method [6] 0 0
The total time the fluoroscope was imaging (not including biplane fluoroscopy time).
Timepoint [6] 0 0
During implant procedure.
Secondary outcome [7] 0 0
Model 4396 Lead Placement Time
Assessment method [7] 0 0
Model 4396 lead placement time was defined as the time from insertion of the successfully implanted lead to the time when it was placed in the first acceptable pacing location.
Timepoint [7] 0 0
During implant procedure.
Secondary outcome [8] 0 0
Total Operation Time
Assessment method [8] 0 0
Total operation time was defined as time from initial incision to final closure.
Timepoint [8] 0 0
During implant procedure.
Secondary outcome [9] 0 0
Assessment of Lead Handling Characteristics Reported as Acceptable
Assessment method [9] 0 0
Implant lead handling characteristics were qualitatively assessed through physician feedback on the Implant Case Report Form (CRF). Physicians were asked for their overall assessment of the lead and results were categorized as acceptable or unacceptable. The number of acceptable responses are summarized.
Timepoint [9] 0 0
During implant procedure.
Secondary outcome [10] 0 0
Efficacy: Bipolar Voltage Threshold
Assessment method [10] 0 0
Subjects' voltage threshold in the bipolar configuration was collected at the one month visit. The Model 4396 was considered effective if the mean voltage threshold (at 0.5 milliseconds \[ms\]) is less than or equal to 4.0 Volts.
Timepoint [10] 0 0
1 month
Secondary outcome [11] 0 0
Characterize Model 4396 Electrical Performance- Tip Electrode: Voltage Threshold
Assessment method [11] 0 0
Tip electrode voltage threshold at 0.5 ms was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Voltage threshold values at the 6 month visit are summarized.
Timepoint [11] 0 0
6 month
Secondary outcome [12] 0 0
Characterize Model 4396 Electrical Performance- Tip Electrode: Pacing Impedance
Assessment method [12] 0 0
Subjects' tip electrode pacing impedance (a measure of electrical resistance) was measured at implant, pre-hospital discharge and all scheduled follow-up visits. Pacing impedance at the 6 month visit is presented here.
Timepoint [12] 0 0
6 month
Secondary outcome [13] 0 0
Characterize Model 4396 Electrical Performance- Tip Electrode: Sensing
Assessment method [13] 0 0
Tip electrode sensing, measured by R-wave amplitude, for the Model 4396 was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Measurements at the 6 month visit are presented here. Sensing is the minimum energy produced by the left ventricle of the heart that the device can sense.
Timepoint [13] 0 0
6 month
Secondary outcome [14] 0 0
Characterize Model 4396 Electrical Performance- Ring Electrode: Voltage Threshold
Assessment method [14] 0 0
Ring electrode voltage threshold at 0.5 ms was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Voltage threshold at the 6 month visit is presented here.
Timepoint [14] 0 0
6 month
Secondary outcome [15] 0 0
Characterize Model 4396 Electrical Performance- Ring Electrode: Pacing Impedance
Assessment method [15] 0 0
Subjects' ring electrode pacing impedance was measured at implant, pre-hospital discharge and all scheduled follow-up visits. Pacing impedance at the 6 month visit is presented here.
Timepoint [15] 0 0
6 month
Secondary outcome [16] 0 0
Characterize Model 4396 Electrical Performance- Ring Electrode: Sensing
Assessment method [16] 0 0
Ring electrode sensing, measured by R-wave amplitude, for the Model 4396 was collected only at the implant procedure because the devices allowed in this study are not programmable to collect sensing measurements using the ring electrode. The analyzer was used to collect measurements.
Timepoint [16] 0 0
During implant procedure.
Secondary outcome [17] 0 0
Characterize Model 4396 Electrical Performance- Bipolar Configuration: Voltage Threshold
Assessment method [17] 0 0
Bipolar voltage threshold at 0.5 ms was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Voltage threshold at the 6 month visit is reported here.
Timepoint [17] 0 0
6 month
Secondary outcome [18] 0 0
Characterize Model 4396 Electrical Performance- Bipolar Configuration: Pacing Impedance
Assessment method [18] 0 0
Subjects' bipolar pacing impedance was measured at implant, pre-hospital discharge and all scheduled follow-up visits. Pacing impedance at the 6 month visit is presented here.
Timepoint [18] 0 0
6 month
Secondary outcome [19] 0 0
Characterize Model 4396 Electrical Performance- Bipolar Configuration: Sensing
Assessment method [19] 0 0
Bipolar sensing, measured by R-wave amplitude, for the Model 4396 was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Measurements at the 6 month visit are presented here.
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
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00853593