Heart Failure4396NCT00853593
Model 4396 Left Ventricular (LV) Lead Study
A study testing Pacing Lead in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 31 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Pacing Lead
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 31 sitesin 8 countries
- Study dates
- Mar 2009to Aug 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
31 sites in 8 countries.
31 sites in 8 countries
United States19 sites
Study site
Atlanta, Georgia
Study site
Atlantis, Florida
Study site
Austin, Texas
Study site
Baton Rouge, Louisiana
Study site
Davenport, Iowa
Study site
Durham, North Carolina
Study site
Hinsdale, Illinois
Study site
Kansas City, Kansas
Study site
Lexington, Kentucky
Study site
Liverpool, New York
Study site
Morgantown, West Virginia
Study site
Nashville, Tennessee
Study site
New York, New York
Study site
Pasadena, California
Study site
Portland, Oregon
Study site
Sacramento, California
Study site
Saint Louis Park, Minnesota
Study site
Saint Paul, Minnesota
Study site
York, Pennsylvania
Canada5 sites
Study site
Calgary, Alberta
Study site
Montreal, Quebec
Study site
Newmarket, Ontario
Study site
Québec, Quebec
Study site
Vancouver, British Columbia
About this study
Official title: Model 4396 Left Ventricular Lead Study
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.
Read the detailed description
This study is a prospective, multi-center, non-randomized design. All consented patients who meet all inclusion and no exclusion criteria may receive the investigational lead. The study design has statistical power to show safety at one-month after implant. It also has statistical power to show effectiveness at one-month and three-months after implant.
- Conditions
- Heart Failure
- Being tested
- Pacing Lead
- Keywords
- heart failure, cardiac pacing, cardiac resynchronization therapy, left ventricular lead
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacing LeadDevice
implant and follow-up of study device
| Study group | Role | What they receive |
|---|---|---|
| Model 4396 LV Lead | Experimental | Non-randomized study. Receives: Device: Pacing Lead |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (Subjects Without a Model 4396 Lead Related Complication)
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).
Measured: One month
Efficacy: Distal Tip Electrode Voltage Threshold
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.
Measured: One month
Efficacy: Proximal Ring Voltage Threshold
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.
Measured: Three months
Secondary outcomes (19)
Subjects Successfully Implanted With Model 4396 Lead
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.
Measured: During implant procedure.
Subjects Successfully Implanted With Any Transvenous LV Lead After Cannulation
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.
Measured: During implant procedure.
Subjects Successfully Implanted With Any Transvenous LV Lead
A successful implant occurs when any transvenous LV lead is implanted in a left ventricular vein functions appropriately.
Measured: During implant procedure.
Subjects Successfully Implanted With Any Medtronic Attain Family LV Lead
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.
Measured: During implant procedure.
Cannulation Time
Cannulation time was defined as the time from insertion of the first coronary sinus (CS) cannulation catheter to the first successful CS cannulation.
Measured: During implant procedure.
Fluoroscopy Time
The total time the fluoroscope was imaging (not including biplane fluoroscopy time).
Measured: During implant procedure.
Model 4396 Lead Placement Time
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.
Measured: During implant procedure.
Total Operation Time
Total operation time was defined as time from initial incision to final closure.
Measured: During implant procedure.
Assessment of Lead Handling Characteristics Reported as Acceptable
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.
Measured: During implant procedure.
Efficacy: Bipolar Voltage Threshold
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.
Measured: 1 month
Characterize Model 4396 Electrical Performance- Tip Electrode: Voltage Threshold
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.
Measured: 6 month
Characterize Model 4396 Electrical Performance- Tip Electrode: Pacing Impedance
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.
Measured: 6 month
Characterize Model 4396 Electrical Performance- Tip Electrode: Sensing
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.
Measured: 6 month
Characterize Model 4396 Electrical Performance- Ring Electrode: Voltage Threshold
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.
Measured: 6 month
Characterize Model 4396 Electrical Performance- Ring Electrode: Pacing Impedance
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.
Measured: 6 month
Characterize Model 4396 Electrical Performance- Ring Electrode: Sensing
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.
Measured: During implant procedure.
Characterize Model 4396 Electrical Performance- Bipolar Configuration: Voltage Threshold
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.
Measured: 6 month
Characterize Model 4396 Electrical Performance- Bipolar Configuration: Pacing Impedance
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.
Measured: 6 month
Characterize Model 4396 Electrical Performance- Bipolar Configuration: Sensing
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.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionJul 2009
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Derek Exner, MD, Principal investigator, Foothills Hospital (University of Calgary)Daniel Gras, MD, Principal investigator, Nouvelles Cliniques Nantaises
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00853593
- Sponsor's protocol ID
- 116
- Acronym
- 4396
- Status last verified
- Jan 2019
- First submitted
- 26 Feb 2009
- Last updated
- 18 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Model 4396 Left Ventricular Lead Study
- ClinicalTrials.gov ID
- NCT00853593
- Acronym / sponsor ID
- 4396 / 116
- Conditions
- Heart Failure
- Keywords
- heart failure, cardiac pacing, cardiac resynchronization therapy, left ventricular lead
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 2 Mar 2009 (estimated)
- Results
- Posted 5 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a prospective, multi-center, non-randomized design. All consented patients who meet all inclusion and no exclusion criteria may receive the investigational lead. The study design has statistical power to show safety at one-month after implant. It also has statistical power to show effectiveness at one-month and three-months after implant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Model 4396 LV Lead | Experimental | Device: Pacing LeadNon-randomized study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pacing Leadimplant and follow-up of study device | Device | Model 4396 LV Lead |
Primary outcome
Safety (Subjects Without a Model 4396 Lead Related Complication)
Time frame: One month
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).
Efficacy: Distal Tip Electrode Voltage Threshold
Time frame: One month
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.
Efficacy: Proximal Ring Voltage Threshold
Time frame: Three months
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.
19 secondary outcomes
Subjects Successfully Implanted With Model 4396 Lead
Time frame: During implant procedure.
Subjects Successfully Implanted With Any Transvenous LV Lead After Cannulation
Time frame: During implant procedure.
Subjects Successfully Implanted With Any Transvenous LV Lead
Time frame: During implant procedure.
Subjects Successfully Implanted With Any Medtronic Attain Family LV Lead
Time frame: During implant procedure.
Cannulation Time
Time frame: During implant procedure.
Fluoroscopy Time
Time frame: During implant procedure.
Model 4396 Lead Placement Time
Time frame: During implant procedure.
Total Operation Time
Time frame: During implant procedure.
Assessment of Lead Handling Characteristics Reported as Acceptable
Time frame: During implant procedure.
Efficacy: Bipolar Voltage Threshold
Time frame: 1 month
Characterize Model 4396 Electrical Performance- Tip Electrode: Voltage Threshold
Time frame: 6 month
Characterize Model 4396 Electrical Performance- Tip Electrode: Pacing Impedance
Time frame: 6 month
Characterize Model 4396 Electrical Performance- Tip Electrode: Sensing
Time frame: 6 month
Characterize Model 4396 Electrical Performance- Ring Electrode: Voltage Threshold
Time frame: 6 month
Characterize Model 4396 Electrical Performance- Ring Electrode: Pacing Impedance
Time frame: 6 month
Characterize Model 4396 Electrical Performance- Ring Electrode: Sensing
Time frame: During implant procedure.
Characterize Model 4396 Electrical Performance- Bipolar Configuration: Voltage Threshold
Time frame: 6 month
Characterize Model 4396 Electrical Performance- Bipolar Configuration: Pacing Impedance
Time frame: 6 month
Characterize Model 4396 Electrical Performance- Bipolar Configuration: Sensing
Time frame: 6 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derek Exner, MD principal investigator
Foothills Hospital (University of Calgary)
Daniel Gras, MD principal investigator
Nouvelles Cliniques Nantaises
31 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pacing Lead in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 31 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Canada, France, Australia, Austria and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (Subjects Without a Model 4396 Lead Related Complication) (time frame: One month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2019.