Heart Failure
Conditions
Keywords
heart failure, cardiac pacing, cardiac resynchronization therapy, left ventricular lead
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. 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 trial. 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.
Interventions
DEVICEPacing Lead (Model 4296 LV Lead)
Implant and follow-up of study device
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Cardiac Resynchronization Therapy (CRT)/Cardiac Resynchronization Therapy-Defibrillator (CRT-D) indications according to the European Society of Cardiology/American College of Cardiology/American Heart Association (ESC/ACC/AHA) guidelines * On optimal medical treatment according to investigator opinion * Indicated for implantable cardioverter defibrillator (ICD) if CRT-D is implanted * Patient consent * Geographically stable
Exclusion criteria
* Left Ventricular (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 90 days * Contraindicated for transvenous pacing * Heart transplant * Contraindicated for less than 1 milligram (mg) dexamethasone acetate * Enrolled or intends to participate in concurrent drug and/or device study which would confound results * Life expectancy shorter than duration of the study *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Left Ventricular (LV)Lead Related Complications | Implant to one-month post implant | A LV lead related complication occurs when an invasive procedure is needed to correct an adverse event related to the LV lead. |
Countries
Austria, Finland, Germany, India, Italy, Netherlands, Norway, Slovakia
Participant flow
Recruitment details
The trial began with the first subject enrollment on July 1, 2009 and subsequent first implant of the Model 4296 LV lead on July 2, 2009. A total of 90 subjects were enrolled in the study of which 82 were successfully implanted with a Model 4296 LV lead. Last enrollment took place on December 16, 2009.
Participants by arm
| Arm | Count |
|---|---|
| Model 4296 LV Lead Study This study is a prospective, multi-center, non-randomized, one-arm clinical trial using Objective Performance Criteria (OPC) to evaluate the safety and efficacy of the Model 4296 LV lead. The OPC based trial design is consistent with the designs used to evaluate all current market released Medtronic left ventricular leads. The Model 4296 LV lead is designed to provide physicians with acceptable unipolar pacing from two selectable electrodes.All subjects are planned to undergo a CRT system implant and will be followed through at least pre-hospital discharge and one month visit. | 90 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Patients not implanted with 4296 lead | 8 |
Baseline characteristics
| Characteristic | Model 4296 LV Lead Study |
|---|---|
| Age, Continuous | 67.0 years STANDARD_DEVIATION 8.8 |
| Left Ventricular Ejection Fraction | 25.6 Percentage (%) STANDARD_DEVIATION 6.5 |
| New York Heart Association Functional Classification NYHA Class II | 3 participants |
| New York Heart Association Functional Classification NYHA Class III | 86 participants |
| New York Heart Association Functional Classification NYHA Class IV | 1 participants |
| QRS Duration | 159.0 milliseconds STANDARD_DEVIATION 21.1 |
| Region of Enrollment Austria | 11 participants |
| Region of Enrollment Germany | 43 participants |
| Region of Enrollment Italy | 9 participants |
| Region of Enrollment Netherlands | 14 participants |
| Region of Enrollment Norway | 3 participants |
| Region of Enrollment Slovakia | 10 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 26 / 90 |
| serious Total, serious adverse events | 16 / 90 |
Outcome results
Primary
Number of Participants With Left Ventricular (LV)Lead Related Complications
A LV lead related complication occurs when an invasive procedure is needed to correct an adverse event related to the LV lead.
Time frame: Implant to one-month post implant
Population: All subjects implanted with the lead who had completed their one-month post-implant/or a later follow-up visit, or have had a complication by the one-month post-implant visit, were included in the analysis. A complication is defined as an Adverse Event that results in death, any termination of significant device function or invasive intervention
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Model 4296 LV Lead Study | Number of Participants With Left Ventricular (LV)Lead Related Complications | 1 participants |