Congestive Heart Failure
Conditions
Keywords
Congestive Heart Failure, Cardiac Resynchronization Therapy, Left Ventricular Lead
Brief summary
The objective of this post approval registry is to confirm the long-term safety and effectiveness of the Corox Over-the-wire (OTW) Steroid Left Ventricular (LV) lead as used in conjunction with a BIOTRONK cardiac resynchronization therapy defibrillator (CRT-D). The Corox OTW Steroid LV Lead is capable of providing permanent pacing therapy to the left ventricle in a CRT-D system. The following are the specific objectives to be evaluated during this post-approval registry: * Long-term effectiveness of the COROX OTW Steroid in providing biventricular pacing * Safety of the COROX OTW Steroid LV pacing lead
Detailed description
This post approval registry enrolled 221 patients from 34 centers. The collection of registry data continued for three years for each enrolled subject. Potential patients were screened by the enrolling physician according to the detailed inclusion and exclusion criteria below. The specific required visits for this registry are: Enrollment, Three-month, Six month, One-year, Routine Follow-Ups (every subsequent 6 months), Interim follow-ups for Corox OTW Steroid LV lead related visits, and Out of Service visit. Data will be collected at each patient follow-up. The programmed pacing parameters, LV pacing impedance, and LV pacing threshold measurement at 0.5ms pulse width will be obtained. The programming parameters will be set to best suit each patient. If adequate system function, including effective CRT, cannot be obtained, the patient should not be selected for the registry.
Interventions
DEVICECorox OTW Steroid Left Ventricular Lead
This is a registry: no study required interventions necessary.
Sponsors
Biotronik, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Successfully implanted BIOTRONIK CRT-D system, including the Corox OTW Steroid LV Lead, from 1-30 days prior to enrollment * Able to understand the nature of the registry and give informed consent * Available for follow-up visits on a regular basis at the investigational site * Age greater than or equal to 18 years
Exclusion criteria
* Enrolled in another cardiovascular or pharmacological clinical investigation * Planned cardiac surgical procedures or interventional measures within the next 6 months * Expected to receive a heart transplant within 6 months * Life expectancy less than 6 months * Presence of another life-threatening, underlying illness separate from their cardiac disorder * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Long-term Effectiveness of the COROX Over-the-wire (OTW) Steroid in Providing Biventricular Pacing | All follow-ups for 3 years post implant | Evaluate threshold voltage of the COROX OTW Unipolar Lead. |
| Safety of the COROX OTW Steroid LV Pacing Lead | 3 years post implant | Number of participants with LV lead related adverse events requiring additional invasive intervention to resolve. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Corox OTW Unipolar Lead Study Participants followed for three years post implant. | 221 |
| Total | 221 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 43 |
| Overall Study | Lost to Follow-up | 15 |
| Overall Study | Study device explanted | 8 |
| Overall Study | Withdrawal by Subject | 59 |
Baseline characteristics
| Characteristic | Corox OTW Unipolar Lead |
|---|---|
| Age Continuous | 67.3 years STANDARD_DEVIATION 11.8 |
| Region of Enrollment United States | 221 participants |
| Sex: Female, Male Female | 53 Participants |
| Sex: Female, Male Male | 168 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 221 |
| serious Total, serious adverse events | 9 / 221 |
Outcome results
Primary
Long-term Effectiveness of the COROX Over-the-wire (OTW) Steroid in Providing Biventricular Pacing
Evaluate threshold voltage of the COROX OTW Unipolar Lead.
Time frame: All follow-ups for 3 years post implant
Population: All study participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Corox OTW Unipolar Lead | Long-term Effectiveness of the COROX Over-the-wire (OTW) Steroid in Providing Biventricular Pacing | 1.3 Threshold Voltage | Standard Deviation 1.1 |
Primary
Safety of the COROX OTW Steroid LV Pacing Lead
Number of participants with LV lead related adverse events requiring additional invasive intervention to resolve.
Time frame: 3 years post implant
Population: All study participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Corox OTW Unipolar Lead | Safety of the COROX OTW Steroid LV Pacing Lead | 9 participants |