Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corox OTW Steroid Left Ventricular Lead | Device | This is a registry: no study required interventions necessary. |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term Effectiveness of the COROX Over-the-wire (OTW) Steroid in Providing Biventricular Pacing | Evaluate threshold voltage of the COROX OTW Unipolar Lead. | All follow-ups for 3 years post implant |
| Safety of the COROX OTW Steroid LV Pacing Lead | Number of participants with LV lead related adverse events requiring additional invasive intervention to resolve. | 3 years post implant |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Katerina de Metz | Biotronik, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biotronik | Lake Oswego | Oregon | 97035 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Corox OTW Unipolar Lead | Study Participants followed for three years post implant. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Corox OTW Unipolar Lead | Study Participants followed for three years post implant. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All study participants. | Posted | Mean | Standard Deviation | Threshold Voltage | All follow-ups for 3 years post implant | LV Lead Threshold Tests | Participants |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| High LV Lead Threshold | Cardiac disorders | Systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Studies | Biotronik, Inc. | 503-451-8050 | katerina.demetz@biotronik.com |
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Study device explanted |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| LV Lead Threshold Tests |
|
|
| 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. | All study participants. | Posted | Number | participants | 3 years post implant |
|
|
|
| 9 |
| 221 |
| 0 |
| 221 |
| Infection | Surgical and medical procedures | Systematic Assessment |
|
| LV Lead Dislodgement | Cardiac disorders | Systematic Assessment |
|
| Lead Integrity Comprimised noted at Device Change-Out | Surgical and medical procedures | Systematic Assessment |
|
| Phrenic Nerve Stimulation | Cardiac disorders | Systematic Assessment |
|
Not provided