Congestive Heart Failure
Conditions
Keywords
Long-term safety and reliability of a bipolar left ventricular lead on congestive heart failure patients
Brief summary
The objective of this study is to confirm the long-term safety and reliability of the Corox OTW BP left ventricular (LV) pacing lead. As a condition of approval, the FDA required that a registry documenting the post approval clinical experience of these leads be designed and implemented.
Detailed description
This study is an FDA-required, multi-center, prospective, non-randomized, data collection registry. Eligible patients must have been successfully implanted with a Corox OTW BP, Corox OTW-S BP, or Corox OTW-L BP LV lead with a BIOTRONIK CRT device and consented and enrolled between 7-180 days following implant. At least 2500 patients will be enrolled in this post-approval registry, and each patient will be followed for five years post-implant. Safety will be evaluated based on the analysis of the overall incidence of lead-related adverse events that require additional invasive intervention. In addition, each individual adverse event will be separately investigated. Lead parameters for sensing, pacing thresholds, and impedance will also be evaluated. Reporting of all adverse events will be performed twice a year in order to identify and characterize any trends in adverse events, failure modes, or failure rates.
Interventions
DEVICECRT Therapy - LV Lead Registry
Collecting long-term safety and efficacy data on a market-released left ventricular lead.
Sponsors
Biotronik, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Successfully implanted BIOTRONIK CRT system, including a Corox BP LV lead, from 7-180 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 any IDE clinical study * Planned cardiac surgical procedures or interventional measures within the next 6 months * Expected to receive a heart transplant within 1 year * Life expectancy less than 1 year * Presence of another life-threatening, underlying illness separate from their cardiac disorder * Pregnancy * Inability to provide date of implant, devices implanted, age, gender, and whether the patient experienced any protocol-defined adverse events since implant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Who Are Free of Complications Related to the Corox LV Lead | 5 years | The overall incidence of serious adverse events that require additional invasive intervention to resolve, related to the Corox BP LV leads implanted with either BIOTRONIK CRT-P or CRT-D devices.This was evaluated as a serious adverse event free-rate (SAEFR). |
| Percentage of Subjects Experiencing Individual Complications | 5 years | Evaluation of the individual types of serious adverse events contributing to primary outcome 1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Corox BP LV Lead Pacing Threshold Measurements | 5 years | Pacing threshold measurements for the all Corox BP LV lead models at scheduled CELESTIAL registry through 5 years post-implant. |
| Corox BP LV Lead Sensing Measurements | 5 years | Sensing measurements for the all Corox BP LV lead models at scheduled CELESTIAL registry through 5 years post-implant. |
| Corox BP LV Lead Impedance Measurements | 5 years | Impedance measurements for the all Corox BP LV lead models at scheduled CELESTIAL registry through 5 years post-implant. |
| Pacing Threshold Measurements Per Corox BP LV Lead Model | 5 years | Pacing threshold measurements for the Corox OTW BP LV lead, the Corox OTW-S BP LV lead, and the Corox OTW-L BP LV lead. |
| Mean Successful Biventricular Pacing in Subjects at the 5 Year In-office Visit. | 5 years | Successful biventricular pacing in a BIOTRONIK CRT device at scheduled CELESTIAL registry follow-up visits through 5 years post-implant. |
| Impedance Measurements Per Corox BP LV Lead Model | 5 years | Impedance measurements for the Corox OTW BP LV lead, the Corox OTW-S BP LV lead, and the Corox OTW-L BP LV lead. |
| Overall Incidence of Primary Endpoint 1 Serious Adverse Events for Each Corox BP Lead Model | 5 years | Overall incidence of serious adverse events that meet the primary endpoint 1 criteria will be evaluated separately for each Corox BP lead model. |
| Incidence of Individual Types of Primary Endpoint 2 Adverse Events Will be Evaluated Separately for Each Corox BP Lead Model | 5 years | Incidence of individual types of serious adverse events contributing to primary endpoint 2 will be evaluated separately for each Corox BP lead model. |
| Sensing Measurements Per Corox BP LV Lead Model | 5 years | Sensing measurements for the Corox OTW BP LV lead, the Corox OTW-S BP LV lead, and the Corox OTW-L BP LV lead. |
| Percentage of Subjects Experiencing Serious Adverse Event Excluded From Primary Safety Endpoint | 5 years | Serious adverse event rates for SAEs excluded from primary safety endpoint through 5 years post-implant. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BIOTRONIK Corox BP LV Lead Subjects consented and implanted with a BIOTRONIK Corox BP LV lead. | 2,498 |
| Total | 2,498 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 641 |
| Overall Study | Lost to Follow-up | 191 |
| Overall Study | Withdrawal by subject or physician | 721 |
Baseline characteristics
| Characteristic | BIOTRONIK Corox BP LV Lead |
|---|---|
| Age, Continuous | 70.4 years STANDARD_DEVIATION 11.4 |
| Height | 67.7 inches STANDARD_DEVIATION 4.2 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 4 Participants |
| Race/Ethnicity, Customized Asian | 36 Participants |
| Race/Ethnicity, Customized Black or African American | 220 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 244 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 7 Participants |
| Race/Ethnicity, Customized Not Reported | 117 Participants |
| Race/Ethnicity, Customized Unknown | 65 Participants |
| Race/Ethnicity, Customized White | 1805 Participants |
| Sex: Female, Male Female | 724 Participants |
| Sex: Female, Male Male | 1774 Participants |
| Weight | 194.4 pounds STANDARD_DEVIATION 48.1 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 641 / 2,499 |
| other Total, other adverse events | 83 / 2,499 |
| serious Total, serious adverse events | 281 / 2,499 |
Outcome results
Primary
Percentage of Subjects Experiencing Individual Complications
Evaluation of the individual types of serious adverse events contributing to primary outcome 1.
Time frame: 5 years
Population: The evaluable subject population is the sum of the total unique subjects who completed the 5-year follow-up and/or who experienced a primary endpoint adverse event.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BIOTRONIK Corox BP LV Lead | Percentage of Subjects Experiencing Individual Complications | Lead dislodgement (>180 days post-implant) | 3.28 percentage of subjects |
| BIOTRONIK Corox BP LV Lead | Percentage of Subjects Experiencing Individual Complications | Abnormal pacing impedance | 1.90 percentage of subjects |
| BIOTRONIK Corox BP LV Lead | Percentage of Subjects Experiencing Individual Complications | Conductor fracture | 0.53 percentage of subjects |
| BIOTRONIK Corox BP LV Lead | Percentage of Subjects Experiencing Individual Complications | Malposition, excess slack | 0.11 percentage of subjects |
Primary
Percentage of Subjects Who Are Free of Complications Related to the Corox LV Lead
The overall incidence of serious adverse events that require additional invasive intervention to resolve, related to the Corox BP LV leads implanted with either BIOTRONIK CRT-P or CRT-D devices.This was evaluated as a serious adverse event free-rate (SAEFR).
Time frame: 5 years
Population: The evaluable subject population is the sum of the total unique subjects who completed the 5-year follow-up and/or who experienced a primary endpoint adverse event.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BIOTRONIK Corox BP LV Lead | Percentage of Subjects Who Are Free of Complications Related to the Corox LV Lead | 94.19 percentage of subjects |
p-value: <0.0001Binomial Proportion
Secondary
Corox BP LV Lead Impedance Measurements
Impedance measurements for the all Corox BP LV lead models at scheduled CELESTIAL registry through 5 years post-implant.
Time frame: 5 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIOTRONIK Corox BP LV Lead | Corox BP LV Lead Impedance Measurements | 726.5 ohms | Standard Deviation 250.9 |
Secondary
Corox BP LV Lead Pacing Threshold Measurements
Pacing threshold measurements for the all Corox BP LV lead models at scheduled CELESTIAL registry through 5 years post-implant.
Time frame: 5 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIOTRONIK Corox BP LV Lead | Corox BP LV Lead Pacing Threshold Measurements | 1.41 V | Standard Deviation 1.09 |
Secondary
Corox BP LV Lead Sensing Measurements
Sensing measurements for the all Corox BP LV lead models at scheduled CELESTIAL registry through 5 years post-implant.
Time frame: 5 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIOTRONIK Corox BP LV Lead | Corox BP LV Lead Sensing Measurements | 13.94 mV | Standard Deviation 7.51 |
Secondary
Impedance Measurements Per Corox BP LV Lead Model
Impedance measurements for the Corox OTW BP LV lead, the Corox OTW-S BP LV lead, and the Corox OTW-L BP LV lead.
Time frame: 5 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIOTRONIK Corox BP LV Lead | Impedance Measurements Per Corox BP LV Lead Model | 730.3 ohms | Standard Deviation 264.9 |
| Corox OTW-S BP | Impedance Measurements Per Corox BP LV Lead Model | 734.4 ohms | Standard Deviation 251.7 |
| Corox OTW-L BP | Impedance Measurements Per Corox BP LV Lead Model | 709.2 ohms | Standard Deviation 233.1 |
Secondary
Incidence of Individual Types of Primary Endpoint 2 Adverse Events Will be Evaluated Separately for Each Corox BP Lead Model
Incidence of individual types of serious adverse events contributing to primary endpoint 2 will be evaluated separately for each Corox BP lead model.
Time frame: 5 years
Population: The evaluable subject population for each group is the sum of the total unique subjects who completed the 5-year follow-up and/or who experienced a primary endpoint adverse event in the group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BIOTRONIK Corox BP LV Lead | Incidence of Individual Types of Primary Endpoint 2 Adverse Events Will be Evaluated Separately for Each Corox BP Lead Model | Conductor fracture | 1.79 percentage of subjects |
| BIOTRONIK Corox BP LV Lead | Incidence of Individual Types of Primary Endpoint 2 Adverse Events Will be Evaluated Separately for Each Corox BP Lead Model | Lead dislodgement (>180 days post-implant) | 3.58 percentage of subjects |
| BIOTRONIK Corox BP LV Lead | Incidence of Individual Types of Primary Endpoint 2 Adverse Events Will be Evaluated Separately for Each Corox BP Lead Model | Malposition, excess slack | 0 percentage of subjects |
| BIOTRONIK Corox BP LV Lead | Incidence of Individual Types of Primary Endpoint 2 Adverse Events Will be Evaluated Separately for Each Corox BP Lead Model | Abnormal pacing impedance | 1.79 percentage of subjects |
| Corox OTW-S BP | Incidence of Individual Types of Primary Endpoint 2 Adverse Events Will be Evaluated Separately for Each Corox BP Lead Model | Conductor fracture | 0 percentage of subjects |
| Corox OTW-S BP | Incidence of Individual Types of Primary Endpoint 2 Adverse Events Will be Evaluated Separately for Each Corox BP Lead Model | Abnormal pacing impedance | 2.99 percentage of subjects |
| Corox OTW-S BP | Incidence of Individual Types of Primary Endpoint 2 Adverse Events Will be Evaluated Separately for Each Corox BP Lead Model | Lead dislodgement (>180 days post-implant) | 3.49 percentage of subjects |
| Corox OTW-S BP | Incidence of Individual Types of Primary Endpoint 2 Adverse Events Will be Evaluated Separately for Each Corox BP Lead Model | Malposition, excess slack | 0 percentage of subjects |
| Corox OTW-L BP | Incidence of Individual Types of Primary Endpoint 2 Adverse Events Will be Evaluated Separately for Each Corox BP Lead Model | Abnormal pacing impedance | 0.38 percentage of subjects |
| Corox OTW-L BP | Incidence of Individual Types of Primary Endpoint 2 Adverse Events Will be Evaluated Separately for Each Corox BP Lead Model | Lead dislodgement (>180 days post-implant) | 2.63 percentage of subjects |
| Corox OTW-L BP | Incidence of Individual Types of Primary Endpoint 2 Adverse Events Will be Evaluated Separately for Each Corox BP Lead Model | Malposition, excess slack | 0.38 percentage of subjects |
| Corox OTW-L BP | Incidence of Individual Types of Primary Endpoint 2 Adverse Events Will be Evaluated Separately for Each Corox BP Lead Model | Conductor fracture | 0 percentage of subjects |
Secondary
Mean Successful Biventricular Pacing in Subjects at the 5 Year In-office Visit.
Successful biventricular pacing in a BIOTRONIK CRT device at scheduled CELESTIAL registry follow-up visits through 5 years post-implant.
Time frame: 5 years
Population: The subjects analyzed in this outcome must have been consented, implanted with a BIOTRONIK Corox BP LV lead, and completed an in-office 5 year visit. Subjects who did not complete an in-office 5 year visit are excluded from this analysis population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIOTRONIK Corox BP LV Lead | Mean Successful Biventricular Pacing in Subjects at the 5 Year In-office Visit. | 97.4 percentage of CRT pacing | Standard Deviation 8.4 |
Secondary
Overall Incidence of Primary Endpoint 1 Serious Adverse Events for Each Corox BP Lead Model
Overall incidence of serious adverse events that meet the primary endpoint 1 criteria will be evaluated separately for each Corox BP lead model.
Time frame: 5 years
Population: The evaluable subject population for each group is the sum of the total unique subjects who completed the 5-year follow-up and/or who experienced a primary endpoint adverse event in the group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BIOTRONIK Corox BP LV Lead | Overall Incidence of Primary Endpoint 1 Serious Adverse Events for Each Corox BP Lead Model | 7.17 percentage of subjects |
| Corox OTW-S BP | Overall Incidence of Primary Endpoint 1 Serious Adverse Events for Each Corox BP Lead Model | 6.48 percentage of subjects |
| Corox OTW-L BP | Overall Incidence of Primary Endpoint 1 Serious Adverse Events for Each Corox BP Lead Model | 3.38 percentage of subjects |
Secondary
Pacing Threshold Measurements Per Corox BP LV Lead Model
Pacing threshold measurements for the Corox OTW BP LV lead, the Corox OTW-S BP LV lead, and the Corox OTW-L BP LV lead.
Time frame: 5 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIOTRONIK Corox BP LV Lead | Pacing Threshold Measurements Per Corox BP LV Lead Model | 1.30 V | Standard Deviation 1.01 |
| Corox OTW-S BP | Pacing Threshold Measurements Per Corox BP LV Lead Model | 1.40 V | Standard Deviation 1.09 |
| Corox OTW-L BP | Pacing Threshold Measurements Per Corox BP LV Lead Model | 1.53 V | Standard Deviation 1.17 |
Secondary
Percentage of Subjects Experiencing Serious Adverse Event Excluded From Primary Safety Endpoint
Serious adverse event rates for SAEs excluded from primary safety endpoint through 5 years post-implant.
Time frame: 5 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BIOTRONIK Corox BP LV Lead | Percentage of Subjects Experiencing Serious Adverse Event Excluded From Primary Safety Endpoint | LV lead cardiac perforation | 0.04 Percent of subjects |
| BIOTRONIK Corox BP LV Lead | Percentage of Subjects Experiencing Serious Adverse Event Excluded From Primary Safety Endpoint | LV lead high pacing threshold, no lead capture | 0.96 Percent of subjects |
| BIOTRONIK Corox BP LV Lead | Percentage of Subjects Experiencing Serious Adverse Event Excluded From Primary Safety Endpoint | LV lead diaphragmatic / pectoral stimulation | 1.00 Percent of subjects |
| BIOTRONIK Corox BP LV Lead | Percentage of Subjects Experiencing Serious Adverse Event Excluded From Primary Safety Endpoint | LV lead dislodgement (<180 days post-implant) | 1.64 Percent of subjects |
| BIOTRONIK Corox BP LV Lead | Percentage of Subjects Experiencing Serious Adverse Event Excluded From Primary Safety Endpoint | RV pacing lead related adverse event | 0.16 Percent of subjects |
| BIOTRONIK Corox BP LV Lead | Percentage of Subjects Experiencing Serious Adverse Event Excluded From Primary Safety Endpoint | Device related adverse event | 0.28 Percent of subjects |
| BIOTRONIK Corox BP LV Lead | Percentage of Subjects Experiencing Serious Adverse Event Excluded From Primary Safety Endpoint | Other adverse event | 1.36 Percent of subjects |
| BIOTRONIK Corox BP LV Lead | Percentage of Subjects Experiencing Serious Adverse Event Excluded From Primary Safety Endpoint | RA lead related adverse event | 2.08 Percent of subjects |
| BIOTRONIK Corox BP LV Lead | Percentage of Subjects Experiencing Serious Adverse Event Excluded From Primary Safety Endpoint | Implant procedure related adverse event | 3.20 Percent of subjects |
| BIOTRONIK Corox BP LV Lead | Percentage of Subjects Experiencing Serious Adverse Event Excluded From Primary Safety Endpoint | ICD lead related adverse event | 3.96 Percent of subjects |
| BIOTRONIK Corox BP LV Lead | Percentage of Subjects Experiencing Serious Adverse Event Excluded From Primary Safety Endpoint | Other high pacing threshold | 0.04 Percent of subjects |
Secondary
Sensing Measurements Per Corox BP LV Lead Model
Sensing measurements for the Corox OTW BP LV lead, the Corox OTW-S BP LV lead, and the Corox OTW-L BP LV lead.
Time frame: 5 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIOTRONIK Corox BP LV Lead | Sensing Measurements Per Corox BP LV Lead Model | 14.82 mV | Standard Deviation 7.74 |
| Corox OTW-S BP | Sensing Measurements Per Corox BP LV Lead Model | 13.94 mV | Standard Deviation 7.59 |
| Corox OTW-L BP | Sensing Measurements Per Corox BP LV Lead Model | 13.04 mV | Standard Deviation 7.02 |