Heart Failure, Inappropriate Phrenic Nerve Stimulation, Left Ventricular Cardiac Dysfunction, Perioperative/Postoperative Complications, Postoperative Cardiac Complication
Conditions
Keywords
Cardiac Resynchronization therapy,, Heart Failure,, Left Ventricular Lead,, Quadripolar Left ventricular Lead,, Phrenic Nerve Stimulation,, Intra and post operative related complications
Brief summary
This investigation is designed with the hypothesis that using a quadripolar left ventricular lead results in less interventions when dealing with high pacing thresholds and Phrenic Nerve Stimulation (PNS), both at implant and during follow-up, compared to standard bipolar left ventricular leads.
Interventions
PROCEDUREBiP Group
Implantation of standard Left Ventricular (LV) lead
DEVICEQuad Group
Implantation of quadripolar Left ventricular (LV) lead Quartet
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients are indicated for Cardiac Resynchronization Therapy with Defibrillation backup device (CRT-D) implantation, as per current international certified guidelines * Patients age is 18 years or greater * Patients must indicate their understanding of the study and willingness to participate by signing the appropriate informed consent form * Patients must be willing and able to comply with all study requirements
Exclusion criteria
* Patients with a life expectancy \<12 months. * Patients who are or may potentially be pregnant. * Patient has suffered any of the following in the 4 weeks prior to enrolment: * Myocardial Infarction (MI) * Coronary Artery Bypass Graft (CABG) * Unstable Angina Pectoris * Patient has primary valvular disease which has not been corrected
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lead Performance | 6 months | Percentage of patients with freedom from event (intra- and post-operative). Intra-operative events were defined as: need to use more than 1 left ventricular lead, need to change lead implant position, use of any device to actively fixate the lead, unsuccessful implant, due to phrenic nerve stimulation, high pacing threshold or lead instability. Post-operative events were defined as any left ventricular lead related serious adverse device effect and CRT switched off. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Cardiac Resynchronization Therapy Responders | Baseline and 6 months | Percentage of Cardiac Resynchronization Therapy (CRT) responders measured by a decrease of at least 10% of Left Ventricle End-Systolic Volume (LVESV) |
| Implant Duration | Total duration of the implant procedure reported at the end of the procedure | This measure reports the length (in time) of the implantation procedure. The measurement start at skin incision and stop at skin suture (so called skin-to-skin time) The total implant procedure duration time will be compared between the control and the treatment group. |
Countries
Belgium, Canada, Finland, France, Germany, India, Israel, Italy, Netherlands, Poland, Spain, Switzerland, United Kingdom
Participant flow
Pre-assignment details
1078 patients have been enrolled in this study, while 1074 have been randomized to Quad or BiP group. The randomization procedure happened after the enrollment and before the implant, this explains why not all 1078 patients have been randomized
Participants by arm
| Arm | Count |
|---|---|
| Quad Group Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet
Quartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet | 718 |
| BiP Group Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)
Standard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead | 348 |
| Total | 1,066 |
Baseline characteristics
| Characteristic | Quad Group | BiP Group | Total |
|---|---|---|---|
| Age, Continuous | 67.6 years STANDARD_DEVIATION 10.2 | 68.4 years STANDARD_DEVIATION 9.7 | 67.9 years STANDARD_DEVIATION 10.1 |
| Atrial Arrhythmia History Atrial Fibrillation | 114 participants | 58 participants | 172 participants |
| Atrial Arrhythmia History Atrial Flutter | 21 participants | 7 participants | 28 participants |
| Atrial Arrhythmia History None | 583 participants | 283 participants | 866 participants |
| Cardiomyopathy Ischemic | 353 participants | 196 participants | 549 participants |
| Cardiomyopathy Non Ischemic | 365 participants | 152 participants | 517 participants |
| Left Ventricular Ejection Fraction (LVEF) | 27.1 % STANDARD_DEVIATION 7.6 | 27.5 % STANDARD_DEVIATION 8.1 | 27.2 % STANDARD_DEVIATION 7.7 |
| Left Ventricular End-Diastolic Volume (LVEDV) | 200.4 ml STANDARD_DEVIATION 74.9 | 204.5 ml STANDARD_DEVIATION 72 | 203.2 ml STANDARD_DEVIATION 80.6 |
| Left Ventricular End-Systolic Volume (LVESV) | 151.2 ml STANDARD_DEVIATION 64 | 149.0 ml STANDARD_DEVIATION 58.3 | 150.5 ml STANDARD_DEVIATION 62.2 |
| QRS duration | 158 ms STANDARD_DEVIATION 29 | 157 ms STANDARD_DEVIATION 27 | 157.5 ms STANDARD_DEVIATION 28.4 |
| Sex: Female, Male Female | 173 Participants | 74 Participants | 247 Participants |
| Sex: Female, Male Male | 545 Participants | 274 Participants | 819 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 186 / 719 | 76 / 355 |
| serious Total, serious adverse events | 332 / 719 | 211 / 355 |
Outcome results
Primary
Lead Performance
Percentage of patients with freedom from event (intra- and post-operative). Intra-operative events were defined as: need to use more than 1 left ventricular lead, need to change lead implant position, use of any device to actively fixate the lead, unsuccessful implant, due to phrenic nerve stimulation, high pacing threshold or lead instability. Post-operative events were defined as any left ventricular lead related serious adverse device effect and CRT switched off.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Quad Group | Lead Performance | 83 % of patients with freedom from event |
| BiP Group | Lead Performance | 74.4 % of patients with freedom from event |
Secondary
Implant Duration
This measure reports the length (in time) of the implantation procedure. The measurement start at skin incision and stop at skin suture (so called skin-to-skin time) The total implant procedure duration time will be compared between the control and the treatment group.
Time frame: Total duration of the implant procedure reported at the end of the procedure
Population: The number of participants analyzed is the number of patients with implant data duration time available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quad Group | Implant Duration | 100.4 min | Standard Deviation 54.5 |
| BiP Group | Implant Duration | 101.1 min | Standard Deviation 51 |
Secondary
Percentage of Cardiac Resynchronization Therapy Responders
Percentage of Cardiac Resynchronization Therapy (CRT) responders measured by a decrease of at least 10% of Left Ventricle End-Systolic Volume (LVESV)
Time frame: Baseline and 6 months
Population: The number of participants analyzed is the number of patients with echo data received for both baseline and 6 months follow up visits (and so comparable)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Quad Group | Percentage of Cardiac Resynchronization Therapy Responders | 62.0 % of patients that are CRT responders |
| BiP Group | Percentage of Cardiac Resynchronization Therapy Responders | 56.0 % of patients that are CRT responders |