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Evaluation of ACUITY™ X4 Quadripolar Coronary Venous Leads and RELIANCE™ 4-FRONT Defibrillation Leads
NA trial testing ACUITY X4 quadripolar coronary venous lead and RELIANCE 4-FRONT defibrillation lead in Cardiac Resynchronization Therapy in 2,244 participants. Completed in 6 October 2020.
| Lead sponsor | Boston Scientific Corporation |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 2,244 |
| Start date | 14 April 2014 |
| Primary completion | 19 April 2017 |
| Estimated completion | 6 October 2020 |
| Sites | 96 locations across United States |
Boston Scientific Corporation — full company profile →
18 and older, any sex, with Cardiac Resynchronization Therapy. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Lead-related complication-free rate of ACUITY X4 Spiral Leads from implant through 6 months post implant.
| Group | Value | 95% CI |
|---|---|---|
| NAVIGATE X4 Study Participants | 98.5 | 97.0 – NA |
Lead-related complication-free rate of ACUITY X4 Straight Leads from implant through 6 months post implant.
| Group | Value | 95% CI |
|---|---|---|
| NAVIGATE X4 Study Participants | 96.5 | 93.8 – NA |
PCT measurements in the programmed configuration were collected at 3 months post-implant. Programmed configuration refers to the pacing configuration that was selected by the physician to provide LV pacing therapy. The percentage of measurements with PCT ≤ 2.5 V were calculated.
| Group | Value | 95% CI |
|---|---|---|
| NAVIGATE X4 Study Participants | 94.0 | 92.0 – NA |
PCT measurements in the in the proximal zone (electrodes 2, 3, 4) were collected at 3 months post-implant. Physician investigators were instructed to use the best proximal electrode (E2, E3 or E4) as the cathode and the RV lead coil or pulse generator as the anode; best was defined as the electrode with the lowest PCT without phrenic nerve stimulation. The percentage of measurements with PCT ≤ 2.5 V were calculated.
| Group | Value | 95% CI |
|---|---|---|
| NAVIGATE X4 Study Participants | 91.1 | 88.2 – NA |
Lead-related complication-free rate of RELIANCE 4-FRONT Leads from implant through 3 months post implant.
| Group | Value | 95% CI |
|---|---|---|
| NAVIGATE X4 Study Participants | 98.2 | 97.5 – NA |
Lead-related complication-free rate of RELIANCE 4-FRONT Leads from 3 through 24 months post implant.
| Group | Value | 95% CI |
|---|---|---|
| NAVIGATE X4 Study Participants | 99.3 | 98.8 – NA |
PCT measurements from RELIANCE 4-FRONT leads were collected at 3 months post-implant. Measurements were performed using 0.5 millisecond pulse width.
| Group | Value | 95% CI |
|---|---|---|
| NAVIGATE X4 Study Participants | 0.56 | NA – 0.58 |
Sensed amplitude measurements from ACUITY X4 Spiral leads were collected at 3 months post-implant.
| Group | Value | 95% CI |
|---|---|---|
| NAVIGATE X4 Study Participants | 17.4 | 16.7 – NA |
Sensed amplitude measurements from ACUITY X4 Straight leads were collected at 3 months post-implant.
| Group | Value | 95% CI |
|---|---|---|
| NAVIGATE X4 Study Participants | 16.1 | 15.1 – NA |
Pacing impedance measurements from ACUITY X4 Spiral leads were collected at 3 months post-implant.
| Group | Value | 95% CI |
|---|---|---|
| NAVIGATE X4 Study Participants | 776 | 753 – NA |
Pacing impedance measurements from ACUITY X4 Straight leads were collected at 3 months post-implant.
| Group | Value | 95% CI |
|---|---|---|
| NAVIGATE X4 Study Participants | 805 | 763 – NA |
The mean detection time, in seconds, of induced VT/VF episodes occurring within 30 days of implant were evaluated. Subjects were required to implanted with RELIANCE 4-FRONT leads to be evaluated.
| Group | Value | 95% CI |
|---|---|---|
| NAVIGATE X4 Study Participants | 3.14 | NA – 3.2 |
Time frame: Entire follow-up: implant through 5 years post-implant (median participant follow-up = 4.3 years).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | NAVIGATE X4 Study Particip… |
|---|---|---|
| Non-Cardiovascular | General disorders | — |
| Cardiovascular - Non-Heart Failure | Cardiac disorders | — |
| Cardiovascular - Heart Failure | Cardiac disorders | — |
| Procedure-related | Surgical and medical procedures | — |
| Pulse Generator | Product Issues | — |
| RV Lead - Related to RELIANCE 4-FRONT | Product Issues | — |
| RA Lead | Product Issues | — |
| LV Lead - Related to ACUITY X4 | Product Issues | — |
| Lead - Other | Product Issues | — |
| LV Lead - Unrelated to / Not caused by ACUITY X4 | Product Issues | — |
| RV Lead - Unrelated to / Not caused by RELIANCE 4-FRONT | Product Issues | — |
| Unclassified | Investigations | — |
| RV & LV Lead - Related to both RELIANCE 4-FRONT and ACUITY X4 | Product Issues | — |
| Reaction | System | NAVIGATE X4 Study Particip… |
|---|---|---|
| Non-Cardiovascular | General disorders | — |
| Cardiovascular - Non-Heart Failure | Cardiac disorders | — |
| Cardiovascular - Heart Failure | Cardiac disorders | — |
| Procedure-related | Surgical and medical procedures | — |
| LV Lead - Related to ACUITY X4 | Product Issues | — |
| Pulse Generator | Product Issues | — |
| RA Lead | Product Issues | — |
| RV Lead - Related to RELIANCE 4-FRONT | Product Issues | — |
| LV Lead - Unrelated to / Not caused by ACUITY X4 | Product Issues | — |
| RV & LV Lead - Related to both RELIANCE 4-FRONT and ACUITY X4 | Product Issues | — |
| Unclassified | Investigations | — |
| Lead - Other | Product Issues | — |
| RV Lead - Unrelated to / Not caused by RELIANCE 4-FRONT | Product Issues | — |
Most-reported serious reactions: Non-Cardiovascular, Cardiovascular - Non-Heart Failure, Cardiovascular - Heart Failure, Procedure-related, Pulse Generator, RV Lead - Related to RELIANCE 4-FRONT, RA Lead, LV Lead - Related to ACUITY X4.
Data from ClinicalTrials.gov NCT02071173 adverse events section.
The objective of the NAVIGATE X4 Clinical Study is to gather data to establish the safety, performance and effectiveness of the ACUITY™ X4 quadripolar coronary venous leads and the RELIANCE 4-FRONT™ ventricular defibrillation leads to satisfy FDA requirements for pre-market submission. Additionally, data from this study will be used to support post-market approval requirements for the ACUITY X4 and RELIANCE 4-FRONT leads.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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