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The purpose of the BIO-CONDUCT study is to demonstrate the safety and effectiveness of the BIOTRONIK Solia CSP S pacing lead when implanted in the left bundle branch area (LBBA). Safety will be assessed by evaluating serious adverse device effects that occur through 3 months post-implant. Efficacy will be assessed by evaluating implant success rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Solia CSP S LBB Lead | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solia CSP S lead | Device | The Solia CSP S pacing lead will be implanted in the LBBA for patients who meet all inclusion/exclusion criteria and give written informed consent. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Device Effect (SADE)-Free Rate at 3 Months | Serious adverse device effect includes both serious lead related and serious implant related device effects. The overall percentage of subjects without serious lead related adverse device effects related to Solia CSP S lead utilized or attempted to be implanted in the LBBA and serious implant procedure events related to the Solia CSP S LBBA lead will be reported. | 3 months post-implant |
| Implant Success Rate | The overall percentage of subjects with successful placement of Solia CSP S lead in LBBA will be reported. | At implant procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (QOL) from Baseline through 12 Months Post-Implant | This secondary outcome will evaluate the improvement in QOL for subjects with the Solia CSP S lead implanted in the LBBA. The parameter of interest is the change in the physical function SF-36 (36-Item Short Form Health Survey) QOL scale from pre-implant baseline to 12 months post-implant, which will be calculated as the mean change from baseline for all subjects that complete both the baseline QOL and 12-month QOL questionnaire. Note that all items are scored so that a high score defines a more favorable health state. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner - University Medical Center Phoenix | Phoenix | Arizona | 85006 | United States | ||
| Cardiology Associates Medical Group |
De-identified participant level data collected within the study will be shared for approved requests.
The data will be available beginning no later than 12 months and ending 3 years after study completion.
Proposals should be directed to BIOTRONIK Clinical Studies (BIOTRONIK Inc., Attn: Clinical Studies, 6024 Jean Road, Lake Oswego, OR; 1-800-547-0394). BIOTRONIK, in consultation with the National Principal Investigator, will review and critique requests for scientific merit, fiscal feasibility, and logistical feasibility. If approved, the data requestors will need to sign a data use/access agreement prior to obtaining the data. BIOTRONIK reserves the right to delete any confidential information or other proprietary information (including trade secrets and patent protected materials) from the shared information.
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| 12 months post-implant |
| Serious Adverse Device Effect (SADE)-Free Rate at 6 Months | Serious adverse device effect includes both serious lead related and serious implant related device effects. The overall percentage of subjects without serious lead related adverse device effects related to Solia CSP S lead utilized or attempted to be implanted in the LBBA and serious implant procedure events related to the Solia CSP S LBBA lead will be reported. | 6 months post-implant |
| Serious Adverse Device Effect (SADE)-Free Rate at 12 Months | Serious adverse device effect includes both serious lead related and serious implant related device effects. The overall percentage of subjects without serious lead related adverse device effects related to Solia CSP S lead utilized or attempted to be implanted in the LBBA and serious implant procedure events related to the Solia CSP S LBBA lead will be reported. | 12 months post-implant |
| Pacing Threshold Measurements at 3 Months | Pacing threshold measurements for Solia CSP S leads implanted in the LBBA at the 3 month follow-up visit. | 3 months post-implant |
| Sensing Measurements at 3 Months | R-wave sensing amplitude measurements for Solia CSP S leads implanted in the LBBA at the 3 month follow-up visit. | 3 months post-implant |
| Pacing Impedance at 3 Months | Pacing impedance measurements for Solia CSP S leads implanted in the LBBA at the 3 month follow-up visit. | 3 months post-implant |
| Pacing Threshold Measurements at 6 Months | Pacing threshold measurements for Solia CSP S leads implanted in the LBBA at the 6 month follow-up visit. | 6 months post-implant |
| Sensing Measurements at 6 Months | R-wave sensing amplitude measurements for Solia CSP S leads implanted in the LBBA at the 6 month follow-up visit. | 6 months post-implant |
| Pacing Impedance at 6 Months | Pacing impedance measurements for Solia CSP S leads implanted in the LBBA at the 6 month follow-up visit. | 6 months post-implant |
| Pacing Threshold Measurements at 12 Months | Pacing threshold measurements for Solia CSP S leads implanted in the LBBA at the 12 month follow-up visit. | 12 months post-implant |
| Sensing Measurements at 12 Months | R-wave sensing amplitude measurements for Solia CSP S leads implanted in the LBBA at the 12 month follow-up visit. | 12 months post-implant |
| Pacing Impedance at 12 Months | Pacing impedance measurements for Solia CSP S leads implanted in the LBBA at the 12 month follow-up visit. | 12 months post-implant |
| Ventura |
| California |
| 93003 |
| United States |
| Sarasota Memorial Hospital | Sarasota | Florida | 34239 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Cardiology Associates Research, LLC | Tupelo | Mississippi | 38801 | United States |
| NYU Heart Rhythm Center | New York | New York | 10016 | United States |
| Weill Cornell Medicine | New York | New York | 10021 | United States |
| Atrium Health Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| Cardiology Consultants of Philadelphia | Paoli | Pennsylvania | 19301 | United States |
| Geisinger Wyoming Valley Medical Center | Wilkes-Barre | Pennsylvania | 18711 | United States |
| ID | Term |
|---|---|
| D012804 | Sick Sinus Syndrome |
| D001919 | Bradycardia |
| D054537 | Atrioventricular Block |
| ID | Term |
|---|---|
| D001146 | Arrhythmia, Sinus |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006327 | Heart Block |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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