相关临床试验
15
0 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
N/A
已完成
12
80.0%
招募中
2
13.3%
撤回
1
6.7%
暂无批准数据
- The BIO-LIBRA study achieved unprecedented female representation at 48% in cardiac device trials, revealing that males with non-ischemic cardiomyopathy face twice the risk of death or life-threatening arrhythmias compared to females. - One-year results showed 13% of males experienced adverse outcomes versus 6% of females, representing a 52% lower risk for female patients with implantable cardiac defibrillators. - Researchers overcame traditional enrollment barriers by scheduling visits with routine care, using remote monitoring, and removing age or comorbidity exclusions that disproportionately affected female participation. - The study demonstrates that better demographic representation in clinical trials benefits all patients by providing more accurate risk stratification and treatment guidance.
- Biotronik has enrolled the first patient in the second arm of the BIO-CONDUCT study to evaluate the Solia CSP S pacing lead for left bundle branch area pacing (LBBAP). - The Solia CSP S lead features design enhancements like a fixed helix and optimized distal end, aiming to simplify LBBAP procedures and improve patient outcomes. - LBBAP is gaining traction as a more physiological pacing method compared to conventional techniques, potentially offering better outcomes for heart failure patients. - Several vendors, including Medtronic, Boston Scientific, and Abbott, are developing and receiving FDA clearances for LBBAP-related devices and systems.
- The EP PASSION project successfully transitioned the Solia S cardiac lead post-approval study to real-world data (RWD), demonstrating the feasibility of using claims data for device surveillance. - A proof-of-concept analysis showed no statistically significant difference in identifying lead complications between traditional methods and RWD, with a high overall agreement of 99.7%. - Final results of the Solia S EP PASSION PAS indicated a 97.19% complication-free rate at 5 years post-implant, affirming the long-term safety and reliability of the lead. - The transition to RWD methodologies offers significant resource savings and improved follow-up compared to traditional post-market studies, paving the way for broader applications in device evaluation.
- The FDA has granted approval for Biotronik's Selectra 3D catheter, used with the Solia S lead, for left bundle branch area pacing (LBBAP). - This marks the first FDA-approved stylet-driven lead and dedicated delivery catheter system for LBBAP, offering a new option for cardiac pacing. - The BIO-CONDUCT trial demonstrated a 95.7% implant success rate and a low 1.7% lead-related complication rate at 3 months with the Solia S lead in LBBAP. - The Solia S lead offers advantages over previous LBBAP leads, including continuous pacing off the stylet during implantation.
- The FDA has approved Biotronik's lead and catheter system for left bundle branch area pacing (LBBAP), offering a new option for physiological pacing. - LBBAP aims to improve heart failure outcomes by pacing the heart in a more natural way compared to traditional right ventricular pacing. - The new system provides physicians with specialized tools designed to facilitate accurate and stable lead placement in the left bundle branch area. - This approval expands the options available for patients needing pacing therapy, potentially reducing the risk of heart failure progression.
- The FDA has granted approval for Biotronik's Selectra 3D catheter and Solia S lead system for left bundle branch area pacing (LBBAP). - The approval was based on the BIO-CONDUCT trial, which demonstrated a 95.7% implant success rate and a low 1.7% lead-related complication rate. - The Solia S lead offers advantages over previous LBBAP leads, including continuous pacing off the stylet during implantation, according to Larry Chinitz, MD.
- Biotronik received FDA approval for its Selectra 3D catheter and Solia S lead, making them the first stylet-driven system approved for Left Bundle Branch Area Pacing (LBBAP). - The approval is based on data from the BIO-CONDUCT trial, which demonstrated a 95.7% implant success rate and a 1.7% lead-related complication rate at three months. - The Solia S lead offers advantages over legacy leads, including the ability to continuously pace off the stylet during implantation, according to Dr. Larry Chinitz. - The system has been used in over 80,000 patients worldwide and supports the evolving technique of pacing the heart’s natural conduction system.
