Leadless Ultrasound-Based Cardiac Resynchronization System in Heart Failure Results from the SOLVE-CRT Randomised Sub-study
Bibliographic record
Abstract
Abstract Background Despite the well-established role of CRT in heart failure, major limitations of CRT are an occasional incidence of unsuccessful coronary sinus (CS) lead placement, one third non-responders in conventional CRT patients and higher complications risk in CRT upgrade procedures. The WiSE® Wireless Stimulation Endocardial) CRT System is designed to overcome these limitations. Prior non-randomised studies with the WiSE® CRT System have shown high implant success rates and improvement in LV remodeling and heart failure symptoms. Objectives Pivotal study to assess the safety and effectiveness of the WiSE® CRT System in an international, randomized, two-arm, double blinded, prospective study (randomized part only). Method 99 Patients with indication for CRT and previously failed CRT implant, considered as high-risk upgrade to conventional CRT, or non-responders to conventional CRT underwent device implantation and were then randomised into treatment (47 pts, System ON) and control (52 pts System OFF) groups for 6 months. Primary efficacy endpoints were change in LVESV, LVEDV, LVEF and QRS over 6 months in blinded Echo and ECG core lab analysis. Results Mean ΔLVESV (%) -14.6 (-19.6, -9.6); mean ΔLVEDV (%) -8.1 (-11.9, -4.3) and mean ΔQRS (ms) -41.9 (-50.1, -33.7) in the treatment group were significantly lower/shorter than mean ΔLVESV (%) -5.2 (-10.7, 0.2); mean ΔLVEDV (%) -3.0 (-7.0, 1.0) and mean ΔQRS (ms) -1.7 (-7.1,3.8) in the control group, p=0.005; p=0.027 and p=0.001, 95% CI. Mean ΔLVEF (%) 5.4 (3.2, 7.7) in the treatment group increased significantly compared to control group ΔLVEF (%) 2.4 (0.2, 4.5), p=0.048. 8 of 99 pts were attempted from WiSE CRT implant. Conclusion This randomized sub-study of the pivotal SOLVE-CRT trial demonstrates that leadless, ultrasound-based endocardial pacing for heart failure is feasible and efficacious showing evidence of left ventricular remodelling and electrical response after 6 months.Figure 1WISE® CRT System Figure 2Efficacy entire randomised population
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".