Clinical Trial of Transthoracic Echocardiography Guided Leadless Pacemaker Implantation

10 patients underwent completely fluoroscopy-free leadless pacemaker implantation guided by transthoracic echocardiography and the Panna guidewire. The study compares this cohort to 44 historical fluoroscopy-guided controls, with data on procedural success, safety, and skin-to-skin duration collected over a median 4.7-month follow-up.

Use Cases

• Analyze procedural duration and success rates between the 10-patient TTE-guided cohort and 44 fluoroscopy-guided controls.
• Evaluate the relationship between preoperative TTE acoustic window grading and procedural outcomes like the 'gooseneck' sign assessment.
• Assess pacing parameters and adverse event rates during the short-term follow-up period for safety validation.

Strengths

• Formally predefined safety and efficacy endpoints prior to patient enrollment.
• Comparative analysis uses propensity score overlap weighting on 44 control patients to balance baseline covariates.
• 100% procedural success rate reported for the 10-patient TTE-guided cohort with no adverse events.

Limitations

• Small sample size of 10 patients in the primary intervention group limits statistical power.
• Long-term follow-up data (12/24 months) is incomplete as the study is ongoing.
• Single-arm design for the intervention cohort with retrospective historical controls may introduce bias.

Provenance

Source

Qiuzhe Guo via figshare.

Collection Method

Prospectively protocolized, single-arm clinical study with retrospective comparative analysis of a historical control group.

Time Range

Intervention cohort: July 2024–July 2025. Control group: January 2020–December 2023.

Freshness

Data collection period from July 2024 to July 2025, with last update in March 2026.

Geography

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