N/A
Completed N=75
Wire Instrumentation Using Radiofrequency Energy to Impact Transseptal Efficiency
Source: ClinicalTrials.gov NCT04645342 ↗Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcomePrimary: Time to Achieve First Transseptal Puncture — 9.2; 6.9 minutes
Summary
This is a randomized controlled trial examining whether Baylis's Versacross RF wire versus the conventional Baylis RF needle is better at puncturing through a thin wall in the heart (called "transseptal puncture") as measured by time to successful transseptal puncture, during cardiac ablation procedures.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Achieve First Transseptal Puncture |
9.2; 6.9 | — |
| SECONDARY Time to Achieve Second Transseptal Puncture |
8.4; 6.0 | — |
| SECONDARY Combined Transseptal Time |
20.5; 14.0 | — |
| SECONDARY Fluoroscopy Time |
2.0; 1.8; 2.4; 1.8 | — |
| SECONDARY Number of Participants With Equipment Exchanges |
0; 37; 26; 0; 5; 2 | — |
| SECONDARY Complication Rates |
1; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 years old
- Patients undergoing endocardial left atrial catheter ablation procedures using radiofrequency ablation catheters for atrial fibrillation or atrial flutter ablation procedures at UCSF
- Willing and able to provide written informed consent in English
- Willing and able to comply with scheduled remote follow-up visits through 1 Year post-operative
Exclusion Criteria
- Presence of a patent foramen ovale closure device or atrial septal defect closure device
- Cryoballoon ablation
- IVC filter
- Deemed not suitable by study personnel
Data sourced from ClinicalTrials.gov (NCT04645342). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.