Clinical trial NCT04645342: Wire Instrumentation Using Radiofrequency Energy to Impact Transseptal Efficiency
Official title: Wire Instrumentation Using Radiofrequency Energy to Impact Transseptal Efficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Atrial Flutter
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Baylis Medical Company
First posted: 2020-11-27
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The transseptal puncture is one of the most commonly performed procedures in the cardiac electrophysiology and interventional cardiology laboratories. Indeed, every atrial fibrillation ablation, now the predominant electrophysiology procedure performed throughout the world, routinely involves two different transseptal puncture procedures. The investigators previously performed a randomized, comparative effectiveness trial demonstrating the superiority (in both efficacy and safety) of a radiofrequency (RF) transseptal needle versus the conventional sharp-tipped mechanical needle. More recently, an alternative approach to transseptal puncture has been FDA approved and is already utilized as part of standard of care in these procedures. With this new approach, a J-shaped wire that can transmit RF energy is advanced inside the transeptal sheath rather than the more stiff RF or conventional needle. As advancing a wire is usually a step employed in any transseptal procedure (then usually requiring removal of that wire and then placement of the needle), this new approach saves a step. In addition once the wire has been advanced across the intra-atrial septum into the left atrium, the wire can be used to avoid potentially severe complications; specifically, after a transseptal needle is advanced across the left atrium, advancing the sheath over the needle can result in a sudden jump of all the equipment, risking perforation of the far left atrial wall. With the wire approach, the wire can be safely advanced into a pulmonary vein so that even if the sheath and dilator jump suddenly across the septum, they will be guided along the wire and thereby avoid perforation. The investigators will be studying patients undergoing a catheter ablation procedure at University of California, San Francisco.

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

Primary outcomes:
measure: Time to Achieve First Transseptal Puncture
timeFrame: 0-30 minutes (from insertion of guidewire to removal of guidewire of first transseptal)
Secondary outcomes:
measure: Time to Achieve Second Transseptal Puncture
timeFrame: 0-30 minutes (from insertion of guidewire to removal of guidewire of second transseptal)
measure: Combined Transseptal Time
timeFrame: 0-60 minutes (summation of first transseptal and second transseptal times)
measure: Fluoroscopy Time
timeFrame: 0-60 minutes (from insertion of guidewire to removal of guidewire of first transseptal and second transseptal)
measure: Number of Participants With Equipment Exchanges
timeFrame: (0-8 hours) duration of cardiac ablation procedure
measure: Complication Rates
timeFrame: complications were assessed during the duration of cardiac ablation procedure (up to 8 hours)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Greg Marcus, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References: