Wire Instrumentation Using Radiofrequency Energy to Impact Transseptal Efficiency

NCT ID: NCT04645342

Last Updated: 2023-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-30
• Study Completion Date: 2022-02-02

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.

Conditions

Atrial Fibrillation; Atrial Flutter

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Baylis Versacross RF wire

Device: Baylis Versacross radiofrequency wire

Group Type: EXPERIMENTAL

Baylis Versacross RF wire

Intervention Type: DEVICE

Baylis Versacross radiofrequency wire is used for transseptal puncture during cardiac ablation procedure.

Baylis RF Needle

Device: conventional Baylis radiofrequency needle

Group Type: ACTIVE_COMPARATOR

Baylis RF needle

Intervention Type: DEVICE

Baylis radiofrequency needle is used for transseptal puncture during cardiac ablation procedure.

Interventions

Baylis Versacross RF wire

Baylis Versacross radiofrequency wire is used for transseptal puncture during cardiac ablation procedure.

Intervention Type: DEVICE

Baylis RF needle

Baylis radiofrequency needle is used for transseptal puncture during cardiac ablation procedure.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylis Medical Company

INDUSTRY

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Greg Marcus, MD, MAS

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

20-30738

Identifier Type: -

Identifier Source: org_study_id