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| Name | Class |
|---|---|
| Baylis Medical Company | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baylis Versacross RF wire | Experimental | Device: Baylis Versacross radiofrequency wire |
|
| Baylis RF Needle | Active Comparator | Device: conventional Baylis radiofrequency needle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baylis Versacross RF wire | Device | Baylis Versacross radiofrequency wire is used for transseptal puncture during cardiac ablation procedure. |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to Achieve First Transseptal Puncture | First transseptal time was recorded for each participant, starting with insertion of the long guidewire into the femoral short sheath (J wire for RF needle group, VersaCross wire for RF wire group) and stopping once the transseptal sheath was positioned in the LA and the dilator and guidewire were fully removed from the long sheath. Median time in minutes to completion of the first transseptal puncture during the cardiac ablation procedure between the RF needle and RF Wire group was compared as the outcome. | 0-30 minutes (from insertion of guidewire to removal of guidewire of first transseptal) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Achieve Second Transseptal Puncture | Second transseptal time was recorded for each participant, starting with insertion of the long guidewire into the femoral short sheath (J wire for RF needle group, VersaCross wire for RF wire group) and stopping once the transseptal sheath was positioned in the LA and the dilator and guidewire were fully removed from the long sheath. The median time in minutes to completion of the second transseptal puncture during the cardiac ablation procedure between the RF needle and RF Wire group was compared as a secondary outcome. Participants that did not undergo 2 transseptal punctures were not included in this analysis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Greg Marcus, MD, MAS | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
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261 patients were assessed for eligibility; 61 declined to participate, 118 met exclusion criteria, 7 did not enroll for other reasons.
From 11/30/2020 to 2/2/2022, 75 participants were enrolled and randomized in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Baylis RF Needle | Device: conventional Baylis radiofrequency needle Baylis RF needle: Baylis radiofrequency needle is used for transseptal puncture during cardiac ablation procedure. |
| FG001 | Baylis Versacross RF Wire | Device: Baylis Versacross radiofrequency wire Baylis Versacross RF wire: Baylis Versacross radiofrequency wire is used for transseptal puncture during cardiac ablation procedure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Baylis RF Needle | Device: conventional Baylis radiofrequency needle Baylis RF needle: Baylis radiofrequency (RF) needle is used for transseptal puncture during cardiac ablation procedure. |
| BG001 | Baylis Versacross RF Wire |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Achieve First Transseptal Puncture | First transseptal time was recorded for each participant, starting with insertion of the long guidewire into the femoral short sheath (J wire for RF needle group, VersaCross wire for RF wire group) and stopping once the transseptal sheath was positioned in the LA and the dilator and guidewire were fully removed from the long sheath. Median time in minutes to completion of the first transseptal puncture during the cardiac ablation procedure between the RF needle and RF Wire group was compared as the outcome. | Posted | Median | Inter-Quartile Range | minutes | 0-30 minutes (from insertion of guidewire to removal of guidewire of first transseptal) |
|
Adverse event data was collected over 1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Baylis RF Needle | Device: conventional Baylis radiofrequency needle Baylis RF needle: Baylis radiofrequency needle is used for transseptal puncture during cardiac ablation procedure. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Procedure Complications (temporary AV Block) | Cardiac disorders | Systematic Assessment | 1 participant in the needle group had a mechanical injury to the atrioventricular (AV) node and transient ventricular asystole due to AV block, requiring brief pacing, resolved during procedure. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Thomas Dewland | UCSF | 415-476-5706 | thomas.dewland@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 26, 2020 | Nov 18, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 14, 2021 | Nov 18, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Baylis RF needle | Device | Baylis radiofrequency needle is used for transseptal puncture during cardiac ablation procedure. |
|
| 0-30 minutes (from insertion of guidewire to removal of guidewire of second transseptal) |
| Combined Transseptal Time | Combined transseptal time was calculated for each participant by summing up participants' first and second transseptal times. The median combined transseptal time in minutes between the RF needle and RF Wire group was compared as a secondary outcome. Participants that did not undergo two transseptal punctures were not included in this analysis. | 0-60 minutes (summation of first transseptal and second transseptal times) |
| Fluoroscopy Time | Fluoroscopy time (amount of time operators used fluoroscopy during a transseptal puncture) was recorded for each participant, starting with insertion of the long guidewire into the femoral short sheath (J wire for RF needle group, VersaCross wire for RF wire group) and stopping once the transseptal sheath was positioned in the LA and the dilator and guidewire were fully removed from the long sheath. Median fluoroscopy time during the first and second transseptal punctures between the RF needle and RF Wire group was compared as a secondary outcome. | 0-60 minutes (from insertion of guidewire to removal of guidewire of first transseptal and second transseptal) |
| Number of Participants With Equipment Exchanges | An equipment exchange was defined as the removal of the J or RF wire from the dilator and sheath assembly before transseptal puncture; all RF needle punctures required at least 1 equipment exchange, although further exchanges could be performed as necessary if the initial pull-down resulted in inadequate positioning of the sheath and dilator and readvancement of the transseptal assembly into the SVC was necessary. The number of equipment exchanges during the cardiac ablation procedure between the RF need and RF wire groups were compared. | (0-8 hours) duration of cardiac ablation procedure |
| Complication Rates | The number of participants with complications during the procedure between the RF needle and RF wire groups was compared as a secondary outcome. | complications were assessed during the duration of cardiac ablation procedure (up to 8 hours) |
Device: Baylis Versacross radiofrequency wire
Baylis Versacross RF wire: Baylis Versacross radiofrequency (RF) wire is used for transseptal puncture during cardiac ablation procedure.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Median | Inter-Quartile Range | kg |
|
| Prior transseptal procedure | Count of Participants | Participants |
|
| Paroxysmal atrial fibrillation/flutter | Count of Participants | Participants |
|
| CHA2DS2VASC score | The acronym CHA2DS2-VASc stands for congestive heart failure, hypertension, age ≥75 (doubled), diabetes, stroke (doubled), vascular disease, age 65 to 74 and sex category (female). Two points are awarded for stroke, TIA or thromboembolism in the medical history and for age over 75. One point is assigned for age 65 to 75, Hypertension, diabetes mellitus, heart failure or ejection fraction <40%, vascular disease (prior myocardial infarction, peripheral artery disease, aortic plaque), and female sex. Score 0 - low risk, score 1 - medium risk, score ≥2 - high risk. Scores can range from 0-9. | Median | Inter-Quartile Range | scores on a scale (0-9) |
|
| Transvenous pacemaker or defibrillator | Count of Participants | Participants |
|
| Left atrial size by transthoracic echocardiogram (TTE) | Count of Participants | Participants |
|
| Rhythm at time of transseptal | Count of Participants | Participants |
|
| OG001 | Baylis Versacross RF Wire | Device: Baylis Versacross radiofrequency wire Baylis Versacross RF wire: Baylis Versacross radiofrequency wire is used for transseptal puncture during cardiac ablation procedure. |
|
|
| Secondary | Time to Achieve Second Transseptal Puncture | Second transseptal time was recorded for each participant, starting with insertion of the long guidewire into the femoral short sheath (J wire for RF needle group, VersaCross wire for RF wire group) and stopping once the transseptal sheath was positioned in the LA and the dilator and guidewire were fully removed from the long sheath. The median time in minutes to completion of the second transseptal puncture during the cardiac ablation procedure between the RF needle and RF Wire group was compared as a secondary outcome. Participants that did not undergo 2 transseptal punctures were not included in this analysis. | Posted | Median | Inter-Quartile Range | minutes | 0-30 minutes (from insertion of guidewire to removal of guidewire of second transseptal) |
|
|
|
| Secondary | Combined Transseptal Time | Combined transseptal time was calculated for each participant by summing up participants' first and second transseptal times. The median combined transseptal time in minutes between the RF needle and RF Wire group was compared as a secondary outcome. Participants that did not undergo two transseptal punctures were not included in this analysis. | Posted | Median | Inter-Quartile Range | minutes | 0-60 minutes (summation of first transseptal and second transseptal times) |
|
|
|
| Secondary | Fluoroscopy Time | Fluoroscopy time (amount of time operators used fluoroscopy during a transseptal puncture) was recorded for each participant, starting with insertion of the long guidewire into the femoral short sheath (J wire for RF needle group, VersaCross wire for RF wire group) and stopping once the transseptal sheath was positioned in the LA and the dilator and guidewire were fully removed from the long sheath. Median fluoroscopy time during the first and second transseptal punctures between the RF needle and RF Wire group was compared as a secondary outcome. | All participants randomized underwent a first transseptal puncture. 6 patients from the RF needle group and 4 patients in the RF wire group did not undergo a 2nd transseptal puncture. | Posted | Median | Inter-Quartile Range | minutes | 0-60 minutes (from insertion of guidewire to removal of guidewire of first transseptal and second transseptal) |
|
|
|
| Secondary | Number of Participants With Equipment Exchanges | An equipment exchange was defined as the removal of the J or RF wire from the dilator and sheath assembly before transseptal puncture; all RF needle punctures required at least 1 equipment exchange, although further exchanges could be performed as necessary if the initial pull-down resulted in inadequate positioning of the sheath and dilator and readvancement of the transseptal assembly into the SVC was necessary. The number of equipment exchanges during the cardiac ablation procedure between the RF need and RF wire groups were compared. | Posted | Count of Participants | Participants | (0-8 hours) duration of cardiac ablation procedure |
|
|
|
| Secondary | Complication Rates | The number of participants with complications during the procedure between the RF needle and RF wire groups was compared as a secondary outcome. | Posted | Count of Participants | Participants | complications were assessed during the duration of cardiac ablation procedure (up to 8 hours) |
|
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| 0 |
| 36 |
| 0 |
| 36 |
| 1 |
| 36 |
| EG001 | Baylis Versacross RF Wire | Device: Baylis Versacross radiofrequency wire Baylis Versacross RF wire: Baylis Versacross radiofrequency wire is used for transseptal puncture during cardiac ablation procedure. | 0 | 39 | 0 | 39 | 0 | 39 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| 2nd Transseptal |
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| Number of exchanges = 2 |
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| Number of exchanges >= 3 |
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