Atrial Fibrillation, Atrial Flutter
Conditions
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.
Interventions
DEVICEBaylis Versacross RF wire
Baylis Versacross radiofrequency wire is used for transseptal puncture during cardiac ablation procedure.
DEVICEBaylis RF needle
Baylis radiofrequency needle is used for transseptal puncture during cardiac ablation procedure.
Sponsors
Baylis Medical Company
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Achieve First Transseptal Puncture | 0-30 minutes (from insertion of guidewire to removal of guidewire of first transseptal) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Achieve Second Transseptal Puncture | 0-30 minutes (from insertion of guidewire to removal of guidewire of second transseptal) | 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. |
| Combined Transseptal Time | 0-60 minutes (summation of first transseptal and second transseptal times) | 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. |
| Fluoroscopy Time | 0-60 minutes (from insertion of guidewire to removal of guidewire of first transseptal and second transseptal) | 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. |
| Number of Participants With Equipment Exchanges | (0-8 hours) duration of cardiac ablation procedure | 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. |
| Complication Rates | complications were assessed during the duration of cardiac ablation procedure (up to 8 hours) | The number of participants with complications during the procedure between the RF needle and RF wire groups was compared as a secondary outcome. |
Countries
United States
Participant flow
Recruitment details
From 11/30/2020 to 2/2/2022, 75 participants were enrolled and randomized in the study.
Pre-assignment details
261 patients were assessed for eligibility; 61 declined to participate, 118 met exclusion criteria, 7 did not enroll for other reasons.
Participants by arm
| Arm | Count |
|---|---|
| Baylis RF Needle Device: conventional Baylis radiofrequency needle
Baylis RF needle: Baylis radiofrequency (RF) needle is used for transseptal puncture during cardiac ablation procedure. | 36 |
| Baylis Versacross RF Wire Device: Baylis Versacross radiofrequency wire
Baylis Versacross RF wire: Baylis Versacross radiofrequency (RF) wire is used for transseptal puncture during cardiac ablation procedure. | 39 |
| Total | 75 |
Baseline characteristics
| Characteristic | Baylis Versacross RF Wire | Total | Baylis RF Needle |
|---|---|---|---|
| Age, Continuous | 61 years | 63 years | 64 years |
| CHA2DS2VASC score | 3 scores on a scale (0-9) | 3 scores on a scale (0-9) | 3 scores on a scale (0-9) |
| Height | 176 cm STANDARD_DEVIATION 9 | 176 cm STANDARD_DEVIATION 14 | 177 cm STANDARD_DEVIATION 8 |
| Left atrial size by transthoracic echocardiogram (TTE) Mild to moderately enlarged | 16 Participants | 34 Participants | 18 Participants |
| Left atrial size by transthoracic echocardiogram (TTE) Normal | 16 Participants | 28 Participants | 12 Participants |
| Left atrial size by transthoracic echocardiogram (TTE) Severely enlarged | 7 Participants | 13 Participants | 6 Participants |
| Paroxysmal atrial fibrillation/flutter | 16 Participants | 34 Participants | 18 Participants |
| Prior transseptal procedure | 9 Participants | 16 Participants | 7 Participants |
| Race/Ethnicity, Customized Asian | 5 Participants | 10 Participants | 5 Participants |
| Race/Ethnicity, Customized Black | 2 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 4 Participants | 8 Participants | 4 Participants |
| Race/Ethnicity, Customized White | 28 Participants | 54 Participants | 26 Participants |
| Rhythm at time of transseptal Atrial fibrillation or atrial flutter | 18 Participants | 33 Participants | 15 Participants |
| Rhythm at time of transseptal Sinus or atrial paced | 21 Participants | 42 Participants | 21 Participants |
| Sex: Female, Male Female | 10 Participants | 18 Participants | 8 Participants |
| Sex: Female, Male Male | 29 Participants | 57 Participants | 28 Participants |
| Transvenous pacemaker or defibrillator | 4 Participants | 7 Participants | 3 Participants |
| Weight | 94 kg | 91 kg | 86 kg |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 39 |
| other Total, other adverse events | 1 / 36 | 0 / 39 |
| serious Total, serious adverse events | 0 / 36 | 0 / 39 |
Outcome results
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.
Time frame: 0-30 minutes (from insertion of guidewire to removal of guidewire of first transseptal)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Baylis RF Needle | Time to Achieve First Transseptal Puncture | 9.2 minutes |
| Baylis Versacross RF Wire | Time to Achieve First Transseptal Puncture | 6.9 minutes |
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.
Time frame: 0-60 minutes (summation of first transseptal and second transseptal times)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Baylis RF Needle | Combined Transseptal Time | 20.5 minutes |
| Baylis Versacross RF Wire | Combined Transseptal Time | 14.0 minutes |
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.
Time frame: complications were assessed during the duration of cardiac ablation procedure (up to 8 hours)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Baylis RF Needle | Complication Rates | 1 Participants |
| Baylis Versacross RF Wire | Complication Rates | 0 Participants |
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.
Time frame: 0-60 minutes (from insertion of guidewire to removal of guidewire of first transseptal and second transseptal)
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Baylis RF Needle | Fluoroscopy Time | 1st Transseptal | 2.0 minutes |
| Baylis RF Needle | Fluoroscopy Time | 2nd Transseptal | 2.4 minutes |
| Baylis Versacross RF Wire | Fluoroscopy Time | 1st Transseptal | 1.8 minutes |
| Baylis Versacross RF Wire | Fluoroscopy Time | 2nd Transseptal | 1.8 minutes |
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.
Time frame: (0-8 hours) duration of cardiac ablation procedure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Baylis RF Needle | Number of Participants With Equipment Exchanges | Number of exchanges = 0 | 0 Participants |
| Baylis RF Needle | Number of Participants With Equipment Exchanges | Number of exchanges = 2 | 5 Participants |
| Baylis RF Needle | Number of Participants With Equipment Exchanges | Number of exchanges = 1 | 26 Participants |
| Baylis RF Needle | Number of Participants With Equipment Exchanges | Number of exchanges >= 3 | 5 Participants |
| Baylis Versacross RF Wire | Number of Participants With Equipment Exchanges | Number of exchanges = 1 | 0 Participants |
| Baylis Versacross RF Wire | Number of Participants With Equipment Exchanges | Number of exchanges = 0 | 37 Participants |
| Baylis Versacross RF Wire | Number of Participants With Equipment Exchanges | Number of exchanges >= 3 | 0 Participants |
| Baylis Versacross RF Wire | Number of Participants With Equipment Exchanges | Number of exchanges = 2 | 2 Participants |
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.
Time frame: 0-30 minutes (from insertion of guidewire to removal of guidewire of second transseptal)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Baylis RF Needle | Time to Achieve Second Transseptal Puncture | 8.4 minutes |
| Baylis Versacross RF Wire | Time to Achieve Second Transseptal Puncture | 6.0 minutes |