Trial Outcomes & Findings for Wire Instrumentation Using Radiofrequency Energy to Impact Transseptal Efficiency (NCT NCT04645342)
NCT ID: NCT04645342
Last Updated: 2023-03-14
Results Overview
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.
COMPLETED
NA
75 participants
0-30 minutes (from insertion of guidewire to removal of guidewire of first transseptal)
2023-03-14
Participant Flow
From 11/30/2020 to 2/2/2022, 75 participants were enrolled and randomized in the study.
261 patients were assessed for eligibility; 61 declined to participate, 118 met exclusion criteria, 7 did not enroll for other reasons.
Participant milestones
| Measure |
Baylis RF Needle
Device: conventional Baylis radiofrequency needle
Baylis RF needle: Baylis radiofrequency needle is used for transseptal puncture during cardiac ablation procedure.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
39
|
|
Overall Study
COMPLETED
|
36
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Wire Instrumentation Using Radiofrequency Energy to Impact Transseptal Efficiency
Baseline characteristics by cohort
| Measure |
Baylis RF Needle
n=36 Participants
Device: conventional Baylis radiofrequency needle
Baylis RF needle: Baylis radiofrequency (RF) needle is used for transseptal puncture during cardiac ablation procedure.
|
Baylis Versacross RF Wire
n=39 Participants
Device: Baylis Versacross radiofrequency wire
Baylis Versacross RF wire: Baylis Versacross radiofrequency (RF) wire is used for transseptal puncture during cardiac ablation procedure.
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
n=5 Participants
|
61 years
n=7 Participants
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
26 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Height
|
177 cm
STANDARD_DEVIATION 8 • n=5 Participants
|
176 cm
STANDARD_DEVIATION 9 • n=7 Participants
|
176 cm
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Weight
|
86 kg
n=5 Participants
|
94 kg
n=7 Participants
|
91 kg
n=5 Participants
|
|
Prior transseptal procedure
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Paroxysmal atrial fibrillation/flutter
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
CHA2DS2VASC score
|
3 scores on a scale (0-9)
n=5 Participants
|
3 scores on a scale (0-9)
n=7 Participants
|
3 scores on a scale (0-9)
n=5 Participants
|
|
Transvenous pacemaker or defibrillator
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Left atrial size by transthoracic echocardiogram (TTE)
Normal
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Left atrial size by transthoracic echocardiogram (TTE)
Mild to moderately enlarged
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Left atrial size by transthoracic echocardiogram (TTE)
Severely enlarged
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Rhythm at time of transseptal
Sinus or atrial paced
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Rhythm at time of transseptal
Atrial fibrillation or atrial flutter
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Baylis RF Needle
n=36 Participants
Device: conventional Baylis radiofrequency needle
Baylis RF needle: Baylis radiofrequency needle is used for transseptal puncture during cardiac ablation procedure.
|
Baylis Versacross RF Wire
n=39 Participants
Device: Baylis Versacross radiofrequency wire
Baylis Versacross RF wire: Baylis Versacross radiofrequency wire is used for transseptal puncture during cardiac ablation procedure.
|
|---|---|---|
|
Time to Achieve First Transseptal Puncture
|
9.2 minutes
Interval 5.7 to 11.2
|
6.9 minutes
Interval 5.2 to 8.4
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Baylis RF Needle
n=30 Participants
Device: conventional Baylis radiofrequency needle
Baylis RF needle: Baylis radiofrequency needle is used for transseptal puncture during cardiac ablation procedure.
|
Baylis Versacross RF Wire
n=35 Participants
Device: Baylis Versacross radiofrequency wire
Baylis Versacross RF wire: Baylis Versacross radiofrequency wire is used for transseptal puncture during cardiac ablation procedure.
|
|---|---|---|
|
Time to Achieve Second Transseptal Puncture
|
8.4 minutes
Interval 5.5 to 13.4
|
6.0 minutes
Interval 4.9 to 7.8
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Baylis RF Needle
n=30 Participants
Device: conventional Baylis radiofrequency needle
Baylis RF needle: Baylis radiofrequency needle is used for transseptal puncture during cardiac ablation procedure.
|
Baylis Versacross RF Wire
n=35 Participants
Device: Baylis Versacross radiofrequency wire
Baylis Versacross RF wire: Baylis Versacross radiofrequency wire is used for transseptal puncture during cardiac ablation procedure.
|
|---|---|---|
|
Combined Transseptal Time
|
20.5 minutes
Interval 14.0 to 27.7
|
14.0 minutes
Interval 10.6 to 15.6
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Baylis RF Needle
n=36 Participants
Device: conventional Baylis radiofrequency needle
Baylis RF needle: Baylis radiofrequency needle is used for transseptal puncture during cardiac ablation procedure.
|
Baylis Versacross RF Wire
n=39 Participants
Device: Baylis Versacross radiofrequency wire
Baylis Versacross RF wire: Baylis Versacross radiofrequency wire is used for transseptal puncture during cardiac ablation procedure.
|
|---|---|---|
|
Fluoroscopy Time
1st Transseptal
|
2.0 minutes
Interval 1.6 to 3.2
|
1.8 minutes
Interval 1.3 to 2.2
|
|
Fluoroscopy Time
2nd Transseptal
|
2.4 minutes
Interval 1.6 to 3.5
|
1.8 minutes
Interval 1.5 to 2.7
|
SECONDARY outcome
Timeframe: (0-8 hours) duration of cardiac ablation procedureAn 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.
Outcome measures
| Measure |
Baylis RF Needle
n=36 Participants
Device: conventional Baylis radiofrequency needle
Baylis RF needle: Baylis radiofrequency needle is used for transseptal puncture during cardiac ablation procedure.
|
Baylis Versacross RF Wire
n=39 Participants
Device: Baylis Versacross radiofrequency wire
Baylis Versacross RF wire: Baylis Versacross radiofrequency wire is used for transseptal puncture during cardiac ablation procedure.
|
|---|---|---|
|
Number of Participants With Equipment Exchanges
Number of exchanges = 0
|
0 Participants
|
37 Participants
|
|
Number of Participants With Equipment Exchanges
Number of exchanges = 1
|
26 Participants
|
0 Participants
|
|
Number of Participants With Equipment Exchanges
Number of exchanges = 2
|
5 Participants
|
2 Participants
|
|
Number of Participants With Equipment Exchanges
Number of exchanges >= 3
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Baylis RF Needle
n=36 Participants
Device: conventional Baylis radiofrequency needle
Baylis RF needle: Baylis radiofrequency needle is used for transseptal puncture during cardiac ablation procedure.
|
Baylis Versacross RF Wire
n=39 Participants
Device: Baylis Versacross radiofrequency wire
Baylis Versacross RF wire: Baylis Versacross radiofrequency wire is used for transseptal puncture during cardiac ablation procedure.
|
|---|---|---|
|
Complication Rates
|
1 Participants
|
0 Participants
|
Adverse Events
Baylis RF Needle
Baylis Versacross RF Wire
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Baylis RF Needle
n=36 participants at risk
Device: conventional Baylis radiofrequency needle
Baylis RF needle: Baylis radiofrequency needle is used for transseptal puncture during cardiac ablation procedure.
|
Baylis Versacross RF Wire
n=39 participants at risk
Device: Baylis Versacross radiofrequency wire
Baylis Versacross RF wire: Baylis Versacross radiofrequency wire is used for transseptal puncture during cardiac ablation procedure.
|
|---|---|---|
|
Cardiac disorders
Procedure Complications (temporary AV Block)
|
2.8%
1/36 • Number of events 1 • Adverse event data was collected over 1 year
|
0.00%
0/39 • Adverse event data was collected over 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place