An interventional study of Radiofrequency energy needle and Mechanical Needle in Heart Diseases, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-02-28.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment
This is a randomized controlled trial examining whether a mechanical needle versus a needle that uses radiofrequency energy is better at puncturing through a thin wall in the heart (called "transseptal puncture") as measured by procedure time, during an electrical procedure/study of the heart .
Transseptal puncture is a commonly performed procedure allowing access to the left atrium for catheter ablation. Historically, a conventional Brockenbrough needle has been used for this procedure to mechanically puncture the fossa ovalis, which has been well described in the literature.1, 2 Although generally safe, serious complications such as perforation of the atrial wall or aorta can occur.3, 4
Previous studies have evaluated the feasibility and safety of radiofrequency (RF) energy applied to a conventional needle as a technique to access the left atrium, particularly in patients with a repeat procedure, fibrotic septum or aneurysmal septum.5, 6 As a result of this earlier work, a special proprietary device has been designed. The NRG RF needle (Baylis Medical Inc., Montreal, Canada), uses radiofrequency energy emitted from the needle tip to aid in transseptal access. Despite limited literature to support its superiority and safety7-9compared to the conventional approach, the new device has become adopted in some electrophysiology procedures involving a transseptal puncture.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's enrollment of 72 is below the median of 100 across 1,778 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
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Exclusion Criteria:
Radiofrequency energy needle for transseptal access
Device: Radiofrequency energy needle
Mechanical (Brockenbrough) needle for transseptal access
Device: Mechanical Needle
Radiofrequency energy needle for transseptal access
Also known as: Baylis Medical Inc. transseptal needle, NRG RF transseptal needle
Mechanical needle for transseptal access
Also known as: Brockenbrough Needle
Transseptal Access Procedure Time
Total amount of procedure time, from the beginning of the transseptal procedure until left atrium (LA) access is obtained in each patient. Participants for whom puncture failed crossed over to the other Intervention. Analysis performed on an intention-to-treat basis.
Time frame: Day of procedure
Number of Participants With Adverse Events as a Measure of Safety
Time frame: During or immediately after procedure, up to 1 day after procedure. On average, up to 1 day after the procedure.
Performance of the Assigned Needle Type
Failure to achieve transseptal access with the assigned needle type resulted in crossover because of an inability to puncture the interatrial septem despite forward pressure and tenting, leading to concern that further effort might lead to perforation of the free (lateral) LA wall.
Time frame: at time of procedure
Plastic Dilator Shavings
In ex vivo pre-procedural testing, the assigned transseptal needle was advanced through the plastic dilator and sheath, and the presence of grossly visible plastic shavings after introduction of the needle through the dilator and long sheath was recorded.
Time frame: immediately prior to procedure
Between January 2011 and November 2012, 72 patients were randomized to 1 of 2 transseptal needle groups.
| Milestone | Radiofrequency Energy Needle | Mechanical Needle |
|---|---|---|
| Started | 36 | 36 |
| Completed | 36 | 36 |
| Not completed | 0 | 0 |
Total amount of procedure time, from the beginning of the transseptal procedure until left atrium (LA) access is obtained in each patient. Participants for whom puncture failed crossed over to the other Intervention. Analysis performed on an intention-to-treat basis.
| minutes | Radiofrequency Energy Needle | Mechanical Needle |
|---|---|---|
| Transseptal Access Procedure Time | 2.3 (1.7 to 3.8) | 7.3 (2.7 to 14.1) |
| participants | Radiofrequency Energy Needle | Mechanical Needle |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety | 1 | 1 |
Failure to achieve transseptal access with the assigned needle type resulted in crossover because of an inability to puncture the interatrial septem despite forward pressure and tenting, leading to concern that further effort might lead to perforation of the free (lateral) LA wall.
| participants | Radiofrequency Energy Needle | Mechanical Needle |
|---|---|---|
| Success of assigned needle type | 36 | 26 |
| Failure of assigned needle type | 0 | 10 |
In ex vivo pre-procedural testing, the assigned transseptal needle was advanced through the plastic dilator and sheath, and the presence of grossly visible plastic shavings after introduction of the needle through the dilator and long sheath was recorded.
| Needles | Radiofrequency Energy Needle | Mechanical Needle |
|---|---|---|
| Plastic Dilator Shavings | 0 | 12 |
Collected over During or immediately after procedure, up to 1 day after procedure. On average, up to 1 day after the procedure.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Radiofrequency Energy Needle (RF) | — | 1/36 (2.8%) | 0/36 (0%) |
| Mechanical Needle | — | 1/36 (2.8%) | 0/36 (0%) |
| Event | Radiofrequency Energy Needle (RF) | Mechanical Needle |
|---|---|---|
| Pericardial effusionCardiac disorders | 1/36 | 0/36 |
| Transient ischemic attackVascular disorders | 0/36 | 1/36 |
per protocol
| Age, Continuous(years) | Radiofrequency Energy Needle | Mechanical Needle | Total |
|---|---|---|---|
| Mean | 59.9 ± 11.3 | 61.1 ± 11.7 | 60.5 ± 11.4 |
| Sex: Female, Male(Participants) | Radiofrequency Energy Needle | Mechanical Needle | Total |
|---|---|---|---|
| Female | 11 | 13 | 24 |
| Male | 25 | 23 | 48 |
| Region of Enrollment(participants) | Radiofrequency Energy Needle | Mechanical Needle | Total |
|---|---|---|---|
| United States | 36 | 36 | 72 |
| Previous stroke or transient ischemic attack (TIA)(participants) | Radiofrequency Energy Needle | Mechanical Needle | Total |
|---|---|---|---|
| Previous stroke or TIA | 2 | 3 | 5 |
| No previous stroke or TIA | 34 | 33 | 67 |
| Indication for transseptal puncture(participants) | Radiofrequency Energy Needle | Mechanical Needle | Total |
|---|---|---|---|
| Atrial fibrillation | 35 | 35 | 70 |
| Accessory pathway | 1 | 1 | 2 |
| History of transseptal puncture(participants) | Radiofrequency Energy Needle | Mechanical Needle | Total |
|---|---|---|---|
| Previous transseptal puncture | 12 | 10 | 22 |
| No previous transseptal puncture | 24 | 26 | 50 |
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco