Heart Diseases
Conditions
Keywords
Transseptal Puncture, Radiofrequency Energy, Left Atrium Access, Left Atrial Catheterization, Ablation, Transseptal Catheterization, Electrocautery, Catheter Ablation, Atrial Fibrillation
Brief summary
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 .
Detailed description
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.
Interventions
DEVICERadiofrequency energy needle
Radiofrequency energy needle for transseptal access
DEVICEMechanical Needle
Mechanical needle for transseptal access
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
* Patients undergoing radiofrequency ablation within the left atrium through a transseptal approach * Patients greater than 18 years of age
Exclusion criteria
* Patients unable to grant informed, written consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transseptal Access Procedure Time | Day of procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety | 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 | at time of procedure | 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. |
| Plastic Dilator Shavings | immediately prior to procedure | 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. |
Countries
United States
Participant flow
Recruitment details
Between January 2011 and November 2012, 72 patients were randomized to 1 of 2 transseptal needle groups.
Pre-assignment details
139 patients were assessed for eligibility; 61 declined to participate, 3 met exclusion criteria, 3 did not enroll for other reasons.
Participants by arm
| Arm | Count |
|---|---|
| Radiofrequency Energy Needle Transseptal access using a radiofrequency energy needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis. | 36 |
| Mechanical Needle Transseptal access using a mechanical (Brockenbrough) needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis. | 36 |
| Total | 72 |
Baseline characteristics
| Characteristic | Radiofrequency Energy Needle | Mechanical Needle | Total |
|---|---|---|---|
| Age, Continuous | 59.9 years STANDARD_DEVIATION 11.3 | 61.1 years STANDARD_DEVIATION 11.7 | 60.5 years STANDARD_DEVIATION 11.4 |
| History of transseptal puncture No previous transseptal puncture | 24 participants | 26 participants | 50 participants |
| History of transseptal puncture Previous transseptal puncture | 12 participants | 10 participants | 22 participants |
| Indication for transseptal puncture Accessory pathway | 1 participants | 1 participants | 2 participants |
| Indication for transseptal puncture Atrial fibrillation | 35 participants | 35 participants | 70 participants |
| Previous stroke or transient ischemic attack (TIA) No previous stroke or TIA | 34 participants | 33 participants | 67 participants |
| Previous stroke or transient ischemic attack (TIA) Previous stroke or TIA | 2 participants | 3 participants | 5 participants |
| Region of Enrollment United States | 36 participants | 36 participants | 72 participants |
| Sex: Female, Male Female | 11 Participants | 13 Participants | 24 Participants |
| Sex: Female, Male Male | 25 Participants | 23 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 36 | 0 / 36 |
| serious Total, serious adverse events | 1 / 36 | 1 / 36 |
Outcome results
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Radiofrequency Energy Needle | Transseptal Access Procedure Time | 2.3 minutes |
| Mechanical Needle | Transseptal Access Procedure Time | 7.3 minutes |
Comparison: Sample size of 72 was targeted to achieve 80% power to detect a 5-minute reduction in transseptal access procedure time (assuming a standard deviation of 7.5 minutes), using a 2-sided alpha of 0.05, with the primary analysis done on an intention-to-treat basis.p-value: 0.005t-test, 2 sided
Secondary
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Radiofrequency Energy Needle | Number of Participants With Adverse Events as a Measure of Safety | 1 participants |
| Mechanical Needle | Number of Participants With Adverse Events as a Measure of Safety | 1 participants |
Secondary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Radiofrequency Energy Needle | Performance of the Assigned Needle Type | Success of assigned needle type | 36 participants |
| Radiofrequency Energy Needle | Performance of the Assigned Needle Type | Failure of assigned needle type | 0 participants |
| Mechanical Needle | Performance of the Assigned Needle Type | Success of assigned needle type | 26 participants |
| Mechanical Needle | Performance of the Assigned Needle Type | Failure of assigned needle type | 10 participants |
p-value: <0.001Chi-squared
Secondary
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
Population: The assigned needle for each participant was analyzed prior to the procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Radiofrequency Energy Needle | Plastic Dilator Shavings | 0 Needles |
| Mechanical Needle | Plastic Dilator Shavings | 12 Needles |
p-value: <0.001Chi-squared