Trial Outcomes & Findings for Transseptal Needle Versus Radiofrequency Energy for Left Atrial Access (NCT NCT01209260)

NCT ID: NCT01209260

Last Updated: 2014-02-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

72 participants

Primary outcome timeframe

Day of procedure

Results posted on

2014-02-28

Participant Flow

Between January 2011 and November 2012, 72 patients were randomized to 1 of 2 transseptal needle groups.

139 patients were assessed for eligibility; 61 declined to participate, 3 met exclusion criteria, 3 did not enroll for other reasons.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	36	36
Overall Study COMPLETED	36	36
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Transseptal Needle Versus Radiofrequency Energy for Left Atrial Access

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Radiofrequency Energy Needle n=36 Participants 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.	Mechanical Needle n=36 Participants 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.	Total n=72 Participants Total of all reporting groups
Age, Continuous	59.9 years STANDARD_DEVIATION 11.3 • n=5 Participants	61.1 years STANDARD_DEVIATION 11.7 • n=7 Participants	60.5 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	23 Participants n=7 Participants	48 Participants n=5 Participants
Region of Enrollment United States	36 participants n=5 Participants	36 participants n=7 Participants	72 participants n=5 Participants
Previous stroke or transient ischemic attack (TIA) Previous stroke or TIA	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Previous stroke or transient ischemic attack (TIA) No previous stroke or TIA	34 participants n=5 Participants	33 participants n=7 Participants	67 participants n=5 Participants
Indication for transseptal puncture Atrial fibrillation	35 participants n=5 Participants	35 participants n=7 Participants	70 participants n=5 Participants
Indication for transseptal puncture Accessory pathway	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
History of transseptal puncture Previous transseptal puncture	12 participants n=5 Participants	10 participants n=7 Participants	22 participants n=5 Participants
History of transseptal puncture No previous transseptal puncture	24 participants n=5 Participants	26 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: Day of procedure

Outcome measures

Outcome measures
Measure	Radiofrequency Energy Needle n=36 Participants 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.	Mechanical Needle n=36 Participants 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.
Transseptal Access Procedure Time	2.3 minutes Interval 1.7 to 3.8	7.3 minutes Interval 2.7 to 14.1

SECONDARY outcome

Timeframe: During or immediately after procedure, up to 1 day after procedure. On average, up to 1 day after the procedure.

Outcome measures

Outcome measures
Measure	Radiofrequency Energy Needle n=36 Participants 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.	Mechanical Needle n=36 Participants 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.
Number of Participants With Adverse Events as a Measure of Safety	1 participants	1 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Radiofrequency Energy Needle n=36 Participants 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.	Mechanical Needle n=36 Participants 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.
Performance of the Assigned Needle Type Success of assigned needle type	36 participants	26 participants
Performance of the Assigned Needle Type Failure of assigned needle type	0 participants	10 participants

SECONDARY outcome

Timeframe: immediately prior to procedure

Population: The assigned needle for each participant was analyzed prior to the 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.

Outcome measures

Outcome measures
Measure	Radiofrequency Energy Needle n=36 Assigned needles 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.	Mechanical Needle n=36 Assigned needles 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.
Plastic Dilator Shavings	0 Needles	12 Needles

Adverse Events

Radiofrequency Energy Needle (RF)

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Mechanical Needle

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Radiofrequency Energy Needle (RF) n=36 participants at risk 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.	Mechanical Needle n=36 participants at risk 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.
Cardiac disorders Pericardial effusion	2.8% 1/36 • Number of events 1 • During or immediately after procedure, up to 1 day after procedure. On average, up to 1 day after the procedure. All patients were monitored for both intraprocedural complications and postprocedural complications until discharge. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.	0.00% 0/36 • During or immediately after procedure, up to 1 day after procedure. On average, up to 1 day after the procedure. All patients were monitored for both intraprocedural complications and postprocedural complications until discharge. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
Vascular disorders Transient ischemic attack	0.00% 0/36 • During or immediately after procedure, up to 1 day after procedure. On average, up to 1 day after the procedure. All patients were monitored for both intraprocedural complications and postprocedural complications until discharge. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.	2.8% 1/36 • Number of events 1 • During or immediately after procedure, up to 1 day after procedure. On average, up to 1 day after the procedure. All patients were monitored for both intraprocedural complications and postprocedural complications until discharge. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.

Other adverse events

Adverse event data not reported

Additional Information

Jonathan Hsu, MD, MAS

University of California San Diego

Phone: 415-476-5706

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place