Trial Outcomes & Findings for A Randomized Comparison of the Use of JET and Conventional Ventilation in Pulmonary Vein Isolation (NCT NCT02664311)
NCT ID: NCT02664311
Last Updated: 2017-04-10
Results Overview
Comparison of Time (in Minutes) From Obtaining Access to Left Atrium Via Transseptal Catheterization to Demonstrated Isolation of All Pulmonary Veins - hypothesis is that with Jet ventilation there will be a shorter time to pulmonary vein isolation in comparison to conventional ventilation
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
Immediate post procedure
Results posted on
2017-04-10
Participant Flow
September 2013-January 2014 at Beth Israel Deaconess Medical Center
Participant milestones
| Measure |
Conventional Ventilation
Patients receiving conventional ventilation for the duration of this study
Conventional ventilation: Conventional ventilator - control arm
|
Jet Ventilation
Patients receiving Jet ventilation while under general anesthesia and during mapping and ablation in the left atrium
Jet Ventilation: Patients are randomized to receive either jet or conventional ventilation during this study
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
|
Overall Study
COMPLETED
|
6
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Randomized Comparison of the Use of JET and Conventional Ventilation in Pulmonary Vein Isolation
Baseline characteristics by cohort
| Measure |
Conventional Ventilation
n=6 Participants
Patients receiving conventional ventilation for the duration of this study
Conventional ventilation: Conventional ventilator - control arm
|
Jet Ventilation
n=3 Participants
Patients receiving Jet ventilation while under general anesthesia and during mapping and ablation in the left atrium
Jet Ventilation: Patients are randomized to receive either jet or conventional ventilation during this study
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 17 • n=5 Participants
|
60 years
STANDARD_DEVIATION 9 • n=7 Participants
|
59 years
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Atrial fibrillation
Atrial fibrillation - paroxysmal
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Atrial fibrillation
Atrial fibrillation - persistent
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Immediate post procedureComparison of Time (in Minutes) From Obtaining Access to Left Atrium Via Transseptal Catheterization to Demonstrated Isolation of All Pulmonary Veins - hypothesis is that with Jet ventilation there will be a shorter time to pulmonary vein isolation in comparison to conventional ventilation
Outcome measures
| Measure |
Conventional Ventilation
n=6 Participants
Patients receiving conventional ventilation for the duration of this study
Conventional ventilation: Conventional ventilator - control arm
|
Jet Ventilation
n=3 Participants
Patients receiving Jet ventilation while under general anesthesia and during mapping and ablation in the left atrium
Jet Ventilation: Patients are randomized to receive either jet or conventional ventilation during this study
|
|---|---|---|
|
Isolation Time
|
127 minutes
Standard Deviation 45
|
117 minutes
Standard Deviation 55
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
Conventional Ventilation
n=6 Participants
Patients receiving conventional ventilation for the duration of this study
Conventional ventilation: Conventional ventilator - control arm
|
Jet Ventilation
n=3 Participants
Patients receiving Jet ventilation while under general anesthesia and during mapping and ablation in the left atrium
Jet Ventilation: Patients are randomized to receive either jet or conventional ventilation during this study
|
|---|---|---|
|
Freedom From AF
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Immediate post-procedureFluoro time as recorded by RNs from Xray machine
Outcome measures
| Measure |
Conventional Ventilation
n=6 Participants
Patients receiving conventional ventilation for the duration of this study
Conventional ventilation: Conventional ventilator - control arm
|
Jet Ventilation
n=3 Participants
Patients receiving Jet ventilation while under general anesthesia and during mapping and ablation in the left atrium
Jet Ventilation: Patients are randomized to receive either jet or conventional ventilation during this study
|
|---|---|---|
|
Fluoroscopy Time
|
54 minutes
Standard Deviation 11.9
|
48 minutes
Standard Deviation 18.8
|
Adverse Events
Conventional Ventilation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Jet Ventilation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place