Trial Outcomes & Findings for Atrial Pressure Electrophysiology Pilot Study (NCT NCT01845974)
NCT ID: NCT01845974
Last Updated: 2024-10-03
Results Overview
The objective of this pilot study is to investigate the use of a lower flow catheter (ThermoCool® SF NAV Catheter, Biosense Webster, Inc. Diamond Bar, CA, eluting 8-15ml/minute during RF lesion delivery) vs. a higher flow catheter (ThermoCool® catheter, same manufacturer, eluting 17-30 ml/minute), Outcomes are measured by number of Participants with Hemodynamic, Electrolyte, and Electrophysiologic Derangements, is reported. This was measured as participants requiring electrolyte replacement, if the BP dropped below 100 mm in CICU or if participants sustained atrial tachyarrhythmias
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
Observation period is up to the 24 hours post procedure
Results posted on
2024-10-03
Participant Flow
all patients scheduled for atrial fibrillation ablation referred to study coordinator. Non qualifying reasons include: Clot on TEE;Persistant AFib despite previous treatments;Combo treatment needed for both atrial fibrillation and flutter; Declined participation:Afib the morning of procedure;ICD;Rhythm other than Sinus Rhythm
Participant milestones
| Measure |
Low Flow Catheter
The experimental group will receive the low flow catheter (ThermoCool® SF NAV Catheter) All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.
ThermoCool® SF NAV Catheter: The experimental group will receive the low flow catheter (ThermoCool® SF NAV Catheter) All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.
|
High Flow Catheter
The control group will receive the higher flow catheter (ThermoCool® catheter). All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.
ThermoCool® catheter: The control group will receive the higher flow catheter (ThermoCool® catheter). All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
9
|
|
Overall Study
COMPLETED
|
3
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Low Flow Catheter
The experimental group will receive the low flow catheter (ThermoCool® SF NAV Catheter) All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.
ThermoCool® SF NAV Catheter: The experimental group will receive the low flow catheter (ThermoCool® SF NAV Catheter) All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.
|
High Flow Catheter
The control group will receive the higher flow catheter (ThermoCool® catheter). All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.
ThermoCool® catheter: The control group will receive the higher flow catheter (ThermoCool® catheter). All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.
|
|---|---|---|
|
Overall Study
screen failure
|
1
|
0
|
Baseline Characteristics
Atrial Pressure Electrophysiology Pilot Study
Baseline characteristics by cohort
| Measure |
Low Flow Catheter
n=4 Participants
The experimental group will receive the low flow catheter (ThermoCool® SF NAV Catheter) All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.
ThermoCool® SF NAV Catheter: The experimental group will receive the low flow catheter (ThermoCool® SF NAV Catheter) All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.
|
High Flow Catheter
n=9 Participants
The control group will receive the higher flow catheter (ThermoCool® catheter). All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.
ThermoCool® catheter: The control group will receive the higher flow catheter (ThermoCool® catheter). All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 16.5 • n=99 Participants
|
61.3 years
STANDARD_DEVIATION 9 • n=107 Participants
|
61.23 years
STANDARD_DEVIATION 11.08 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Comorbidities
Hypertension
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Comorbidities
Heart Failure
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Comorbidities
Diabetes
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Comorbidities
Obstructive sleep apnea
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Comorbidities
Coronary artery disease
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Tobacco history
|
0 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Previous therapies
statin
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Previous therapies
angiotensin 2 receptor blockers
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Previous therapies
angiotensin converting enzymes
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Previous therapies
beta blockers
|
2 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Previous therapies
digoxin
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Previous therapies
spiranolactone
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Previous therapies
diuretic
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
CHADsVasc 2 score= 2+
|
3 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
prior cardiac surgery
pacemaker
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
prior cardiac surgery
coronary artery bypass grafting
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
prior cardiac surgery
surgical maze
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
prior cardiac surgery
right atrial flutter ablation
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
prior cardiac surgery
prior catheter Radiofrequency ablation for Afib
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Prior Antiarrhythmia drug failure
none
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Prior Antiarrhythmia drug failure
sotolol
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Prior Antiarrhythmia drug failure
dofetilide
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Prior Antiarrhythmia drug failure
fleccainide
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Prior Antiarrhythmia drug failure
dronedarone
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Prior Antiarrhythmia drug failure
ammiodarone and fleccainide
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Prior Antiarrhythmia drug failure
ammiodarone and dronedarone
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Observation period is up to the 24 hours post procedureThe objective of this pilot study is to investigate the use of a lower flow catheter (ThermoCool® SF NAV Catheter, Biosense Webster, Inc. Diamond Bar, CA, eluting 8-15ml/minute during RF lesion delivery) vs. a higher flow catheter (ThermoCool® catheter, same manufacturer, eluting 17-30 ml/minute), Outcomes are measured by number of Participants with Hemodynamic, Electrolyte, and Electrophysiologic Derangements, is reported. This was measured as participants requiring electrolyte replacement, if the BP dropped below 100 mm in CICU or if participants sustained atrial tachyarrhythmias
Outcome measures
| Measure |
Low Flow Catheter
n=3 Participants
The experimental group will receive the low flow catheter (ThermoCool® SF NAV Catheter) All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.
ThermoCool® SF NAV Catheter: The experimental group will receive the low flow catheter (ThermoCool® SF NAV Catheter) All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.
|
High Flow Catheter
n=9 Participants
The control group will receive the higher flow catheter (ThermoCool® catheter). All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.
ThermoCool® catheter: The control group will receive the higher flow catheter (ThermoCool® catheter). All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.
|
|---|---|---|
|
Number of Participants With Hemodynamic, Electrolyte, and Electrophysiologic Derangements
Required electrolyte replacement
|
2 Participants
|
6 Participants
|
|
Number of Participants With Hemodynamic, Electrolyte, and Electrophysiologic Derangements
patients withSystolic BP < 100 mm in CIC
|
1 Participants
|
5 Participants
|
|
Number of Participants With Hemodynamic, Electrolyte, and Electrophysiologic Derangements
sustained atrial tachyarrhythmias
|
0 Participants
|
1 Participants
|
Adverse Events
Low Flow Catheter
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High Flow Catheter
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
Restriction type: OTHER