Atrial Fibrillation
Conditions
Keywords
Radiofrequency Catheter Ablation, Atrial Fibrillation
Brief summary
This study examined data elements of hemodynamic, electrophysiologic and electrolyte trends comparing 2 different types of catheters used during a procedure to treat medication resistant atrial fibrillation-radiofrequency catheter ablation. A high flow catheter delivers a high volume of saline during the procedure. The low flow catheter delivers a low volume of saline during the procedure. The patient will be consented and randomized to one of the 2 groups using a computer generated randomization chart. Those that are put in the low flow catheter group will be considered the experimental group. All data will be collected before and after the procedure and each patient will act as their own control within each group.
Detailed description
Final report
Interventions
DEVICEThermoCool® 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.
DEVICEThermoCool® 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.
Sponsors
Biosense Webster, Inc.
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Drug resistant paroxysmal AF * ≥ 18 years old
Exclusion criteria
* Left atrial thrombus on TEE * Patients unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Hemodynamic, Electrolyte, and Electrophysiologic Derangements | Observation period is up to the 24 hours post procedure | 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 |
Countries
United States
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 4 |
| 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. | 9 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | screen failure | 1 | 0 |
Baseline characteristics
| Characteristic | Low Flow Catheter | High Flow Catheter | Total |
|---|---|---|---|
| Age, Continuous | 61 years STANDARD_DEVIATION 16.5 | 61.3 years STANDARD_DEVIATION 9 | 61.23 years STANDARD_DEVIATION 11.08 |
| CHADsVasc 2 score= 2+ | 3 Participants | 9 Participants | 12 Participants |
| Comorbidities Coronary artery disease | 2 Participants | 2 Participants | 4 Participants |
| Comorbidities Diabetes | 1 Participants | 2 Participants | 3 Participants |
| Comorbidities Heart Failure | 2 Participants | 0 Participants | 2 Participants |
| Comorbidities Hypertension | 2 Participants | 5 Participants | 7 Participants |
| Comorbidities Obstructive sleep apnea | 3 Participants | 1 Participants | 4 Participants |
| Previous therapies angiotensin 2 receptor blockers | 1 Participants | 2 Participants | 3 Participants |
| Previous therapies angiotensin converting enzymes | 0 Participants | 3 Participants | 3 Participants |
| Previous therapies beta blockers | 2 Participants | 7 Participants | 9 Participants |
| Previous therapies digoxin | 0 Participants | 2 Participants | 2 Participants |
| Previous therapies diuretic | 1 Participants | 0 Participants | 1 Participants |
| Previous therapies spiranolactone | 0 Participants | 0 Participants | 0 Participants |
| Previous therapies statin | 2 Participants | 4 Participants | 6 Participants |
| Prior Antiarrhythmia drug failure ammiodarone and dronedarone | 0 Participants | 1 Participants | 1 Participants |
| Prior Antiarrhythmia drug failure ammiodarone and fleccainide | 1 Participants | 0 Participants | 1 Participants |
| Prior Antiarrhythmia drug failure dofetilide | 0 Participants | 1 Participants | 1 Participants |
| Prior Antiarrhythmia drug failure dronedarone | 1 Participants | 3 Participants | 4 Participants |
| Prior Antiarrhythmia drug failure fleccainide | 0 Participants | 2 Participants | 2 Participants |
| Prior Antiarrhythmia drug failure none | 0 Participants | 1 Participants | 1 Participants |
| Prior Antiarrhythmia drug failure sotolol | 1 Participants | 1 Participants | 2 Participants |
| prior cardiac surgery coronary artery bypass grafting | 0 Participants | 1 Participants | 1 Participants |
| prior cardiac surgery pacemaker | 0 Participants | 1 Participants | 1 Participants |
| prior cardiac surgery prior catheter Radiofrequency ablation for Afib | 1 Participants | 2 Participants | 3 Participants |
| prior cardiac surgery right atrial flutter ablation | 0 Participants | 2 Participants | 2 Participants |
| prior cardiac surgery surgical maze | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 4 Participants | 9 Participants | 13 Participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Male | 2 Participants | 6 Participants | 8 Participants |
| Tobacco history | 0 Participants | 5 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 9 |
| other Total, other adverse events | 0 / 4 | 0 / 9 |
| serious Total, serious adverse events | 0 / 4 | 0 / 9 |
Outcome results
Primary
Number of Participants With Hemodynamic, Electrolyte, and Electrophysiologic Derangements
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
Time frame: Observation period is up to the 24 hours post procedure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Low Flow Catheter | Number of Participants With Hemodynamic, Electrolyte, and Electrophysiologic Derangements | Required electrolyte replacement | 2 Participants |
| Low Flow Catheter | Number of Participants With Hemodynamic, Electrolyte, and Electrophysiologic Derangements | patients withSystolic BP < 100 mm in CIC | 1 Participants |
| Low Flow Catheter | Number of Participants With Hemodynamic, Electrolyte, and Electrophysiologic Derangements | sustained atrial tachyarrhythmias | 0 Participants |
| High Flow Catheter | Number of Participants With Hemodynamic, Electrolyte, and Electrophysiologic Derangements | Required electrolyte replacement | 6 Participants |
| High Flow Catheter | Number of Participants With Hemodynamic, Electrolyte, and Electrophysiologic Derangements | patients withSystolic BP < 100 mm in CIC | 5 Participants |
| High Flow Catheter | Number of Participants With Hemodynamic, Electrolyte, and Electrophysiologic Derangements | sustained atrial tachyarrhythmias | 1 Participants |