An interventional study of ThermoCool® SF NAV Catheter and ThermoCool® catheter in Atrial Fibrillation, sponsored by Wake Forest University Health Sciences. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-03.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Other
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.
Final report
3,869 studies on the registry are indexed under Atrial Fibrillation; 923 are open to participants now.
This study's enrollment of 13 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: ThermoCool® SF NAV 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.
Device: ThermoCool® 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.
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
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
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
| Milestone | Low Flow Catheter | High Flow Catheter |
|---|---|---|
| Started | 4 | 9 |
| Completed | 3 | 9 |
| Not completed | 1 | 0 |
| Withdrew: Screen failure | 1 | 0 |
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
| Participants | Low Flow Catheter | High Flow Catheter |
|---|---|---|
| Required electrolyte replacement | 2 | 6 |
| patients withSystolic BP < 100 mm in CIC | 1 | 5 |
| sustained atrial tachyarrhythmias | 0 | 1 |
Collected over 24 hours post procedure. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Low Flow Catheter | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| High Flow Catheter | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Age, Continuous(years) | Low Flow Catheter | High Flow Catheter | Total |
|---|---|---|---|
| Mean | 61 ± 16.5 | 61.3 ± 9 | 61.23 ± 11.08 |
| Sex: Female, Male(Participants) | Low Flow Catheter | High Flow Catheter | Total |
|---|---|---|---|
| Female | 2 | 3 | 5 |
| Male | 2 | 6 | 8 |
| Region of Enrollment(Participants) | Low Flow Catheter | High Flow Catheter | Total |
|---|---|---|---|
| United States | 4 | 9 | 13 |
| Comorbidities(Participants) | Low Flow Catheter | High Flow Catheter | Total |
|---|---|---|---|
| Hypertension | 2 | 5 | 7 |
| Heart Failure | 2 | 0 | 2 |
| Diabetes | 1 | 2 | 3 |
| Obstructive sleep apnea | 3 | 1 | 4 |
| Coronary artery disease | 2 | 2 | 4 |
| Tobacco history(Participants) | Low Flow Catheter | High Flow Catheter | Total |
|---|---|---|---|
| Count of participants | 0 | 5 | 5 |
| Previous therapies(Participants) | Low Flow Catheter | High Flow Catheter | Total |
|---|---|---|---|
| statin | 2 | 4 | 6 |
| angiotensin 2 receptor blockers | 1 | 2 | 3 |
| angiotensin converting enzymes | 0 | 3 | 3 |
| beta blockers | 2 | 7 | 9 |
| digoxin | 0 | 2 | 2 |
| spiranolactone | 0 | 0 | 0 |
| diuretic | 1 | 0 | 1 |
| CHADsVasc 2 score= 2+(Participants) | Low Flow Catheter | High Flow Catheter | Total |
|---|---|---|---|
| Count of participants | 3 | 9 | 12 |
| prior cardiac surgery(Participants) | Low Flow Catheter | High Flow Catheter | Total |
|---|---|---|---|
| pacemaker | 0 | 1 | 1 |
| coronary artery bypass grafting | 0 | 1 | 1 |
| surgical maze | 0 | 0 | 0 |
| right atrial flutter ablation | 0 | 2 | 2 |
| prior catheter Radiofrequency ablation for Afib | 1 | 2 | 3 |
1 further baseline measures are reported on the registry.
Plan to share: No
This study is terminated, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Wake Forest University Health Sciences