Trial Outcomes & Findings for Isthmus Ablation With Gold Electrode for Treatment of Atrial Flutter (AURUM 8) (NCT NCT00326001)
NCT ID: NCT00326001
Last Updated: 2010-02-18
Results Overview
Cumulative amount of time current is flowing through the catheter tip. The current (in the radiofrequency range) is applied to ablate the cavotricuspid isthmus in the right atrium.
COMPLETED
PHASE4
463 participants
ablation procedure
2010-02-18
Participant Flow
A total of 463 patients were enrolled in the AURUM 8 study from June 2004 to March 2007 in 19 clinical centers in Germany and the Czech Republic.
No exclusion before assignment
Participant milestones
| Measure |
Gold Tip Catheter
Patients allocated to be ablated by 8-mm gold tip catheter
|
Pt-Ir Tip Catheter
Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
|
|---|---|---|
|
Overall Study
STARTED
|
236
|
227
|
|
Overall Study
COMPLETED
|
229
|
219
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
Reasons for withdrawal
| Measure |
Gold Tip Catheter
Patients allocated to be ablated by 8-mm gold tip catheter
|
Pt-Ir Tip Catheter
Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
5
|
|
Overall Study
Physician Decision
|
3
|
3
|
Baseline Characteristics
Isthmus Ablation With Gold Electrode for Treatment of Atrial Flutter (AURUM 8)
Baseline characteristics by cohort
| Measure |
Gold Tip Catheter
n=236 Participants
Patients allocated to be ablated by 8-mm gold tip catheter
|
Pt-Ir Tip Catheter
n=227 Participants
Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
|
Total
n=463 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
97 Participants
n=99 Participants
|
92 Participants
n=107 Participants
|
189 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
139 Participants
n=99 Participants
|
135 Participants
n=107 Participants
|
274 Participants
n=206 Participants
|
|
Age Continuous
|
66 years
STANDARD_DEVIATION 10 • n=99 Participants
|
66 years
STANDARD_DEVIATION 11 • n=107 Participants
|
66 years
STANDARD_DEVIATION 11 • n=206 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
191 Participants
n=99 Participants
|
192 Participants
n=107 Participants
|
383 Participants
n=206 Participants
|
|
Region of Enrollment
Czech Republic
|
9 participants
n=99 Participants
|
8 participants
n=107 Participants
|
17 participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
227 participants
n=99 Participants
|
219 participants
n=107 Participants
|
446 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: ablation procedurePopulation: Per protocol
Cumulative amount of time current is flowing through the catheter tip. The current (in the radiofrequency range) is applied to ablate the cavotricuspid isthmus in the right atrium.
Outcome measures
| Measure |
Gold Tip Catheter
n=229 Participants
Patients allocated to be ablated by 8-mm gold tip catheter
|
Pt-Ir Tip Catheter
n=219 Participants
Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
|
|---|---|---|
|
Duration of Energy Application
|
10.2 minute
Standard Deviation 6.9
|
10.9 minute
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: ablation procedurePopulation: per protocol
Delivery of radiofrequency current was repeated until a cavotricuspid isthmus (CTI) conduction block was detected. The final bidirectional CTI block test (well documented in the literature) was performed 20 minutes after the last radiofrequency current delivery to assess ablation success (Y/N). Positive final bidirectional cavotricuspid isthmus condution block test means "ablation successful". Negative final bidirectional cavotricuspid isthmus condution block test means "ablation unsuccessful"; ablation should be continued until success or terminated and classified as unsuccess.
Outcome measures
| Measure |
Gold Tip Catheter
n=229 Participants
Patients allocated to be ablated by 8-mm gold tip catheter
|
Pt-Ir Tip Catheter
n=219 Participants
Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
|
|---|---|---|
|
Ablation Success With the First Catheter
|
216 Patients
|
195 Patients
|
SECONDARY outcome
Timeframe: 6 months after ablationPopulation: per protocol
No recurrence of atrial flutter after ablation
Outcome measures
| Measure |
Gold Tip Catheter
n=229 Participants
Patients allocated to be ablated by 8-mm gold tip catheter
|
Pt-Ir Tip Catheter
n=219 Participants
Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
|
|---|---|---|
|
Number of Patients With Long-term Treatment Success
|
225 Patients
|
213 Patients
|
SECONDARY outcome
Timeframe: ablation procedurePopulation: per protocol
Char or coagulum formation on the catheter tip
Outcome measures
| Measure |
Gold Tip Catheter
n=229 Participants
Patients allocated to be ablated by 8-mm gold tip catheter
|
Pt-Ir Tip Catheter
n=219 Participants
Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
|
|---|---|---|
|
Number of Patients With Charred Catheter Tips
|
11 Patients
|
83 Patients
|
Adverse Events
Gold Tip Catheter
Pt-Ir Tip Catheter
Serious adverse events
| Measure |
Gold Tip Catheter
n=229 participants at risk
Patients allocated to be ablated by 8-mm gold tip catheter
|
Pt-Ir Tip Catheter
n=219 participants at risk
Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
|
|---|---|---|
|
General disorders
Death
|
0.87%
2/229 • Number of events 2
|
0.46%
1/219 • Number of events 1
|
|
General disorders
Hospitalization
|
7.9%
18/229 • Number of events 18
|
5.5%
12/219 • Number of events 12
|
Other adverse events
Adverse event data not reported
Additional Information
Dejan Danilovic
Biotronik GmbH&Co. KG, Berlin, Germany
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place