Trial Outcomes & Findings for TOCCATA - Touch+™ for Catheter Ablation (NCT NCT01223469)
NCT ID: NCT01223469
Last Updated: 2019-01-30
Results Overview
For Right SVT patients 7 days (±1 day) following the index procedure or until hospital discharge whichever is longer. For AF patients 3 months (±2 weeks)following the index procedure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
77 participants
Primary outcome timeframe
3 months for AF arm; 7 days for the right SVT arm
Results posted on
2019-01-30
Participant Flow
Participant milestones
| Measure |
Atrial Fibrillation
Contact force assisted irrigated RF ablation: radiofrequency ablation of atrial fibrillation.
|
Right-sided Supraventricular Tachycardia
Contact force assisted irrigated RF ablation: radiofrequency ablation of SVT
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
43
|
|
Overall Study
COMPLETED
|
34
|
43
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TOCCATA - Touch+™ for Catheter Ablation
Baseline characteristics by cohort
| Measure |
Atrial Fibrillation
n=34 Participants
Contact force assisted irrigated RF ablation: radiofrequency ablation of atrial fibrillation.
|
Right-sided Supraventricular Tachycardia
n=43 Participants
Contact force assisted irrigated RF ablation: radiofrequency ablation of SVT
|
Total
n=77 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
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
25 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months for AF arm; 7 days for the right SVT armFor Right SVT patients 7 days (±1 day) following the index procedure or until hospital discharge whichever is longer. For AF patients 3 months (±2 weeks)following the index procedure.
Outcome measures
| Measure |
Atrial Fibrillation
n=34 Participants
Contact force assisted irrigated RF ablation: radiofrequency ablation of atrial fibrillation.
|
Right-sided Supraventricular Tachycardia
n=43 Participants
Contact force assisted irrigated RF ablation: radiofrequency ablation of SVT.
|
|---|---|---|
|
Number of Subjects With Operative and Post-operative Serious Adverse Events
|
4 participants
|
1 participants
|
Adverse Events
Atrial Fibrillation
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Right-sided Supraventricular Tachycardia
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Atrial Fibrillation
n=34 participants at risk
Contact force assisted irrigated RF ablation: radiofrequency ablation of atrial fibrillation.
|
Right-sided Supraventricular Tachycardia
n=43 participants at risk
Contact force assisted irrigated RF ablation: radiofrequency ablation of SVT.
|
|---|---|---|
|
Cardiac disorders
Sinus Bradycardia
|
2.9%
1/34 • Number of events 1
|
2.3%
1/43 • Number of events 1
|
|
Cardiac disorders
Tamponade
|
2.9%
1/34 • Number of events 1
|
0.00%
0/43
|
|
Vascular disorders
Groin Bleeding
|
2.9%
1/34 • Number of events 1
|
0.00%
0/43
|
|
Cardiac disorders
Stroke
|
2.9%
1/34 • Number of events 1
|
0.00%
0/43
|
Other adverse events
Adverse event data not reported
Additional Information
Hendrik Lambert PhD, VP of Clinical and Regulatory Affairs
St. Jude Medical/Endosense
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place