Trial Outcomes & Findings for Lattice-tip Versus Irrigated-tip Catheter for Linear Ablation of the Cavotricuspid Isthmus. A Multicenter, Randomized Study. (NCT NCT07078760)
NCT ID: NCT07078760
Last Updated: 2026-06-17
Results Overview
The primary procedural endpoint for efficacy will be the achievement of bidirectional CTI block after a 60 minute waiting period assessed by high resolution activation mapping and adenosine testing.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
102 participants
Primary outcome timeframe
60 minutes
Results posted on
2026-06-17
Participant Flow
Participant milestones
| Measure |
CTI Radiofrequency Ablation With Lattice-tip Catheter
Patients undergoing CTI catheter ablation using RF energy delivered by the lattice-tip, dual-energy catheter (Sphere-9, Medtronic).
|
CTI Radiofrequency Ablation Performed With Irrigated-tip Catheter
Patients undergoing CTI catheter ablation using RF energy delivered by the irrigated RF catheter (ThermoCool® SmartTouch™, Biosense Webster, USA).
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
51
|
|
Overall Study
COMPLETED
|
51
|
51
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
CTI Radiofrequency Ablation With Lattice-tip Catheter
n=51 Participants
Patients undergoing CTI catheter ablation using RF energy delivered by the lattice-tip, dual-energy catheter (Sphere-9, Medtronic).
|
CTI Radiofrequency Ablation Performed With Irrigated-tip Catheter
n=51 Participants
Patients undergoing CTI catheter ablation using RF energy delivered by the irrigated RF catheter (ThermoCool® SmartTouch™, Biosense Webster, USA).
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.7 years
STANDARD_DEVIATION 10.9 • n=51 Participants
|
65.1 years
STANDARD_DEVIATION 10.4 • n=51 Participants
|
64.4 years
STANDARD_DEVIATION 10.6 • n=102 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=51 Participants
|
18 Participants
n=51 Participants
|
35 Participants
n=102 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=51 Participants
|
33 Participants
n=51 Participants
|
67 Participants
n=102 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 60 minutesThe primary procedural endpoint for efficacy will be the achievement of bidirectional CTI block after a 60 minute waiting period assessed by high resolution activation mapping and adenosine testing.
Outcome measures
| Measure |
Lattice-tip Group
n=51 Participants
Ablation performed with the lattice-tip catheter.
|
Standard Group
n=51 Participants
Ablation performed with the standard 3.5-mm irrigated radiofrequency catheter.
|
|---|---|---|
|
Number of Participants With Achievement of Bidirectional CTI Block After 60 Min Waiting Period Documented by High Resolution Activation Mapping
|
48 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: IntraproceduralyAchievement of bidirectional CTI block upon the completion of the initially deployed CTI line.
Outcome measures
| Measure |
Lattice-tip Group
n=51 Participants
Ablation performed with the lattice-tip catheter.
|
Standard Group
n=51 Participants
Ablation performed with the standard 3.5-mm irrigated radiofrequency catheter.
|
|---|---|---|
|
Number of Participants With First-pass CTI Block
|
46 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: IntraproceduralyTotal ablation time
Outcome measures
| Measure |
Lattice-tip Group
n=51 Participants
Ablation performed with the lattice-tip catheter.
|
Standard Group
n=51 Participants
Ablation performed with the standard 3.5-mm irrigated radiofrequency catheter.
|
|---|---|---|
|
Total Ablation Time
|
41.3 sec
Standard Deviation 12.1
|
245.3 sec
Standard Deviation 91.3
|
SECONDARY outcome
Timeframe: IntraproceduralyOutcome measures
| Measure |
Lattice-tip Group
n=51 Participants
Ablation performed with the lattice-tip catheter.
|
Standard Group
n=51 Participants
Ablation performed with the standard 3.5-mm irrigated radiofrequency catheter.
|
|---|---|---|
|
Number of Ablation Lesions
|
8.3 ablation lesions
Standard Deviation 2.4
|
13.4 ablation lesions
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: From randomization to the end of the index procedureOutcome measures
| Measure |
Lattice-tip Group
n=51 Participants
Ablation performed with the lattice-tip catheter.
|
Standard Group
n=51 Participants
Ablation performed with the standard 3.5-mm irrigated radiofrequency catheter.
|
|---|---|---|
|
Total Fluoroscopy Time
|
2.0 min
Standard Deviation 2.3
|
2.4 min
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: From randomization to the end of the index procedureOutcome measures
| Measure |
Lattice-tip Group
n=51 Participants
Ablation performed with the lattice-tip catheter.
|
Standard Group
n=51 Participants
Ablation performed with the standard 3.5-mm irrigated radiofrequency catheter.
|
|---|---|---|
|
Total Fluoroscopy Dose
|
3.2 Gy.cm2
Standard Deviation 5.2
|
4.2 Gy.cm2
Standard Deviation 9.1
|
Adverse Events
CTI Radiofrequency Ablation With Lattice-tip Catheter
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CTI Radiofrequency Ablation Performed With Irrigated-tip 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