Trial Outcomes & Findings for The Automated Calculation of AF Cycle Length and Complexity Using a Novel EP Recording System (NCT NCT05477602)
NCT ID: NCT05477602
Last Updated: 2026-01-30
Results Overview
Data collected during the study will be used to test an AF cycle length algorithm
Recruitment status
COMPLETED
Target enrollment
21 participants
Primary outcome timeframe
One day - day of procedure
Results posted on
2026-01-30
Participant Flow
Participant milestones
| Measure |
Full Cohort
All patients recruited
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Full Cohort
n=21 Participants
All 21 patients in the PPT group
|
|---|---|
|
Age, Continuous
|
66.29 years
STANDARD_DEVIATION 9.12 • n=21 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=21 Participants
|
|
Weight
|
81.57 kg
STANDARD_DEVIATION 17.71 • n=21 Participants
|
|
Systolic Blood Pressure
|
138.48 mmHg
STANDARD_DEVIATION 21.18 • n=21 Participants
|
|
Diastolic Blood Pressure
|
86.33 mmHg
STANDARD_DEVIATION 12.59 • n=21 Participants
|
|
Heart Rate
|
78.9 BPM
STANDARD_DEVIATION 19.54 • n=21 Participants
|
|
Respiratory Rate
|
16.52 breaths/min
STANDARD_DEVIATION 2.62 • n=21 Participants
|
PRIMARY outcome
Timeframe: One day - day of procedureData collected during the study will be used to test an AF cycle length algorithm
Outcome measures
| Measure |
Full Cohort
n=21 Participants
All enrolled patients
|
|---|---|
|
Measurement of AF Cycle Length
|
171.64 ms
Standard Deviation 27.23
|
Adverse Events
Full Cohort
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Full Cohort
n=21 participants at risk
All patients recruited
|
|---|---|
|
Vascular disorders
Bleeding from the groin
|
4.8%
1/21 • Enrollment until hospital discharge, up to 3 days
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place