Trial Outcomes & Findings for Multipolar Mapping and Atrial Arrhythmias (NCT NCT02307188)
NCT ID: NCT02307188
Last Updated: 2016-03-16
Results Overview
Electrogram signal analysis will be performed to assess the dominant frequency of the atrial fibrillation electrograms collected by this catheter. These values will be correlated to patient outcomes.
COMPLETED
NA
5 participants
1 year
2016-03-16
Participant Flow
Five (5) patients were enrolled. The catheters were used in the left atrium in one (1) patient. The remaining patients were excluded because of subtherapeutic activated clotting time levels \< 300 seconds (3 patients) or presence of prosthetic valve (1 patient).
Participant milestones
| Measure |
Basket Catheter
The Constellation Full Contact Mapping Catheter (multipolar catheter) to be utilized for collection of atrial electrograms.
Constellation Full Contact Mapping Catheter: 64-electrode intracardiac mapping catheter.
Since enrollment began, a total of five (5) patients consented to enrollment in the study during their atrial fibrillation/tachycardia ablation procedures. The catheter (a new catheter was used for each patient) was used in the left atrium in one patient who met all inclusion criteria and did not have any exclusions.
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|---|---|
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Overall Study
STARTED
|
5
|
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Overall Study
COMPLETED
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1
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Overall Study
NOT COMPLETED
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4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multipolar Mapping and Atrial Arrhythmias
Baseline characteristics by cohort
| Measure |
Basket Catheter
n=1 Participants
The Constellation Full Contact Mapping Catheter (multipolar catheter) to be utilized for collection of atrial electrograms.
Constellation Full Contact Mapping Catheter: 64-electrode intracardiac mapping catheter.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
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1 Participants
n=5 Participants
|
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Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
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1 Participants
n=5 Participants
|
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Region of Enrollment
United States
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1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Because the quality of intracardiac electrogram data for the one patient to complete the study was not sufficient for analysis, this outcome measure was not analyzed.
Electrogram signal analysis will be performed to assess the dominant frequency of the atrial fibrillation electrograms collected by this catheter. These values will be correlated to patient outcomes.
Outcome measures
Outcome data not reported
Adverse Events
Basket Catheter
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