Trial Outcomes & Findings for Effect of Structural Remodeling on Scar Formation as Assessed by DE-MRI of the Left Atrium (NCT NCT01187914)
NCT ID: NCT01187914
Last Updated: 2012-02-13
Results Overview
Utah staging for fibrosis (I - \<=5%, II - 5.01%-20.0%, III - 20.01%-35% and IV - \>=35.01%)
Recruitment status
COMPLETED
Target enrollment
40 participants
Primary outcome timeframe
Once pre-ablation
Results posted on
2012-02-13
Participant Flow
Patients were recruited based on chart review
Participant milestones
| Measure |
Open Irrigation
Those individuals who had an ablation using open irrigation cooled-tip RF ablation.
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Structural Remodeling on Scar Formation as Assessed by DE-MRI of the Left Atrium
Baseline characteristics by cohort
| Measure |
Open Irrigation
n=40 Participants
Those individuals who had an ablation using open irrigation cooled-tip RF ablation.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
26 Participants
n=5 Participants
|
|
Age Continuous
|
65.2 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Once pre-ablationUtah staging for fibrosis (I - \<=5%, II - 5.01%-20.0%, III - 20.01%-35% and IV - \>=35.01%)
Outcome measures
| Measure |
Open Irrigation
n=40 Participants
Those individuals who had an ablation using open irrigation cooled-tip RF ablation.
|
|---|---|
|
Left Atrial (LA) Remodeling Pre-ablation
Utah stage 1
|
2 participants
|
|
Left Atrial (LA) Remodeling Pre-ablation
Utah stage 2
|
31 participants
|
|
Left Atrial (LA) Remodeling Pre-ablation
Utah stage 3
|
7 participants
|
|
Left Atrial (LA) Remodeling Pre-ablation
Utah stage 4
|
0 participants
|
Adverse Events
Open Irrigation
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
Dr. Kavitha Damal, Clinical research Manager
Arrhythmia Research Center, University of Utah
Phone: 8012133775
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place