Trial Outcomes & Findings for Pacemaker Therapy in Adults With Congenital Heart Defects (NCT NCT00303511)
NCT ID: NCT00303511
Last Updated: 2014-08-08
Results Overview
The ability to place a pacemaker with capture (have the pacemaker work properly) through totally thoracoscopic approach to epicardial pacing lead without requiring conversion to open procedure
Recruitment status
COMPLETED
Target enrollment
10 participants
Primary outcome timeframe
30 days
Results posted on
2014-08-08
Participant Flow
retrospective chart review
Participant milestones
| Measure |
ACHD With Pacemaker
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pacemaker Therapy in Adults With Congenital Heart Defects
Baseline characteristics by cohort
| Measure |
ACHD With Pacemaker
n=10 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
32.5 years
STANDARD_DEVIATION 5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysThe ability to place a pacemaker with capture (have the pacemaker work properly) through totally thoracoscopic approach to epicardial pacing lead without requiring conversion to open procedure
Outcome measures
| Measure |
Cohort
n=10 Participants
|
|---|---|
|
Feasibility of Pacemaker Implant With Total Thoracoscopic Approach to Epicardial Pacing Lead
|
100 percentage of particiapants
|
Adverse Events
ACHD With Pacemaker
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