Trial Outcomes & Findings for NeoChord TACT Post-Market Surveillance Registry (NCT NCT01784055)
NCT ID: NCT01784055
Last Updated: 2018-04-02
Results Overview
To describe the rate of subjects with at least one neochord placed using the DS1000 System AND a reduction in mitral regurgitation ≤ 2+ at the time of the procedure
Recruitment status
COMPLETED
Target enrollment
126 participants
Primary outcome timeframe
The patient will be evaluated from the procedure through the hospital discharge. Approximately 1 day.
Results posted on
2018-04-02
Participant Flow
Participant milestones
| Measure |
Overall
All Subjects
|
|---|---|
|
Overall Study
STARTED
|
126
|
|
Overall Study
COMPLETED
|
100
|
|
Overall Study
NOT COMPLETED
|
26
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One patient did not have baseline information reported
Baseline characteristics by cohort
| Measure |
Overall
n=126 Participants
All subjects
|
|---|---|
|
Age, Continuous
|
66 years
STANDARD_DEVIATION 14 • n=125 Participants • One patient did not have baseline information reported
|
|
Sex: Female, Male
Female
|
34 Participants
n=125 Participants • One patient did not have baseline information reported
|
|
Sex: Female, Male
Male
|
91 Participants
n=125 Participants • One patient did not have baseline information reported
|
PRIMARY outcome
Timeframe: The patient will be evaluated from the procedure through the hospital discharge. Approximately 1 day.To describe the rate of subjects with at least one neochord placed using the DS1000 System AND a reduction in mitral regurgitation ≤ 2+ at the time of the procedure
Outcome measures
| Measure |
Overall
n=126 Participants
All patients
|
|---|---|
|
Procedure Success
>1 neochord placed and MR</= 2+
|
121 Participants
|
|
Procedure Success
No neochords placed or MR>/=3+
|
5 Participants
|
Adverse Events
Overall
Serious events: 37 serious events
Other events: 9 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Overall
n=126 participants at risk
All patients
|
|---|---|
|
Cardiac disorders
Regurgitation
|
1.6%
2/126 • Number of events 2 • Index procedure though 1-year follow-up visit
|
|
General disorders
Dyspnea
|
1.6%
2/126 • Number of events 3 • Index procedure though 1-year follow-up visit
|
|
Hepatobiliary disorders
Hepatic complication
|
0.79%
1/126 • Number of events 1 • Index procedure though 1-year follow-up visit
|
|
Infections and infestations
Infection
|
2.4%
3/126 • Number of events 3 • Index procedure though 1-year follow-up visit
|
|
Injury, poisoning and procedural complications
Procedural complication
|
4.8%
6/126 • Number of events 6 • Index procedure though 1-year follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
0.79%
1/126 • Number of events 1 • Index procedure though 1-year follow-up visit
|
|
Nervous system disorders
Neurological complication
|
2.4%
3/126 • Number of events 3 • Index procedure though 1-year follow-up visit
|
|
Renal and urinary disorders
Renal dysfunction
|
3.2%
4/126 • Number of events 4 • Index procedure though 1-year follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory complication
|
3.2%
4/126 • Number of events 7 • Index procedure though 1-year follow-up visit
|
|
Surgical and medical procedures
Valve intervention
|
10.3%
13/126 • Number of events 14 • Index procedure though 1-year follow-up visit
|
|
Vascular disorders
Peripheral vascular complication
|
1.6%
2/126 • Number of events 2 • Index procedure though 1-year follow-up visit
|
|
Cardiac disorders
Other cardiac complication
|
11.9%
15/126 • Number of events 19 • Index procedure though 1-year follow-up visit
|
|
General disorders
Other non-cardiovascular complication
|
1.6%
2/126 • Number of events 3 • Index procedure though 1-year follow-up visit
|
Other adverse events
| Measure |
Overall
n=126 participants at risk
All patients
|
|---|---|
|
Cardiac disorders
Regurgitation
|
7.1%
9/126 • Number of events 9 • Index procedure though 1-year follow-up visit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place