Trial Outcomes & Findings for Attain Success Clinical Trial (NCT NCT00990964)
NCT ID: NCT00990964
Last Updated: 2012-09-12
Results Overview
Implant success was defined as final successful placement of the Attain Family left-heart lead in the coronary vein branches utilizing the Attain Family of delivery catheters.
Recruitment status
COMPLETED
Target enrollment
2014 participants
Primary outcome timeframe
Implant
Results posted on
2012-09-12
Participant Flow
Participant milestones
| Measure |
Attain Family Left Heart Lead
Subjects who underwent an Attain Family lead implant after either an Attain Family catheter attempt or any catheter model attempt
|
|---|---|
|
Overall Study
STARTED
|
2014
|
|
Overall Study
Attain Family Study System Attempt
|
1917
|
|
Overall Study
COMPLETED
|
1802
|
|
Overall Study
NOT COMPLETED
|
212
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Attain Success Clinical Trial
Baseline characteristics by cohort
| Measure |
Attain Family Lead
n=2014 Participants
Subjects who underwent an Attain Family lead implant after either an Attain Family catheter attempt or any catheter model attempt
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
661 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1353 Participants
n=5 Participants
|
|
Age Continuous
|
69.1 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
576 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1438 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1648 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
30 participants
n=5 Participants
|
|
Region of Enrollment
Hong Kong
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Pakistan
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Thailand
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Malta
|
8 participants
n=5 Participants
|
|
Region of Enrollment
India
|
79 participants
n=5 Participants
|
|
Region of Enrollment
France
|
83 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
15 participants
n=5 Participants
|
|
Region of Enrollment
Puerto Rico
|
35 participants
n=5 Participants
|
|
Region of Enrollment
Malaysia
|
12 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
22 participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
6 participants
n=5 Participants
|
|
Region of Enrollment
China
|
46 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: ImplantImplant success was defined as final successful placement of the Attain Family left-heart lead in the coronary vein branches utilizing the Attain Family of delivery catheters.
Outcome measures
| Measure |
Attain Family Lead and Catheter Attempt
n=1917 Participants
Subjects who were attempted with an Attain Family left-heart lead after successful coronary sinus (CS) cannulation with an Attain Family catheter were included in this analysis as well as subjects who had unsuccessful CS cannulation with an Attain Family delivery catheter.
|
|---|---|
|
Subjects Successfully Implanted With an Attain Family Left-heart Lead Using an Attain Family Delivery Catheter
|
1802 participants
Interval 0.929 to 0.95
|
PRIMARY outcome
Timeframe: Implant to 3 monthsA left-heart lead and delivery related complication was defined as a complication, an adverse event that resulted in death, any termination of significant device function or invasive intervention, that resulted from the presence of or performance (intended or otherwise) of the Medtronic left-heart lead or Attain Family of delivery catheters. All adverse events were adjudicated by an Adverse Event Advisory Committee (AEAC).
Outcome measures
| Measure |
Attain Family Lead and Catheter Attempt
n=1944 Participants
Subjects who were attempted with an Attain Family left-heart lead after successful coronary sinus (CS) cannulation with an Attain Family catheter were included in this analysis as well as subjects who had unsuccessful CS cannulation with an Attain Family delivery catheter.
|
|---|---|
|
Subjects Without a Left-heart Lead and Delivery Catheter Related Complication
|
1895 participants
|
Adverse Events
Attain Family Lead
Serious events: 55 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Attain Family Lead
n=2014 participants at risk
All new and/or worsening adverse events related to the left-heart leads and left-heart lead delivery catheters were collected through the 3 month visit. Event collection started once the subject enrolled in the study and underwent a left-heart lead implant attempt.
|
|---|---|
|
Cardiac disorders
Cardiac Arrest
|
0.05%
1/2014 • Number of events 1 • Implant to 3 month visit.
All new and/or worsening adverse events related to the left heart leads and left heart delivery catheters were collected through the 3 month visit. Event collection began when the subject was enrolled in the study and underwent a left-heart lead implant attempt.
|
|
Cardiac disorders
Cardiac tamponade
|
0.05%
1/2014 • Number of events 1 • Implant to 3 month visit.
All new and/or worsening adverse events related to the left heart leads and left heart delivery catheters were collected through the 3 month visit. Event collection began when the subject was enrolled in the study and underwent a left-heart lead implant attempt.
|
|
Vascular disorders
Deep vein thrombosis
|
0.05%
1/2014 • Number of events 1 • Implant to 3 month visit.
All new and/or worsening adverse events related to the left heart leads and left heart delivery catheters were collected through the 3 month visit. Event collection began when the subject was enrolled in the study and underwent a left-heart lead implant attempt.
|
|
Injury, poisoning and procedural complications
Device capturing issue
|
0.10%
2/2014 • Number of events 2 • Implant to 3 month visit.
All new and/or worsening adverse events related to the left heart leads and left heart delivery catheters were collected through the 3 month visit. Event collection began when the subject was enrolled in the study and underwent a left-heart lead implant attempt.
|
|
Injury, poisoning and procedural complications
Device connection issue
|
0.05%
1/2014 • Number of events 1 • Implant to 3 month visit.
All new and/or worsening adverse events related to the left heart leads and left heart delivery catheters were collected through the 3 month visit. Event collection began when the subject was enrolled in the study and underwent a left-heart lead implant attempt.
|
|
Injury, poisoning and procedural complications
Device dislocation
|
1.4%
29/2014 • Number of events 29 • Implant to 3 month visit.
All new and/or worsening adverse events related to the left heart leads and left heart delivery catheters were collected through the 3 month visit. Event collection began when the subject was enrolled in the study and underwent a left-heart lead implant attempt.
|
|
Injury, poisoning and procedural complications
Device pacing issue
|
0.10%
2/2014 • Number of events 2 • Implant to 3 month visit.
All new and/or worsening adverse events related to the left heart leads and left heart delivery catheters were collected through the 3 month visit. Event collection began when the subject was enrolled in the study and underwent a left-heart lead implant attempt.
|
|
Injury, poisoning and procedural complications
Device stimulation issue
|
0.40%
8/2014 • Number of events 8 • Implant to 3 month visit.
All new and/or worsening adverse events related to the left heart leads and left heart delivery catheters were collected through the 3 month visit. Event collection began when the subject was enrolled in the study and underwent a left-heart lead implant attempt.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.05%
1/2014 • Number of events 1 • Implant to 3 month visit.
All new and/or worsening adverse events related to the left heart leads and left heart delivery catheters were collected through the 3 month visit. Event collection began when the subject was enrolled in the study and underwent a left-heart lead implant attempt.
|
|
Infections and infestations
Implant site infection
|
0.20%
4/2014 • Number of events 4 • Implant to 3 month visit.
All new and/or worsening adverse events related to the left heart leads and left heart delivery catheters were collected through the 3 month visit. Event collection began when the subject was enrolled in the study and underwent a left-heart lead implant attempt.
|
|
Injury, poisoning and procedural complications
Implant site irritation
|
0.05%
1/2014 • Number of events 1 • Implant to 3 month visit.
All new and/or worsening adverse events related to the left heart leads and left heart delivery catheters were collected through the 3 month visit. Event collection began when the subject was enrolled in the study and underwent a left-heart lead implant attempt.
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.05%
1/2014 • Number of events 1 • Implant to 3 month visit.
All new and/or worsening adverse events related to the left heart leads and left heart delivery catheters were collected through the 3 month visit. Event collection began when the subject was enrolled in the study and underwent a left-heart lead implant attempt.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.05%
1/2014 • Number of events 1 • Implant to 3 month visit.
All new and/or worsening adverse events related to the left heart leads and left heart delivery catheters were collected through the 3 month visit. Event collection began when the subject was enrolled in the study and underwent a left-heart lead implant attempt.
|
|
Cardiac disorders
Sudden cardiac death
|
0.05%
1/2014 • Number of events 1 • Implant to 3 month visit.
All new and/or worsening adverse events related to the left heart leads and left heart delivery catheters were collected through the 3 month visit. Event collection began when the subject was enrolled in the study and underwent a left-heart lead implant attempt.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.10%
2/2014 • Number of events 2 • Implant to 3 month visit.
All new and/or worsening adverse events related to the left heart leads and left heart delivery catheters were collected through the 3 month visit. Event collection began when the subject was enrolled in the study and underwent a left-heart lead implant attempt.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place