Heart Failure
Conditions
Brief summary
The purpose of the study is to assess lead implant success and complication rate using the Medtronic Attain Family of left-heart leads and delivery catheters.
Interventions
DEVICEAttain Success Lead
Attain Success Lead
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is at least 18 years of age or older * Subject will be implanted with Medtronic cardiac resynchronization therapy (CRT) device and Medtronic left heart lead utilizing (or attempting to utilize) Attain Family of delivery catheters. The implant procedure may include upgrades to CRT from implantable pulse generator (IPG) or implantable cardioverter-defibrillator (ICD).
Exclusion criteria
* Subject is enrolled in a concurrent study with the exception of a study approved by the Medtronic Clinical Trial Leader prior to enrollment * Subject has existing CRT system implanted or was previously implanted with a CRT system.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjects Successfully Implanted With an Attain Family Left-heart Lead Using an Attain Family Delivery Catheter | Implant | 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. |
| Subjects Without a Left-heart Lead and Delivery Catheter Related Complication | Implant to 3 months | A 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). |
Countries
Canada, China, France, Germany, Hong Kong, India, Malaysia, Malta, Pakistan, Poland, Puerto Rico, Romania, Singapore, Taiwan, Thailand, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Attain Family Lead Subjects who underwent an Attain Family lead implant after either an Attain Family catheter attempt or any catheter model attempt | 2,014 |
| Total | 2,014 |
Baseline characteristics
| Characteristic | Attain Family Lead |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1353 Participants |
| Age, Categorical Between 18 and 65 years | 661 Participants |
| Age Continuous | 69.1 years STANDARD_DEVIATION 12 |
| Region of Enrollment Canada | 15 participants |
| Region of Enrollment China | 46 participants |
| Region of Enrollment France | 83 participants |
| Region of Enrollment Germany | 6 participants |
| Region of Enrollment Hong Kong | 7 participants |
| Region of Enrollment India | 79 participants |
| Region of Enrollment Malaysia | 12 participants |
| Region of Enrollment Malta | 8 participants |
| Region of Enrollment Pakistan | 11 participants |
| Region of Enrollment Poland | 22 participants |
| Region of Enrollment Puerto Rico | 35 participants |
| Region of Enrollment Romania | 5 participants |
| Region of Enrollment Singapore | 3 participants |
| Region of Enrollment Taiwan | 30 participants |
| Region of Enrollment Thailand | 4 participants |
| Region of Enrollment United States | 1648 participants |
| Sex: Female, Male Female | 576 Participants |
| Sex: Female, Male Male | 1438 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 2,014 |
| serious Total, serious adverse events | 55 / 2,014 |
Outcome results
Primary
Subjects Successfully Implanted With an Attain Family Left-heart Lead Using an Attain Family Delivery Catheter
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.
Time frame: Implant
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Attain Family Lead and Catheter Attempt | Subjects Successfully Implanted With an Attain Family Left-heart Lead Using an Attain Family Delivery Catheter | 1802 participants |
95% CI: [0.929, 0.951]
Primary
Subjects Without a Left-heart Lead and Delivery Catheter Related Complication
A 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).
Time frame: Implant to 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Attain Family Lead and Catheter Attempt | Subjects Without a Left-heart Lead and Delivery Catheter Related Complication | 1895 participants |
95% CI: [0.965, 0.98]