The purpose of this clinical study is to evaluate the safety and efficacy of the Attain Stability Quad MRI SureScan LV lead (Model 4798) in patients indicated for a de novo LV lead implant. This will be assessed through primary safety and primary…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Safety Objective: Lead complication-free rate at 6 months
Primary Efficacy Objectives: Lead pacing capture thresholds at 6 months
Secondary outcome
The secondary objectives are descriptive in nature and are intended to provide
additional information about the Attain Stability Quad Model 4798 LV lead.
Background summary
The Attain Stability Quad MRI SureScan 4798 steroid-eluting, quadripolar
electrode, IS4 transvenous lead is indicated for chronic pacing in the left
ventricle via the cardiac vein, when used with a compatible Medtronic Cardiac
Resynchronization Therapy (CRT) system. Extended bipolar pacing is available
using this lead in combination with a compatible market approved CRT-D system
and RV defibrillation lead.
Study objective
The purpose of this clinical study is to evaluate the safety and efficacy of
the Attain Stability Quad MRI SureScan LV lead (Model 4798) in patients
indicated for a de novo LV lead implant. This will be assessed through primary
safety and primary efficacy endpoints.
Study design
The Attain Stability Quad Clinical Study is a prospective, non-randomized,
multi-site, global, Investigational Device Exemption (IDE) interventional
clinical study.
Intervention
All subjects included in the study will be implanted with a Medtronic market
released de novo CRT-P or CRT-D device and an Attain Stability Quad MRI
SureScan LV Lead (Model 4798).
Study burden and risks
The risks are comparable to any other market-released LV lead implant.
Endepolsdomein 5
Maastricht 6229 GW
NL
Endepolsdomein 5
Maastricht 6229 GW
NL
Listed location countries
Age
Inclusion criteria
- Patient meets CRT implant criteria as determined by local regulatory and/or hospital policy.
- Patient has signed and dated the study-specific Consent Form
Exclusion criteria
- Patient has had a previous unsuccessful LV lead implant attempt.
- Patient has an existing epicardial LV lead
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL61223.100.17 |
| Other | will follow later |