See protocol page 12The purpose of this clinical study is to evaluate the safety and efficacy of the Micra Transcatheter Pacing system and to assess long-term device performance.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
See protocol page 22-24, 84-95
Primary Objectives:
• Demonstrate that the freedom from acute major complications related to the
Micra system and/or procedure at 6 months post-implant is greater than 83%
• Demonstrate that the percentage of subjects with an adequate pacing capture
threshold at 6-months post-implant exceeds 80%.
Secondary outcome
See protocol page 24, 95-100
Secondary Objectives:
• Demonstrate the accuracy of Micra ventricular capture management pacing
thresholds compared to manual pacing capture thresholds.
• Demonstrate the rate response operation of the Micra system.
Background summary
See protocol page 13, 14
Pacemaker treatment remains the only known, long term effective treatment for
bradycardia. Since their introduction in the 1960s, pacemakers have steadily
shrunk in size and grown in sophistication. Technology advances have now made
it possible for Medtronic to develop a device small enough to implant within
the heart while still providing similar battery longevity.
Conventional pacing systems consist of a pacemaker device and one or more leads
from the device pocket through veins into the heart. The Micra Transcatheter
Pacing System is a miniaturized single chamber pacemaker system that is
implanted directly inside the right ventricle of the heart, thereby
potentially eliminating complications associated with traditional pacing
systems.
Study objective
See protocol page 12
The purpose of this clinical study is to evaluate the safety and efficacy of
the Micra Transcatheter Pacing system and to assess long-term device
performance.
Study design
See protocol page 22
The Micra Transcatheter Pacing Study is a world-wide, multi-site, prospective,
single-arm clinical trial.
After implant, subjects are followed at pre-hospital discharge, one month,
three months, six months and every six months thereafter until official study
closure (plan 5 years).
Up to 780 patents enrolled to implant 720 patients from up to 70 worldwide
sites.
The study includes several analysis; CE analysis, interim analysis, final
analysis, long-term analysis.
Intervention
- Implantation of a leadless single chamber pacemaker (Micra transcatheter
Pacing System)
Study burden and risks
The risks are similar to those of a standard implantation of a single-chamber
pacemaker. There are some risks that are not applicable for the Micra pacemaker
such as problems associated with the lead and pocket. However, there are also a
number of potential new risks associated with the implantation procedure and
the Micra pacemaker;
- Vessel spasm
- Peripheral ischemia
- (psuedo) aneurysm
- Heart tissue damage due to fixation of the Micra
- Coronary arterial constriction
- Risk of arterio-venous fistula
- Device dislocation
- Device embolization
For an extensive overview see protocol page 75-79
Earl Bakkenstraat 10
Heerlen 6422 PJ
NL
Earl Bakkenstraat 10
Heerlen 6422 PJ
NL
Listed location countries
Age
Inclusion criteria
Subjects who have a Class I or II indication for implantation of a single chamber pacemaker according to ACC/AHA/HRS 2008 guidelines and any national guidelines.
Exclusion criteria
Subjects who are entirely pacemaker dependent (escape rhythm <30 bpm).
**NOTE: After the 1st 25 usable 1-month holters, the steering committee will conduct a safety review and assess whether this criterion can be removed.
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 | NL45259.060.13 |
| Other | Nog niet bekend |