The objective of this study is to collect clinical data on safety and performance of ACUITY X4 leads when used outside a clinical trial in a standard clinical setting.
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints:
- PNS-related Complication-Free Rate (CFR) through 6 months post-implant
- Lead-related Complication-Free Rate (CFR) from Implant through 3 months
post-implant
Secondary outcome
Secondary endpoints;
- All-cause mortality of the enrolled subject population
- Hospitalization rate due to decompensated heart failure in the enrolled
subject population
- Lead related CFR from 3 months through 15 months post-implant
- LV-lead pacing threshold and electrical lead performance in mid to basal
pacing position
- LV-lead pacing threshold and electrical lead performance for pre-specified /
stipulated electrodes
- All-cause operative system revision
- Markers of LV remodelling: distal electrode sensing amplitude and Q-E1, Q-E2
delay
- All alerts which occurred in devices connected with LATITUDE will be compared
with reported adverse events
- LATITUDE alerts and reported adverse events will be compared with recorded
diagnostic data which are available at the same time
Background summary
Implantation of pacing and defibrillation devices that provide cardiac
resynchronization therapy (CRT) is a proven highly effective treatment for
selected subjects with heart failure. Stable and accurate placement of a left
ventricular lead is improves delivery success rate of CRT. The ACUITY family of
leads, as compared to prior LV lead generations, provide the physician with
additional lead placement flexibility and pacing performance choice due to
their smaller size and variety of shapes and electrode spacing. These lead
designs enable the pacing electrode to remain fixed in more proximal locations
and the inclusion of 4 discrete electrodes allows for multiple LV pacing
configurations. It is expected that this will lower the risk of phrenic nerve
stimulation (PNS). It is also expected to mitigate against higher LV
thresholds, which leads to more optimal battery longevity.
Study objective
The objective of this study is to collect clinical data on safety and
performance of ACUITY X4 leads when used outside a clinical trial in a standard
clinical setting.
Study design
This study is prospective, non-randomized, non-blinded observational
multicenter study. Eight hundred to 1000 subjects will be enrolled in this
study and followed for a maximum of 30 months. All study data will be collected
during the regular standard of care patient visits.
Study burden and risks
This is an observational study. The patients will not be subjected to
additional procedures, will not have to be interviewed or complete any
questionnaires, and no specific conduct will be imposed on them, other than is
necessary for the standard treatment of the patient. There will be no
additional patient visits, the trial data will be collected during the regular
visits to the hospital. Risks and burden for the patient will be the same as
risks and burden for patients who receive similar treatment, outside of the
study.
Hamline Avenue North 4100
St. Paul MN55112
US
Hamline Avenue North 4100
St. Paul MN55112
US
Listed location countries
Age
Inclusion criteria
- Subject is willind and capable of providing informed consent
- Subject is planned to be implanted with an ACUITY X$ lead for left-ventricular pacing and sensing via the coronary venous system in conjunction with a compatible BSC pulse generator
- Subject is willing and capable of participating in all visits associated with this study at an approved clinical study center and at the intervals defined by this CIP
- Subject os age 18 or above, or of legal age to give informed consent specific to state and national law
Exclusion criteria
- Subjects with a hypersensitivity to a maximum single dose of 0.51 mg dexamethasone acetate
- Subject is enrolled in any other concurrent study without prior written approval from BSC, with the exception of local mandatory governmental registries and observational studies/registries that are not in conflict and do not affect the following:
* schedule of procedures for the Rally X4 Study (i.e. should not cause additional or missed visits);
* Rally X4 Study outcome (i.e. involve medications that could affect the heart rate of the subject);
* Conduct of the Rally X4 study per GCP/ISO 14155:2011 / local regulations as applicable
- Per the implanting physician's discretion, the subject is not a sauitable candidate to receive the study device as determined during the implant procedure
- Women of childbearing potential who are or might be pregnant at the time of study enrollment
- Subject is unwillingor unable to participate in all scheduled study follow up visits at an approved study center
- Subject does not anticipate being a resident of the area for the scheduled duration of the trial
- Subject's physician does not allow participation
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 | NL47828.075.14 |