The primary objective of the PASSENGER study is to investigate any relationship between changes in SonR1 augmentation and a change in patients* exercise capacity as assessed by the 6 Minute Walk Test.
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of the study is to investigate any relationship between
changes in the SonR1 augmentation and a change in the exercise capacity of CRT
patients as assessed by the 6MWTbetween follow-ups
Secondary outcome
- Assess that for 10 out of the 15 first patients enrolled the data stored in
the SonR histograms can be used to generate an estimate of the SonR
augmentation from rest to exercise;
- Observe, qualitatively, whether the changes in the SonR1 augmentation curve
can be attributed to other measures of functional exercise capacity or cardiac
pathologies;
- Investigate the relationship between SonR1 amplitude, heart rate, respiratory
rate/amplitude and activity level during patients* daily activities;
- Observe, qualitatively, any differences in the change of SonR features with
heart rate between the ischemic and non-ischemic patients;
- Compare the SonR augmentation calculated from the histogram data and that
measured from the raw SonR data;
- Assess the quality of the MV signal recorded using different lead reference,
in different filtering conditions;
- Report all the serious adverse events.
Background summary
Heart failure is a medical condition defined by the inability of the heart to
provide sufficient blood flow to meet the metabolic demand of the body. In many
cases this is due to a lack of synchronization between the contraction of the
left and right ventricles, itself caused by electrical conduction issues such
as left bundle branch block (LBBB). Patients with such a condition may be
eligible for the implantation of a cardiac resynchronization therapy (CRT)
device comprises a stimulator and two or more stimulating electrodes or leads.
The leads are implanted via the vasculature and are located in or adjacent to
the left and right ventricles and often additionally the right atrium. Therapy
is delivered in the form of electrical pulses which cause local depolarization
of the cardiac tissue and ultimately the contraction of the heart.
Resynchronization is achieved by careful selection of the timing of the pulses
which may be set by the implanting physician or, in some cases, derived
automatically.
Study objective
The primary objective of the PASSENGER study is to investigate any relationship
between changes in SonR1 augmentation and a change in patients* exercise
capacity as assessed by the 6 Minute Walk Test.
Study design
European, prospective, single arm multicenter feasibility study
Intervention
During pre-discharge, 6 weeks and 6 month visits patients ave to do a 6 Minute
Walk Test. Also during 6 week visit patients have to do an exercise stress
test.
Study burden and risks
Not applicable
Paasheuvelweg 1
Amsterdam 1105 BE
NL
Paasheuvelweg 1
Amsterdam 1105 BE
NL
Listed location countries
Age
Inclusion criteria
- patients implanted with a CRT-D device according to published relevant ESC guidelines in the last 5 days;
- patients implanted with an Implantable cardioverter defibrillator (CRT-D) device equipped with SonR technology;
- patients implanted with a SonRtip tm right atrial lead;
- patients in sinus rhythm;
- patients on stable medical therapies regimen;
- patients capable to perform stress test;
- patients reviewed, sign and dated an informed consent form
Exclusion criteria
patients with:
- persistent atrial arrhythmias within the past three months;
- unstable angina or acure MI within the past 3 months;
- already included in another clinical study that could confound the results of this study
- pregnancy;
- vulnerable subjects as defined in ISO 14155:2011;
- unavailability for scheduled follow-up or refusal to cooperate
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 | NL48753.028.14 |