The main objective is to investigate mechanical alternans and MTWA in TAVI patients to demonstrate a possible correlation between these two phenomena.
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Presence or absence of mechanical alternans and MTWA.
Secondary outcome
NA
Background summary
In patients with severe heart failure and aortic valve disease, mechanical
alternans or pulsus alternans (a condition in which there is a beat-to-beat
oscillation in the strength of cardiac muscle at a constant heart rate) and
electrical alternans is observed. The mechanisms linking mechanical to
electrophysiological dysfunction in heart failure are still under
investigation, but impaired calcium cycling is the most striking abnormality of
failing myocytes, and is most responsible for contractile dysfunction. Yet it
remains unclear how this influences susceptibility to arrhythmias. The MTWA is
suggested as a risk marker to identify high risk patients for potential VTEs
but the underlying mechanism is not completely understood. The aim of this
study is to investigate this in a clinical setting by measuring LV parameters
using a PV loop conductance catheter and generate TWA recording simultaneously
to demonstrate a possible correlation between these two phenomena in patients
with TAVI and find out if MTWA could turn into a more valuable risk stratifier.
Our hypothesis is that alternating changes in LV filling explain the
electrocardiogenesis of TWA by changing the position of the heart relative to
the body surface electrodes in an alternating way.
Study objective
The main objective is to investigate mechanical alternans and MTWA in TAVI
patients to demonstrate a possible correlation between these two phenomena.
Study design
Observational study of 50 patients.
Study burden and risks
Positioning the condunctance catheter requires up to maximum 1 minute extra
fluoroscopy time. According to the advice of the radiation commitee, this
causes minor risk. The high resolution electrodes could cause skin reactions
such as irritation and itching. The standard procedure will be extended by 20
minutes maximally.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Patients will be included if they are over 18 years and able to give informed consent. Patients are admitted for TAVI.
Exclusion criteria
• Age < 18 years
• Hemodynamically unstable patients
Design
Recruitment
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 | NL41610.018.12 |