Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06100757 |
| Other study ID # |
S59717 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2018 |
| Est. completion date |
December 31, 2021 |
Study information
| Verified date |
October 2023 |
| Source |
Universitaire Ziekenhuizen KU Leuven |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This prospective, un-blinded, randomized, noninferiority, single centre study with 12 month
follow-up included patients who were scheduled for a single-chamber PM implant. Patients were
1:1 randomized to undergo the implantation of a conventional VVI pacing system (Medtronic,
Advisa ADSR03) with a ventricular pacing lead (Medtronic, 5076-58) in the right ventricle
(called 'conventional group') or to be implanted with a leadless Micra TPS (called 'Micra
group').
The primary objective was to assess and compare the mechanical impact of right ventricular
pacing using the Micra TPS versus a conventional PM on the left ventricular function.
Description:
The primary endpoint was to assess the mechanical impact of the Micra TPS on the left
ventricular function. The investigators measured the change of Global Longitudinal Strain
(GLS) over one year after pacemaker implantation.
As secondary endpoint, the investigators studied the effect of the Micra TPS on the right
ventricle using speckle tracking for 2-D myocardial motion estimation. The investigators also
assessed conventionally the function of the right ventricle using tricuspid annular plane
systolic excursion (TAPSE) in accordance with the guidelines of the European Association of
Cardiovascular Imaging and American Society of Echocardiography. Evolution of clinical and
biological parameters as NYHA (New York Heart Association) classification, '6 minutes 'walk
distance and measurement of brain natriuretic peptide (NT-proBNP) test was also be performed
at baseline and after one year follow-up.
Design
It was an interventional prospective not blinded randomized single centre study. The
investigators randomized fifty patients into two groups (1:1 ratio) between May 2018 and
December 2021:
Group 1 : 25 patients underwent the implantation of a conventional ventricular pacemaker
(Medtronic) with placement of a ventricular lead Medtronic 5076-58 in the right ventricle.
Group 2 : 25 patients underwent the implantation of a leadless pacing system Micra TPS.
All implantation procedures were performed under local anaesthesia. To minimize the impact of
the pacing site, the investigators targeted as first position the mid septum of the right
ventricle. In the presence of inacceptable electrical measurements, an apical positioning was
reached. All pacing positions were reviewed according to the Lieberman criteria.
Patients follow-up Patients were followed for a minimal period of 1 year (at 1 month after
implantation, 6 months and 12 months as in routine care). Two-dimensional echocardiography
was performed 1 day before implantation and at each visit. A 6 minutes' walk distance was
performed at day 10 and at 1 year follow-up. As biological marker of the left ventricular
function, brain natriuretic peptide (NT-proBNP) was also measured at baseline and at 1 year
follow-up.
Device data collections:
The implant procedure duration as the procedure fluoroscopy times were also recorded.
Follow-up of the electrical measurements was performed at the same time than the
echocardiographic recording.
All complications (implantation failure, device or lead dislodgements, implantation related
infection, death) were also prospectively documented.
Conventional 2D-Echocardiography:
Transthoracic echocardiography was performed using a commercially available ultrasound
machine (VividTM E95, GE Vingmed Ultrasound AS; Epiq, Philips Medical Systems). Baseline and
follow-up echocardiographic examinations were performed using the same machine. Conventional
echocardiographic data were analysed according to the recommendations of the European
Association of Cardiovascular Imaging. Standard parasternal long- and short-axis and apical
four and two-chamber and long axis view were acquired. Left ventricular end-diastolic volume
(LVEDV), end-systolic volume (LVESV) and left ventricular ejection fraction were calculated
using Simpson's rule in a four-chamber view.
The ystolic function of the right ventricle was evaluated by tricuspid annular plane systolic
excursion (TAPSE) in a standard apical four-chamber view. Finally, valve function and
particularly tricuspid function was assessed following the European recommendations.
All echocardiographic values will be obtained from the average of measurements from six
continuous normal cardiac beats.
Ethical considerations:
The investigators followed the declaration of Helsinki regarding human experimentation.
Moreover, the investigators respected national legislation regarding clinical research and
confidentiality of the data obtained in this study. All the participants were informed about
the aims and procedures of the study and signed an informed consent form before the inclusion
in the study. The local ethical committees reviewed and approved this protocol.
