The primary objective of this study is to compare in a randomized trial the effects of permanent LVSP with RVP in patients with a pacemaker indication because of AV conduction disorders, with respect to a composite of all-cause mortality,…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is a composite of all-cause mortality, hospitalization for
heart failure, and a more than 10% point decrease in left ventricular ejection
fraction (LVEF) leading to a LVEF below 50%, which as a binary combined
endpoint will be determined at one year follow-up.
Secondary outcome
Secondary endpoints are:
- Time to first occurrence of all cause mortality or hospitalization for heart
failure.
- Time to first occurrence of all cause mortality.
- Time to first occurrence of hospitalization for heart failure.
- Time to first occurrence of atrial fibrillation (AF) de novo.
- The echocardiographic changes in LVEF at one year.
- The echocardiographic changes in diastolic (dys-)function at one year.
- The occurrence of pacemaker related complications.
- Quality of life (QOL), cost-effectiveness analyses (CEA) and budget impact
analysis (BIA).
The secondary endpoints (other than echocardiographic LVEF change) will be
determined at the end of the follow-up period, when the last included patient
has reached one year follow-up. The individual follow-up time for patients at
this time point will vary with a minimum of one year.
Background summary
Permanent cardiac pacing is the only available therapy in patients with
atrioventricular (AV) conduction disorders and can be life-saving. Right
ventricular pacing (RVP), the routine clinical practice for decades in these
patients, is non-physiologic, leads to dyssynchronous electrical and mechanical
activation of the ventricles, and may cause pacing-induced heart failure and
cardiomyopathy.
Left ventricular septal pacing (LVSP) is an emerging form of physiologic pacing
that can possibly overcome the adverse effects of RVP.
Study objective
The primary objective of this study is to compare in a randomized trial the
effects of permanent LVSP with RVP in patients with a pacemaker indication
because of AV conduction disorders, with respect to a composite of all-cause
mortality, hospitalization for heart failure, and a more than 10% point
decrease in left ventricular ejection fraction (LVEF) leading to a LVEF below
50%. LVSP is anticipated to result in improved outcomes.
Pacemaker related complications are expected to be equal between groups.
Secondary objectives are to evaluate whether LVSP is cost-effective and
associated with an improved quality of life (QOL) as compared to RVP. Quality
of life is expected to improve with LVSP and reduced healthcare resource
utilizations are expected to ensure lower costs in the LVSP group during
follow-up, despite initial higher costs of the implantation.
Study design
The LEAP trial is a multi-center investigator-initiated, prospective,
randomized controlled, open label, blinded endpoint evaluation (PROBE) study.
Intervention
LVSP vs. RVP.
Study burden and risks
LVSP is expected to be as safe as conventional RVP and procedure or lead
related risks for the study subjects are expected to be comparable for both
intervention groups. However, since LVSP is a relatively new implantation
technique in which most implanting physicians need to get more routine, proper
lead positioning may initially take longer: we estimate a mean procedure time
prolongation with LVSP of around 20 minutes.
On the other hand, LVSP might be associated with better outcomes as compared to
RVP, in terms of a reduction in the occurrence of pacing induced heart failure,
as we hypothesize.
Besides baseline and follow-up examinations that are part of routine clinical
care, all participants will undergo a baseline and 12 months follow-up
study-related echocardiography, which contains no extra risk. Additionally,
participants will be asked to fill in questionnaires (QOL, CEA, BIA) at
baseline and every six months follow-up.
universiteitssingel 50
Maastricht 6229 ER
NL
universiteitssingel 50
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria:
- Age >=18 years with a life expectancy with good functional status of at least
1 year.
- Class I or class IIa permanent pacing indication owing to an AV conduction
disorder with an expected ventricular pacing percentage of >= 20%. AV conduction
disorders include:
- acquired third- or second-degree AV block.
- atrial arrhythmia with slow ventricular conduction.
- LVEF >= 40%.
- Signed and dated informed consent form prior to admission to the trial.
Exclusion criteria
Exclusion criteria:
- Heart failure NYHA class III-IV
- Class I indication for cardiac resynchronization therapy
- Class I indication for implantable cardioverter defibrillator
- Previous receipt of a cardiac implantable electronic device (except for
implantable loop recorders)
- Atrial arrhythmia with planned AV junction ablation
- Unstable angina or acute myocardial infarction
- Percutaneous or surgical coronary intervention within 30 days before
enrollment
- Valvular disease with an indication for valve repair or replacement
- Hypertrophic cardiomyopathy with septal wall diameter > 2 cm
- Renal insufficiency requiring hemodialysis
- Active infectious disease or malignancy
- Women who are pregnant
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 |
|---|---|
| ClinicalTrials.gov | NCT04595487 |
| CCMO | NL72047.068.20 |