Primary objectives:1. To compare LVESV change between LBBAP and biventricular pacing in patients with AF and LV dysfunction.Secondary objectives: 2. To compare change in quality of life, New York Heart Association functional class, 6-minute walking…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Left ventricular end-systolic volume change compared to baseline.
Secondary outcome
NYHA functional class, Minnesota Living with Heart Failure Questionnaire
(MLHFQ), 6-minute walking distance, ECG (vectorcardiographic QRS area, QRS
duration), echocardiography (LVESV, LVEF, global longitudinal strain),
NT-proBNP, lead and device performance (sensing, pacing, expected battery
life), complications and costs will be evaluated for each pacing mode.
Background summary
Patients with AF and LV dysfunction may require ventricular pacing because of
bradycardia, AV junction ablation, or for cardiac resynchronization therapy
(CRT). RV pacing is associated with the risk of adverse LV remodelling and
heart failure, in particular in those with pre-existing LV dysfunction. Both
LBBAP and biventricular pacing can prevent LV dyssynchrony. It is unknown which
pacing mode best prevents or reverses LV adverse remodelling in patients with
AF who require ventricular pacing or CRT.
Study objective
Primary objectives:
1. To compare LVESV change between LBBAP and biventricular pacing in patients
with AF and LV dysfunction.
Secondary objectives:
2. To compare change in quality of life, New York Heart Association functional
class, 6-minute walking distance, QRS duration, vectorcardiographic QRS area,
LVEF, global longitudinal strain and NT-proBNP between LBBAP and biventricular
pacing in patients with AF and LV dysfunction.
Study design
Randomized patient and assessor blinded non-inferiority cross-over trial.
Intervention
Patients will be randomized according to a crossover design to 6 months of
LBBAP followed by 6 months of biventricular pacing, or vice cersa. Patients
will be followed according to routine clinical practice.
Study burden and risks
For the purpose of this randomized controlled trial, patients will also receive
a LBBAP lead. The additional risk of serious adverse events is ~1.5% (lead
dislodgement 1.1%, 0.4% acute coronary syndrome [all managed conservatively
without further sequelae in prior studies]).(1)
Patients who participate in the trial will also be asked to perform 3
six-minute walking tests and to fill out 3 questionnaires. All other procedures
are performed according to routine clinical practice.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- Adults >=18 years with permanent AF and LVEF < 50% who either require
ventricular pacing because of bradycardia including patients undergoing AV
junction ablation, or have an indication for cardiac resynchronization therapy.
- Expected percentage of ventricular pacing > 40%
- >= 3 months of heart failure medication optimization
Of note, patients who already have a device, but require an upgrade to a
cardiac resynchronization therapy device, can also be included
Exclusion criteria
- Age < 18 years
- Pregnancy or active pregnancy wish
- Not eligible for implantation of an RV lead, LBBAP lead, or LV lead in the
coronary sinus
- The need for a right-sided device implantation
- Recent valve intervention/surgery or acute myocardial infarction (< 6 months)
- NYHA functional class IV heart failure, left ventricular assist device or
cardiac transplant
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL84372.058.23 |