The study will investigate the feasibility of using direct left bundle branch pacing (LBB pacing) as an alternative to biventricular pacing in patients with symptomatic heart failure and an ECG with a typical left bundle branch block pattern. The…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Success rate for implantation of LBB electrode.
Secondary outcome
Secondary endpoints (LBB pacing versus biventricular pacing - calculated both
as intention-to-treat and per-protocol):
- Echocardiographic response after 6 months defined as decrease in left
ventricular systolic diameter of >= 15% of baseline
- Echocardiographic response assessed by chamber dimensions and LVEF on a
continuous scale
- Symptomatic response after 6 months defined as a fall in NYHA class of >= 1
- Improvement in well-being after 6 months defined as a decrease in Minnesota
Living With Heart Failure score of >= 15% of baseline.
- Shortening the duration of the QRS complex defined as the widest paced QRS
complex rated at 12-lead ECG after 6 months.
- Decline in NT-pro BNP value.
- Device-related complications:
*Periprocedural: CS/LBB electrode reoperation, pneumothorax,
hemothorax, pericardial bleeding/tamponade.
*One month postoperative: CS/LBB electrode reoperation, phrenic
nerve stimulation, infection requiring extraction.
Background summary
Biventricular pacing has for more than a decade been standard of care for
patients with low ejection fraction (<35%), symptomatic heart failure despite
optimal medical treatment and an ECG with left bundle branch block (LBBB).
However, it is not always feasible because of several drawbacks such as phrenic
nerve capture or inability to reach the target LV-lead location due to
suboptimal anatomy of the venous coronary system. Physiologic pacing by
directly capturing the left bundle and providing synchronous electrical
activation of the left ventricle can overcome the aforementioned drawbacks of
the conventional treatment.
In the present study we randomize patients to either conventional CRT or LBB
pacing in a 1:1 open, non-blinded design. In the LBB pacing arm, direct LBB
pacing is attempted but if it*s not possible due to technical difficulties, we
will switch to conventional LV-lead placement.
Study objective
The study will investigate the feasibility of using direct left bundle branch
pacing (LBB pacing) as an alternative to biventricular pacing in patients with
symptomatic heart failure and an ECG with a typical left bundle branch block
pattern. The primary endpoint of the study is the success rate of electrode
implantation for direct LBB pacing in a patient group with disease in the
cardiac conduction system as a major contributor to heart failure. If the study
shows that LBB pacing is a possible alternative to biventricular pacing, it may
pave the way for a larger national study.
Study design
The study is an open, single-center study. A total of 50 patients are expected
to be randomized to 1:1 for conventional biventricular pacing (25 participants)
or LBB-pacing (25 participants) and followed for 6 months.
Intervention
Implantation of LBB electrode.
Study burden and risks
Preoperative examinations and follow-up for both groups are similar. The
biggest possible drawback for patients will be a longer implantation time if it
is not possible to place the LBB pacing lead where we have to switch to the
conventional procedure. Procedure time may take approximately 30 minutes longer
if LBB-lead placement is not successful and a switch to the conventional
treatment is necessary.
Michelangelolaan 2
Eindhoven 5623EJ
NL
Michelangelolaan 2
Eindhoven 5623EJ
NL
Listed location countries
Age
Inclusion criteria
-Age 18+
-Ischemic or non-ischemic cardiomyopathy with LVEF <= 35% assessed by
echocardiography,
-NYHA class II-IV heart failure symptoms despite optimal medical treatment
-Either planned new implantation of a biventricular pacing system (CRT-P or
CRT-D), where ECG is with sinus rhythm and a typical left bundle branch block
-Or planned upgrade of existing biventricular pacing system (CRT-P or CRT-D)
pacing system, where ECG is with sinus rhythm and typical left bundle branch
block or there has been> 90% right ventricular pacing from an existing
pacemaker
Exclusion criteria
- Existing biventricular pacing system
- Permanent atrial fibrillation
- AMI or CABG within the last three months
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 | NL74343.100.20 |