Health TrialsbyHealthPanel

Conventional Versus Left Bundle Branch Pacing in TAVI

ConditionsAortic Valve StenosisHeart FailurePacemaker-Induced CardiomyopathyTranscatheter Aortic Valve Implantation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Medical Centre Ljubljana

About this trial

This randomized study compares the effects of conventional (right ventricular pacing in patients with LVEF ≥ 40% and cardiac resynchronization therapy in patients with LVEF \< 40 %) versus left bundle branch pacing on left ventricular remodelling in patients with reduced left ventricular ejection fraction (\< 50 %) that need permanent pacemaker implantation after transcatheter aortic valve implantation (TAVI).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Indication for permanent pacemaker implantation after transcatheter aortic valve implantation (during the same hospitalization)

Left ventricular ejection fraction < 50 %.

Disqualifiers

Unsuccessful TAVI procedure with life expectancy < 1 year

Ischemic cardiomyopathy with interventricular septal fibrosis (at least echocardiographic signs of fibrosis)

Severe kidney failure (glomerular filtration rate < 30 ml/min)

Previous permanent pacemaker

Trial design

Design model

Parallel

Treatments tested in this trial

  • Left bundle branch pacemaker

    Device

    Left bundle branch pacing (LBBP) will be the pacing technique. In brief, after localizing the His bundle area the LBBP lead will be positioned approximately 1-1.5 cm distal to the His bundle position in the right ventricular septum. Before screwing the lead deep into the interventricular septum, the suitable position will be confirmed by fluoroscopic signs and adequate paced QSR morphology. Final lead position will be confirmed according to ECG parameters. Given that the pacing parameters with LBBP are typically low and stable, backup RV lead will not be mandatory.

  • Conventional pacing

    Device

    Right ventricular pacing in patients with LVEF ≥ 40% and cardiac resynchronization therapy in patients with LVEF \< 40 %

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Conventional pacingActive comparator 1 intervention
Group B: LBB pacingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Left ventricular ejection fraction

Time frame
12 months

Secondary outcomes

1

Left ventricular systolic diameter

Time frame
12 months
2

Left ventricular diastolic diameter

Time frame
12 months
3

Global work index

Amount of myocardial work performed by the left ventricle during systole.

Time frame
12 months
4

Global constructive work

Positive work performed in systole + negative work performed in isovolumetric relaxation

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Medical Centre Ljubljana

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: