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Cardiac resynchronization therapy versus left bundle branch area pacing in patients with atrioventricular block and mild to moderate heart failure: A prospective multicenter study (BLOCK NAGOYA PACING STUDY)

Cardiac resynchronization therapy versus left bundle branch area pacing for atrioventricular block and heart failure (BLOCK NAGOYA STUDY)

Murohara Toyoaki

Department of Cardiology, Nagoya University Graduate School of Medicine

65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8550, Japan

murohara@med.nagoya-u.ac.jp

Yanagisawa Satoshi

Department of Advanced Cardiovascular Therapeutics, Nagoya University Graduate School of Medicine

65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8550, Japan

81-52-744-2148

yanagisawa-sato@med.nagoya-u.ac.jp

Pending

Nov. 22, 2024

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

treatment purpose

Patients indicated for newly permanent pacemaker implantation due to advanced atrioventricular block (second and third degree).
Patients with complicated heart failure and moderately decreased left ventricular ejection function (35-50%) before implantation.
High frequency of ventricular pacing with >40% after implantation.

Patients indicated for defibrillator lead implantation
Patients who are not required for permanent pacemaker implantation owing to temporal atrioventricular block
Anatomical difficulty of transvenous lead implantation
Upgrading cases from prior pacemaker devices or re-implantation cases
Inability to obtain informed consent from a patient

Both

Atrioventricular block, chronic heart failure

Patients are randomly assigned to therapeutic groups of LBBBAP pacing and CRT pacing. All patients are examined by echocardiography, blood examination test, and electrocardiogram six months after the implantation, and outcomes are compared between the two groups. Adverse events and prognoses are assessed for two years after the implantation.

Atrioventricular block, chronic heart failure

An improvement of LVEF

An improvement of LVEF from before to after 6 months

An improvement of BNP levels from before to after 6 months
An improvement of LVEDV, LVESV, LVDd, and LVDs from before to after 6 months
Pacing QRS duration at 6 months after implantation
Heart failure hospitalization and ventricular arrhythmia events after 2 years
Adverse events after 2 years (lead dislodgement, lead re-implantation, lead fracture, device infection, lead perforation, bleeding, and all-cause death)

+81-52-744-2479

Nov. 17, 2024

Yes

none