The Effect of "Cerclage Pacing" for the Heart Failure Patients Who Need Cardiac Resynchronization Therapy (CRT) (Cerclage-CRT)

Tau-Medical

Status: Completed

Conditions: LBBB Complete; Heart Failure

Treatments: Device: Medtronic 4196 lead

Study type: Interventional

Funder types: Industry

Identifiers

NCT03438591

Cerclage-CRT

Details and patient eligibility

About

trans-coronary sinus intraseptal pacing (cerclage pacing)

Full description

This study is aimed at looking at the effect of "Cerclage pacing" for the heart failure patients who need cardiac resynchronization therapy (CRT). The study hypothesis is that parahisian pacing by 'cerclage pacing' may have a similar benefit as is seen with permanent Hisian pacing

Enrollment: 2 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• who need cardiac resynchronization therapy (CRT) or CRT-non responder
• Left bundle branch block [LBBB]) > 120ms of QRS width
• Ejection fraction (EF) < 35%
• NYHA class III-IV in spite of optimal medical Tx

Exclusion criteria

• Unsuitable coronary vein anatomy on cardiac CT
• Subjects with prosthetic mechanical tricuspid valve
• Active infection
• Life expectancy less than 6 months

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Cerclage-CRT (medtronic 4196 lead)

Experimental group

Description:

trans-coronary sinus intraseptal pacing (cerclage pacing) which technology to position the pacemaker lead into the septum for 'parahisian pacing'

Treatment:

Device: Medtronic 4196 lead