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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-05

Study Completion Date

2019-06-30

Brief Summary

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trans-coronary sinus intraseptal pacing (cerclage pacing)

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Detailed Description

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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

Conditions

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Heart Failure LBBB Complete

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

patients who meet the criteria of current CRT treatment

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cerclage-CRT (medtronic 4196 lead)

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

Group Type EXPERIMENTAL

Medtronic 4196 lead

Intervention Type DEVICE

Cerclage-CRT pacing with Medtronic 4196 lead (Attain Ability Lead)

Interventions

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Medtronic 4196 lead

Cerclage-CRT pacing with Medtronic 4196 lead (Attain Ability Lead)

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No