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

The Effect of Cerclage Pacing for the Heart Failure Patients Who Need Cardiac Resynchronization Therapy (CRT): Early Feasibility Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03438591

Acronym

Cerclage-CRT

Enrollment

Registered

2018-02-19

Start date

2018-03-05

Completion date

2019-06-30

Last updated

2019-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, LBBB Complete

Keywords

cerclage pacing, cerclage-CRT, wide QRS

Brief summary

trans-coronary sinus intraseptal pacing (cerclage pacing)

Detailed 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

Interventions

DEVICEMedtronic 4196 lead

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

patients who meet the criteria of current CRT treatment

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
rate of procedural success	immediate postprocedure	Narrowing QRS by 20% or greater compared with baseline QRS width

Secondary

Measure	Time frame	Description
Change in subjects' symptoms referred to NYHA Classification System	12 months	NYHA (New York Heart Association) : +1 grade
Change in subjects' improvement of parameters by Echocardiography	12 months	Ejection Fraction +5%
Change of Six minute walk Distance	12 months	improvement of SMWD
interrogation index of pacemaker lead	12 months	interrogation index of pacemaker lead

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026