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Completed

NCT Number: NCT03438591

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

trans-coronary sinus intraseptal pacing (cerclage pacing)

Completed

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases LBBB Complete

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50602, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medtronic 4196 lead

Device

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

Primary outcomes

  1. rate of procedural success

    Time frame: immediate postprocedure

    Narrowing QRS by 20% or greater compared with baseline QRS width

Secondary outcomes

  1. Change in subjects' symptoms referred to NYHA Classification System

    Time frame: 12 months

    NYHA (New York Heart Association) : +1 grade

  2. Change in subjects' improvement of parameters by Echocardiography

    Time frame: 12 months

    Ejection Fraction +5%

  3. Change of Six minute walk Distance

    Time frame: 12 months

    improvement of SMWD

  4. interrogation index of pacemaker lead

    Time frame: 12 months

    interrogation index of pacemaker lead

Sponsors and collaborators

Lead sponsor

Tau-MEDICAL Co., Ltd.

Industry

Registry information

Official study title

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

Acronym: Cerclage-CRT

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 19, 2018
Registry last updated
Sep 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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