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

September 9, 2019 updated by: June-Hong Kim, MD, PhD, Tau Pnu Medical Co., Ltd.

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

trans-coronary sinus intraseptal pacing (cerclage pacing)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeongsangnamdo
      • Yangsan, Gyeongsangnamdo, Korea, Republic of, 50602
        • Pusan National University Yangsan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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'
Device: Medtronic 4196 lead
Cerclage-CRT pacing with Medtronic 4196 lead (Attain Ability Lead)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tau Pnu Medical Co., Ltd.

Investigators

  • Principal Investigator: June-Hong Kim, MD, PhD, Pusan National University Yangsan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2018

Primary Completion (Actual)

March 30, 2019

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

February 13, 2018

First Submitted That Met QC Criteria

February 13, 2018

First Posted (Actual)

February 19, 2018

Study Record Updates

Last Update Posted (Actual)

September 11, 2019

Last Update Submitted That Met QC Criteria

September 9, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cerclage-CRT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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