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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03438591
Recruitment Status : Completed
First Posted : February 19, 2018
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
June-Hong Kim, MD, PhD, Pusan National University Yangsan Hospital

Brief Summary:
trans-coronary sinus intraseptal pacing (cerclage pacing)

Condition or disease Intervention/treatment Phase
Heart Failure LBBB Complete Device: Medtronic 4196 lead Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: patients who meet the criteria of current CRT treatment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of "Cerclage Pacing" for the Heart Failure Patients Who Need Cardiac Resynchronization Therapy (CRT): Early Feasibility Study
Actual Study Start Date : March 5, 2018
Actual Primary Completion Date : March 30, 2019
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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)




Primary Outcome Measures :
  1. rate of procedural success [ Time Frame: immediate postprocedure ]
    Narrowing QRS by 20% or greater compared with baseline QRS width


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438591


Locations
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Korea, Republic of
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnamdo, Korea, Republic of, 50602
Sponsors and Collaborators
Tau Pnu Medical Co., Ltd.
Investigators
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Principal Investigator: June-Hong Kim, MD, PhD Pusan National University Yangsan Hospital
Publications:
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Responsible Party: June-Hong Kim, MD, PhD, Professor, Pusan National University Yangsan Hospital
ClinicalTrials.gov Identifier: NCT03438591    
Other Study ID Numbers: Cerclage-CRT
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by June-Hong Kim, MD, PhD, Pusan National University Yangsan Hospital:
cerclage pacing
cerclage-CRT
wide QRS
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases