The Effect of "Cerclage Pacing" for the Heart Failure Patients Who Need Cardiac Resynchronization Therapy (CRT)
Cerclage-CRT
1 other identifier
interventional
2
1 country
1
Brief Summary
trans-coronary sinus intraseptal pacing (cerclage pacing)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable heart-failure
Started Mar 2018
Shorter than P25 for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2018
CompletedFirst Posted
Study publicly available on registry
February 19, 2018
CompletedStudy Start
First participant enrolled
March 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2019
CompletedSeptember 11, 2019
September 1, 2019
1.1 years
February 13, 2018
September 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
rate of procedural success
Narrowing QRS by 20% or greater compared with baseline QRS width
immediate postprocedure
Secondary Outcomes (4)
Change in subjects' symptoms referred to NYHA Classification System
12 months
Change in subjects' improvement of parameters by Echocardiography
12 months
Change of Six minute walk Distance
12 months
interrogation index of pacemaker lead
12 months
Study Arms (1)
Cerclage-CRT (medtronic 4196 lead)
EXPERIMENTALtrans-coronary sinus intraseptal pacing (cerclage pacing) which technology to position the pacemaker lead into the septum for 'parahisian pacing'
Interventions
Cerclage-CRT pacing with Medtronic 4196 lead (Attain Ability Lead)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Unsuitable coronary vein anatomy on cardiac CT
- Subjects with prosthetic mechanical tricuspid valve
- Active infection
- Life expectancy less than 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50602, South Korea
Related Publications (1)
Kim JH, Hwang KW, Chon MK, Nam GB. Trans-coronary sinus intraseptal para-Hisian pacing: Cerclage pacing. Heart Rhythm. 2016 Apr;13(4):992-6. doi: 10.1016/j.hrthm.2015.12.002. Epub 2015 Dec 3. No abstract available.
PMID: 26654919BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
June-Hong Kim, MD, PhD
Pusan National University Yangsan Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 13, 2018
First Posted
February 19, 2018
Study Start
March 5, 2018
Primary Completion
March 30, 2019
Study Completion
June 30, 2019
Last Updated
September 11, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share