Back to resultsThe Effect of "Cerclage Pacing" for the Heart Failure Patients Who Need Cardiac Resynchronization Therapy (CRT) (Cerclage-CRT)
Primary Purpose
Heart Failure, LBBB Complete
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Medtronic 4196 lead
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring cerclage pacing, cerclage-CRT, wide QRS
Eligibility 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
Sites / Locations
- Pusan National University Yangsan Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cerclage-CRT (medtronic 4196 lead)
Arm Description
trans-coronary sinus intraseptal pacing (cerclage pacing) which technology to position the pacemaker lead into the septum for 'parahisian pacing'
Outcomes
Primary Outcome Measures
rate of procedural success
Narrowing QRS by 20% or greater compared with baseline QRS width
Secondary Outcome Measures
Change in subjects' symptoms referred to NYHA Classification System
NYHA (New York Heart Association) : +1 grade
Change in subjects' improvement of parameters by Echocardiography
Ejection Fraction +5%
Change of Six minute walk Distance
improvement of SMWD
interrogation index of pacemaker lead
interrogation index of pacemaker lead
Full Information
NCT ID
NCT03438591
First Posted
February 13, 2018
Last Updated
September 9, 2019
Sponsor
Tau Pnu Medical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03438591
Brief Title
The Effect of "Cerclage Pacing" for the Heart Failure Patients Who Need Cardiac Resynchronization Therapy (CRT)
Acronym
Cerclage-CRT
Official Title
The Effect of "Cerclage Pacing" for the Heart Failure Patients Who Need Cardiac Resynchronization Therapy (CRT): Early Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
March 5, 2018 (Actual)
Primary Completion Date
March 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tau Pnu Medical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, LBBB Complete
Keywords
cerclage pacing, cerclage-CRT, wide QRS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
patients who meet the criteria of current CRT treatment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cerclage-CRT (medtronic 4196 lead)
Arm Type
Experimental
Arm Description
trans-coronary sinus intraseptal pacing (cerclage pacing) which technology to position the pacemaker lead into the septum for 'parahisian pacing'
Intervention Type
Device
Intervention Name(s)
Medtronic 4196 lead
Intervention Description
Cerclage-CRT pacing with Medtronic 4196 lead (Attain Ability Lead)
Primary Outcome Measure Information:
Title
rate of procedural success
Description
Narrowing QRS by 20% or greater compared with baseline QRS width
Time Frame
immediate postprocedure
Secondary Outcome Measure Information:
Title
Change in subjects' symptoms referred to NYHA Classification System
Description
NYHA (New York Heart Association) : +1 grade
Time Frame
12 months
Title
Change in subjects' improvement of parameters by Echocardiography
Description
Ejection Fraction +5%
Time Frame
12 months
Title
Change of Six minute walk Distance
Description
improvement of SMWD
Time Frame
12 months
Title
interrogation index of pacemaker lead
Description
interrogation index of pacemaker lead
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
June-Hong Kim, MD, PhD
Organizational Affiliation
Pusan National University Yangsan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
State/Province
Gyeongsangnamdo
ZIP/Postal Code
50602
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26654919
Citation
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.
Results Reference
background
Learn more about this trial
The Effect of "Cerclage Pacing" for the Heart Failure Patients Who Need Cardiac Resynchronization Therapy (CRT)
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