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trans-coronary sinus intraseptal pacing (cerclage pacing)
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cerclage-CRT (medtronic 4196 lead) | Experimental | trans-coronary sinus intraseptal pacing (cerclage pacing) which technology to position the pacemaker lead into the septum for 'parahisian pacing' |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medtronic 4196 lead | Device | Cerclage-CRT pacing with Medtronic 4196 lead (Attain Ability Lead) |
|
| Measure | Description | Time Frame |
|---|---|---|
| rate of procedural success | Narrowing QRS by 20% or greater compared with baseline QRS width | immediate postprocedure |
| Measure | Description | Time Frame |
|---|---|---|
| Change in subjects' symptoms referred to NYHA Classification System | NYHA (New York Heart Association) : +1 grade | 12 months |
| Change in subjects' improvement of parameters by Echocardiography | Ejection Fraction +5% |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| June-Hong Kim, MD, PhD | Pusan National University Yangsan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Yangsan Hospital | Yangsan | Gyeongsangnam-do | 50602 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26654919 | Background | 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. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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patients who meet the criteria of current CRT treatment
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| 12 months |
| Change of Six minute walk Distance | improvement of SMWD | 12 months |
| interrogation index of pacemaker lead | interrogation index of pacemaker lead | 12 months |