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

Heart Failure Clinical Trial

— Cerclage-CRT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03438591
• Other study ID #: Cerclage-CRT
• Status: Completed
• Phase: N/A
• Start date: March 5, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: September 2019
• Source: Tau Pnu Medical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

trans-coronary sinus intraseptal pacing (cerclage pacing)

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: June 30, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• LBBB Complete

Intervention

Device:
• Medtronic 4196 lead
Cerclage-CRT pacing with Medtronic 4196 lead (Attain Ability Lead)

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan	Gyeongsangnamdo

Sponsors (1)

Lead Sponsor	Collaborator
Tau Pnu Medical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of procedural success	Narrowing QRS by 20% or greater compared with baseline QRS width	immediate postprocedure
Secondary	Change in subjects' symptoms referred to NYHA Classification System	NYHA (New York Heart Association) : +1 grade	12 months
Secondary	Change in subjects' improvement of parameters by Echocardiography	Ejection Fraction +5%	12 months
Secondary	Change of Six minute walk Distance	improvement of SMWD	12 months
Secondary	interrogation index of pacemaker lead	interrogation index of pacemaker lead	12 months