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

• Sponsor: Tau Pnu Medical Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03438591
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arm: 1
• Actual Duration (Months): 15.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

trans-coronary sinus intraseptal pacing (cerclage pacing)

Condition or Disease	Intervention/Treatment	Phase
Heart Failure; LBBB Complete	Device: Medtronic 4196 lead	N/A

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: patients who meet the criteria of current CRT treatmentpatients 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: Mar 5, 2018
• Actual Primary Completion Date: Mar 30, 2019
• Actual Study Completion Date: Jun 30, 2019

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. rate of procedural success [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 [12 months]

   NYHA (New York Heart Association) : +1 grade

2. Change in subjects' improvement of parameters by Echocardiography [12 months]

   Ejection Fraction +5%

3. Change of Six minute walk Distance [12 months]

   improvement of SMWD

4. interrogation index of pacemaker lead [12 months]

   interrogation index of pacemaker lead

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pusan National University Yangsan Hospital	Yangsan	Gyeongsangnamdo	Korea, Republic of	50602

Sponsors and Collaborators

• Tau Pnu Medical Co., Ltd.

Investigators

• Principal Investigator: June-Hong Kim, MD, PhD, Pusan National University Yangsan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• 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: Feb 19, 2018
• Last Update Posted: Sep 11, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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, Professor, Pusan National University Yangsan Hospital: cerclage pacing; cerclage-CRT; wide QRS
• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of Sep 11, 2019