Heart FailureCerclage-CRTNCT03438591
The Effect of "Cerclage Pacing" for the Heart Failure Patients Who Need Cardiac Resynchronization Therapy (CRT)
A study testing Medtronic 4196 lead in people with Heart Failure and LBBB Complete, run by Tau-MEDICAL Co., Ltd. at 1 site in South Korea.
Trial summary
trans-coronary sinus intraseptal pacing (cerclage pacing) Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Heart Failure, LBBB Complete
- What is being tested?
- Medtronic 4196 lead
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Mar 2018to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unsuitable coronary vein anatomy on cardiac CT
- Subjects with prosthetic mechanical tricuspid valve
- Active infection
- Life expectancy less than 6 months
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50602
About this study
Official title: The Effect of "Cerclage Pacing" for the Heart Failure Patients Who Need Cardiac Resynchronization Therapy (CRT): Early Feasibility Study
trans-coronary sinus intraseptal pacing (cerclage pacing)
Read the 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
- Conditions
- Heart Failure, LBBB Complete
- Being tested
- Medtronic 4196 lead
- Keywords
- cerclage pacing, cerclage-CRT, wide QRS
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic 4196 leadDevice
Cerclage-CRT pacing with Medtronic 4196 lead (Attain Ability Lead)
| Study group | Role | What they receive |
|---|---|---|
| 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' Receives: Device: Medtronic 4196 lead |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of procedural success
Narrowing QRS by 20% or greater compared with baseline QRS width
Measured: immediate postprocedure
Secondary outcomes (4)
Change in subjects' symptoms referred to NYHA Classification System
NYHA (New York Heart Association) : +1 grade
Measured: 12 months
Change in subjects' improvement of parameters by Echocardiography
Ejection Fraction +5%
Measured: 12 months
Change of Six minute walk Distance
improvement of SMWD
Measured: 12 months
interrogation index of pacemaker lead
interrogation index of pacemaker lead
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start5 Mar 2018
- Primary completion30 Mar 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- patients who meet the criteria of current CRT treatment
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tau-MEDICAL Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, June-Hong Kim, MD, PhD, Pusan National University Yangsan Hospital
- Investigators
- June-Hong Kim, MD, PhD, Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03438591
- Sponsor's protocol ID
- Cerclage-CRT
- Acronym
- Cerclage-CRT
- Status last verified
- Sep 2019
- First submitted
- 13 Feb 2018
- Last updated
- 11 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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. No abstract available.
PubMed 26654919
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of "Cerclage Pacing" for the Heart Failure Patients Who Need Cardiac Resynchronization Therapy (CRT): Early Feasibility Study
- ClinicalTrials.gov ID
- NCT03438591
- Acronym / sponsor ID
- Cerclage-CRT / Cerclage-CRT
- Conditions
- Heart Failure, LBBB Complete
- Keywords
- cerclage pacing, cerclage-CRT, wide QRS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Tau-MEDICAL Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- patients who meet the criteria of current CRT treatment
| Arm | Type | Receives |
|---|---|---|
| Cerclage-CRT (medtronic 4196 lead) | Experimental | Device: Medtronic 4196 leadtrans-coronary sinus intraseptal pacing (cerclage pacing) which technology to position the pacemaker lead into the septum for 'parahisian pacing' |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Unsuitable coronary vein anatomy on cardiac CT
- Subjects with prosthetic mechanical tricuspid valve
- Active infection
- Life expectancy less than 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medtronic 4196 leadCerclage-CRT pacing with Medtronic 4196 lead (Attain Ability Lead) | Device | Cerclage-CRT (medtronic 4196 lead) |
Primary outcome
rate of procedural success
Time frame: immediate postprocedure
Narrowing QRS by 20% or greater compared with baseline QRS width
4 secondary outcomes
Change in subjects' symptoms referred to NYHA Classification System
Time frame: 12 months
Change in subjects' improvement of parameters by Echocardiography
Time frame: 12 months
Change of Six minute walk Distance
Time frame: 12 months
interrogation index of pacemaker lead
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
- Background: PubMed 26654919Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
June-Hong Kim, MD, PhD principal investigator
Pusan National University Yangsan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic 4196 lead in people with Heart Failure and LBBB Complete, run by Tau-MEDICAL Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of procedural success (time frame: immediate postprocedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03438591, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2019.