Heart FailureNCT07332871
Conduction System Pacing and AV Junction Ablation in Heart Failure With Atrial Fibrillation (SYNC AF-HTx)
A study testing LBBP + AVJ Ablation with ICD and ICD Only in people with Heart Failure and Atrial Fibrillation, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of conduction system pacing (CSP) using left bundle branch pacing (LBBP) and atrioventricular junction (AVJ) ablation in patients with end-stage heart failure and permanent atrial fibrillation (AF). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Heart Failure, Atrial Fibrillation, Defibrillators, Implantable
- What is being tested?
- LBBP + AVJ Ablation with ICD and ICD Only
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2026to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidates for ICD implantation (primary or secondary prevention). Permanent AF (>6 months) unsuitable for or failed catheter ablation. End-stage heart failure considering heart transplant or LVAD. LVEF ≤ 35 within 6 weeks before enrollment. NYHA functional class ≥ II. On GDMT for at least 3 months. Age ≥ 19 years.
Who cannot join
- Existing LVAD or prior heart transplantation. Indications for cardiac resynchronization therapy (CRT). History of mechanical tricuspid valve replacement. Expected survival≤ 12 months. Inability to comply with the study protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Division of Cardiology, Yonsei University College of Medicine.
Seoul
tae hoon kim, MD, PhD, 82-2-2228-8467, thkimcardio@yuhs.ac
About this study
Official title: Safety and efficacY of conductioN System paCing and Atrioventricular Junctional Ablation Combined With ICD Implantation in Patients With End-stage Heart Failure and Atrial Fibrillation Eligible for Heart Transplantation (SYNC AF-HTx) : Multicenter Prospective Randomized Controlled Trial
The purpose of this study is to evaluate the safety and efficacy of conduction system pacing (CSP) using left bundle branch pacing (LBBP) and atrioventricular junction (AVJ) ablation in patients with end-stage heart failure and permanent atrial fibrillation (AF). Participants who are candidates for heart transplantation or left ventricular assist device (LVAD) implantation will be randomized to either the SYNC group (ICD implantation combined with LBBP and AVJ ablation) or the control group (ICD implantation only). The investigators will compare clinical outcomes, including mortality and heart failure hospitalization, between the two strategies over a 1-year follow-up period.
Read the detailed description
End-stage heart failure patients often face a poor prognosis due to comorbid permanent AF, which leads to irregular heart rates and worsens ventricular function. While implantable cardioverter-defibrillators (ICDs) are standard for preventing sudden cardiac death, they may not sufficiently prevent heart failure progression in patients with narrow QRS complexes. This study explores a "SYNC" strategy using LBBP and AVJ ablation to achieve ventricular synchronization and heart rate regularization. This is a multicenter, prospective, randomized (1:1), single-blind trial involving 120 participants.
Inclusion Criteria: Participants must have LVEF≤35%, permanent AF for >6 months, and be eligible for ICD implantation while awaiting heart transplantation or LVAD.
Intervention (SYNC Group): Participants receive an ICD with an LBBP lead (Medtronic SelectSecure™ 3830) and undergo AVJ ablation.
Control Group: Participants receive standard ICD implantation with a minimal ventricular pacing setting.
Follow-up: Clinical assessments, echocardiography, and device profiles will be monitored at baseline, 1, 3, 6, and 12 months post-procedure.
- Being tested
- LBBP + AVJ Ablation with ICD, ICD Only
- Keywords
- Left Bundle Branch Pacing (LBBP), Conduction System Pacing (CSP), Atrioventricular Junction Ablation (AVJ ablation), End-stage Heart Failure, Heart Transplantation, ICD
- Medical subject headings
- Heart Failure, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LBBP + AVJ Ablation with ICDDevice
Insertion of an LBBP lead (Medtronic SelectSecure™ 3830) and performing AVJ ablation to ensure heart rate regularization and ventricular synchronization
ICD OnlyDevice
Participants receive standard ICD implantation with a minimal ventricular pacing strategy
| Study group | Role | What they receive |
|---|---|---|
| SYNC group | Experimental | Combined procedure of ICD implantation, LBBP lead insertion, and AVJ ablation. Receives: Device: LBBP + AVJ Ablation with ICD |
| Control group | Active comparator | Standard ICD implantation with minimal ventricular pacing strategy. Receives: Device: ICD Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of all-cause mortality, heart failure hospitalization, or urgent heart transplantation
Occurrence of the first event among the composite components
Measured: Time Frame: Up to 12 months
Secondary outcomes (5)
All cause mortality
All cause deaths including cardiovascular and non-cardiovascular deaths.
Measured: Up to 12 months
Cardiovascular mortality
Cardiovascular death
Measured: Up to 12 months
Heart failure hospitalization
An unplanned outpatient or emergency department visit or inpatient hospitalization in which the patient presented with signs and symptoms consistent with heart failure and required intravenous therapy.
Measured: Up to 12 months
Urgent heart transplantation
Urgent heart transplantation
Measured: Up to 12 months
LV systolic function
LVEF measure by echocardiography
Measured: 6months and 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07332871
- Sponsor's protocol ID
- 4-2025-1357
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and efficacY of conductioN System paCing and Atrioventricular Junctional Ablation Combined With ICD Implantation in Patients With End-stage Heart Failure and Atrial Fibrillation Eligible for Heart Transplantation (SYNC AF-HTx) : Multicenter Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07332871
- Acronym / sponsor ID
- 4-2025-1357
- Keywords
- Left Bundle Branch Pacing (LBBP), Conduction System Pacing (CSP), Atrioventricular Junction Ablation (AVJ ablation), End-stage Heart Failure, Heart Transplantation, ICD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 12 Jan 2026 (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.
The purpose of this study is to evaluate the safety and efficacy of conduction system pacing (CSP) using left bundle branch pacing (LBBP) and atrioventricular junction (AVJ) ablation in patients with end-stage heart failure and permanent atrial fibrillation (AF). Participants who are candidates for heart transplantation or left ventricular assist device (LVAD) implantation will be randomized to either the SYNC group (ICD implantation combined with LBBP and AVJ ablation) or the control group (ICD implantation only). The investigators will compare clinical outcomes, including mortality and heart failure hospitalization, between the two strategies over a 1-year follow-up period.
Detailed description
End-stage heart failure patients often face a poor prognosis due to comorbid permanent AF, which leads to irregular heart rates and worsens ventricular function. While implantable cardioverter-defibrillators (ICDs) are standard for preventing sudden cardiac death, they may not sufficiently prevent heart failure progression in patients with narrow QRS complexes. This study explores a "SYNC" strategy using LBBP and AVJ ablation to achieve ventricular synchronization and heart rate regularization. This is a multicenter, prospective, randomized (1:1), single-blind trial involving 120 participants.
Inclusion Criteria: Participants must have LVEF≤35%, permanent AF for >6 months, and be eligible for ICD implantation while awaiting heart transplantation or LVAD.
Intervention (SYNC Group): Participants receive an ICD with an LBBP lead (Medtronic SelectSecure™ 3830) and undergo AVJ ablation.
Control Group: Participants receive standard ICD implantation with a minimal ventricular pacing setting.
Follow-up: Clinical assessments, echocardiography, and device profiles will be monitored at baseline, 1, 3, 6, and 12 months post-procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SYNC group | Experimental | Device: LBBP + AVJ Ablation with ICDCombined procedure of ICD implantation, LBBP lead insertion, and AVJ ablation. |
| Control group | Active comparator | Device: ICD OnlyStandard ICD implantation with minimal ventricular pacing strategy. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Candidates for ICD implantation (primary or secondary prevention). Permanent AF (>6 months) unsuitable for or failed catheter ablation. End-stage heart failure considering heart transplant or LVAD. LVEF ≤ 35 within 6 weeks before enrollment. NYHA functional class ≥ II. On GDMT for at least 3 months. Age ≥ 19 years.
Key exclusion criteria (1 listed)
- Existing LVAD or prior heart transplantation. Indications for cardiac resynchronization therapy (CRT). History of mechanical tricuspid valve replacement. Expected survival≤ 12 months. Inability to comply with the study protocol.
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 |
|---|---|---|
| LBBP + AVJ Ablation with ICDInsertion of an LBBP lead (Medtronic SelectSecure™ 3830) and performing AVJ ablation to ensure heart rate regularization and ventricular synchronization | Device | SYNC group |
| ICD OnlyParticipants receive standard ICD implantation with a minimal ventricular pacing strategy | Device | Control group |
Primary outcome
Composite of all-cause mortality, heart failure hospitalization, or urgent heart transplantation
Time frame: Time Frame: Up to 12 months
Occurrence of the first event among the composite components
5 secondary outcomes
All cause mortality
Time frame: Up to 12 months
Cardiovascular mortality
Time frame: Up to 12 months
Heart failure hospitalization
Time frame: Up to 12 months
Urgent heart transplantation
Time frame: Up to 12 months
LV systolic function
Time frame: 6months and 12months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LBBP + AVJ Ablation with ICD and ICD Only in people with Heart Failure and Atrial Fibrillation, run by Yonsei University 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 12 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact tae hoon kim, MD, PhD. (82-2-2228-8467., thkimcardio@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of all-cause mortality, heart failure hospitalization, or urgent heart transplantation (time frame: Time Frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2026.