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
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