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Conduction System Pacing and AV Junction Ablation in Heart Failure With Atrial Fibrillation (SYNC AF-HTx)

ConditionsHeart FailureAtrial FibrillationDefibrillators, Implantable
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorYonsei University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • LBBP + AVJ Ablation with ICD

    Device

    Insertion of an LBBP lead (Medtronic SelectSecure™ 3830) and performing AVJ ablation to ensure heart rate regularization and ventricular synchronization

  • ICD Only

    Device

    Participants receive standard ICD implantation with a minimal ventricular pacing strategy

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: SYNC groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Composite of all-cause mortality, heart failure hospitalization, or urgent heart transplantation

Occurrence of the first event among the composite components

Time frame
Time Frame: Up to 12 months

Secondary outcomes

1

All cause mortality

All cause deaths including cardiovascular and non-cardiovascular deaths.

Time frame
Up to 12 months
2

Cardiovascular mortality

Cardiovascular death

Time frame
Up to 12 months
3

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.

Time frame
Up to 12 months
4

Urgent heart transplantation

Urgent heart transplantation

Time frame
Up to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yonsei University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: