Evaluation of Accelerated Bachmann Bundle Area Pacing in Heart Failure With Reduced ejectIon Fraction Who Have electrocarDioGraphic Evidence of Interatrial Block and Indicated for Implantable Cardioverter Defibrillator

NCT07547306 | Not Yet Recruiting DMC

• 1 other identifier: BRIDGE-HF
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the effect of accelerated atrial resynchronization achieved through Bachmann bundle pacing at the time of implantable cardioverter-defibrillator implantation in patients with heart failure with reduced ejection fraction and interatrial block

Conditions

Heart Failure and Reduced Ejection Fraction

Keywords

heart failure and reduced ejection fraction; Bachmann bundle area pacing; interatrial block

Outcome Measures

Primary Outcomes (1)

• Relative change in NT-proBNP at 6 weeks (accelerated Bachmann bundle area pacing ON) compared with baseline (accelerated Bachmann bundle area pacing OFF).

  up to 6 weeks

Secondary Outcomes (13)

• Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score at 6 weeks, 16 weeks, and 12 months compared with baseline.

  up to 12 months

• Changes in E and A wave velocity (m/s) on echocardiography at 6 weeks, 16 weeks, and 12 months compared with baseline.

  up to 12 months

• Changes in E/A and E/E' ratios on echocardiography at 6 weeks, 16 weeks, and 12 months compared with baseline.

  up to 12 months

• Change in left atrial diameter (mm) on echocardiography at 6 weeks, 16 weeks, and 12 months compared with baseline.

  up to 12 months

• Change in left atrial strain (%) on echocardiography at 6 weeks, 16 weeks, and 12 months compared with baseline

  up to 12 months

Study Arms (3)

BBAP on

EXPERIMENTAL

In the Bachmann bundle pacing ON group, the implantable cardioverter-defibrillator will be programmed for 6 weeks with a lower rate limit (LRL) of 70 beats per minute, DDDR mode, and atrial preference pacing (APP) enabled. After the initial 6-week randomized period, to eliminate the effects of prior pacing, the implantable cardioverter-defibrillator in both groups will be reprogrammed to an LRL of 30 beats per minute in VVI mode, followed by a 4-week washout period. After the washout period, participants will undergo crossover, such that those initially assigned to the Bachmann bundle pacing ON group will be switched to the OFF group, and those initially assigned to the OFF group will be switched to the ON group, with the assigned pacing mode maintained for an additional 6 weeks.

Device: BBAP on

BBAP off

ACTIVE COMPARATOR

In the Bachmann bundle pacing OFF group, the implantable cardioverter-defibrillator will be programmed for 6 weeks with an LRL of 30 beats per minute in VVI mode. After the initial 6-week randomized period, to eliminate the effects of prior pacing, the implantable cardioverter-defibrillator in both groups will be reprogrammed to an LRL of 30 beats per minute in VVI mode, followed by a 4-week washout period. After the washout period, participants will undergo crossover, such that those initially assigned to the Bachmann bundle pacing ON group will be switched to the OFF group, and those initially assigned to the OFF group will be switched to the ON group, with the assigned pacing mode maintained for an additional 6 weeks.

Device: BBAP off

RAAP on

OTHER

A comparator cohort receiving accelerated atrial resynchronization via right atrial appendage pacing will be enrolled separately at institutions distinct from those recruiting participants for Bachmann bundle pacing. In the right atrial appendage pacing cohort, the implantable cardioverter-defibrillator will be programmed for the initial 6 weeks with an LRL of 70 beats per minute, DDDR mode, and atrial preference pacing enabled. Individualized adjustment of the LRL will be permitted at the investigator's discretion based on the patient's clinical status.

Drug: RAAP

Interventions

BBAP on DEVICE

ICD programmed for 6 weeks with LRL 70 beats/min, DDDR, and APP enabled.

BBAP on

BBAP off DEVICE

ICD programmed for 6 weeks with an LRL 30 beats/min in VVI mode

BBAP off

RAAP DRUG

ICD programmed for 6 weeks with LRL 70 beats/min, DDDR, and APP enabled.

RAAP on

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years at the time of screening.
• A documented diagnosis of chronic heart failure with New York Heart Association (NYHA) class II-IV.
• Left ventricular ejection fraction (LVEF) ≤40%, documented by an imaging study performed within 12 months prior to screening.
• Receiving optimized guideline-directed medical therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF), unless contraindicated or not tolerated:
• Participants receiving ongoing treatment must be on a stable regimen for at least 1 month prior to screening (except for diuretics).
• Most patients with heart failure require diuretics for volume control, and dose adjustments may be made based on clinical status, including symptoms, signs, and body weight. Each participant should receive individualized diuretic therapy to maintain optimal volume status.
• Presence of interatrial block (IAB), defined as a P-wave duration ≥120 ms on a 12-lead electrocardiogram or ECG recording device.
• An indication for dual-chamber implantable cardioverter-defibrillator (ICD) implantation for primary or secondary prevention.
• NT-proBNP measured within 3 months prior to randomization meeting one of the following criteria:
• NT-proBNP \>300 pg/mL

You may not qualify if:

• Non-paroxysmal AF.
• Uncontrolled tachyarrhythmia.
• Sinus bradycardia requiring continuous atrial pacing or atrioventricular block requiring ventricular pacing.
• Acute decompensated heart failure at the time of screening or hospitalization for worsening heart failure within 4 weeks prior to enrollment.
• Prior mechanical tricuspid valve replacement.
• Coronary revascularization (PCI or CABG) or valve surgery/repair performed within 12 weeks prior to enrollment, or planned after randomization.
• Obstructive hypertrophic cardiomyopathy.
• Infiltrative cardiomyopathy, including but not limited to amyloidosis, sarcoidosis, or Fabry disease.
• An indication for cardiac resynchronization therapy (CRT).
• Chronic kidney disease, defined as an estimated glomerular filtration rate (eGFR) \<15 mL/min/1.73 m² calculated using the CKD-EPI equation.
• Chronic liver disease, defined as alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase \>3 times the upper limit of normal at screening.
• Severe pulmonary disease, such as cor pulmonale or irreversible lung disease requiring inhaled therapy or long-term oxygen therapy.
• Uncontrolled hypertension, defined as a mean blood pressure \>140/90 mmHg based on outpatient clinic measurements or home blood pressure recordings within the previous 30 days, or ongoing up-titration of antihypertensive medications.
• Pregnant or breastfeeding women, or women planning pregnancy or breastfeeding during the study period.
• Active malignancy requiring treatment at the time of screening.

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Medtronic: collaborator

MeSH Terms

Conditions

Heart Failure, Systolic; Interatrial Block

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases; Heart Block; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eue-Keun Choi, M.D. Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eue-Keun Choi, M.D. Ph.D.

CONTACT

82-2-2072-0688; choiek417@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The primary hypothesis will be evaluated through randomized allocation. For secondary analyses, a comparative assessment of effectiveness and safety versus the commonly used approach of accelerated atrial resynchronization via right atrial appendage pacing is deemed necessary; therefore, patients treated with right atrial appendage pacing will be prospectively enrolled as a separate cohort at institutions distinct from those recruiting for Bachmann bundle pacing

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: April 23, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 23, 2026

Record last verified: 2026-04