Physiologic Pacing for Symptomatic First-Degree Heart Block

Ascension Health

Status: Enrolling

Conditions: Symptomatic First-degree Heart Block

Treatments: Other: AAI-DDD 50 pacing program; Device: Dual chamber Medtronic pacemaker implantation.; Other: DDD-50 pacing program

Study type: Interventional

Funder types: Industry

Identifiers

NCT06245304

RTN20230009

Details and patient eligibility

About

The purpose of this study is to determine if physiologic pacing will improve symptoms and outcomes in patients with symptomatic first-degree heart block (pr interval ≥250ms).

Full description

The purpose of this study is to determine if physiologic pacing will improve symptoms and outcomes in patients with symptomatic first-degree heart block (pr interval ≥250ms). Patient will undergo a comparative effectiveness study where patients with symptomatic first-degree heart block (pr interval ≥250ms) undergo left bundle pacing (3830 lead) and are randomized to DDD-50 vs Managed Ventricular pacing-50 (MVP-50; AAI-DDD 50) and undergo a crossover at 3 months. This study will compare two standard of care options utilizing Food and Drug Administration (FDA) approved devices. Patients are evaluated at baseline, 3 months, and 6 months in terms of patient symptoms, exercise capacity, arrhythmia burden, and patient activity.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18 or above
• Ventricular Ejection Fraction (EF) > 50%
• New York Heart Association (NYHA) class II-IV
• PR interval ≥250ms
• Narrow QRS duration (≤140ms) or prolonged QRS duration with typical Right Bundle Branch Block (RBBB) morphology on 12 lead ECG and sinus rhythm

Exclusion criteria

• Permanent atrial fibrillation (AF)
• Patients who are unable to perform a 6 minute hall walk
• Other serious medical condition with life expectancy of less than 1 year
• Lack of capacity to consent
• Pregnancy
• Contraindication to use of the relevant study device or leads (as per current manuals from manufacturer)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

DDD-50 followed by AAI-DDD 50

Other group

Description:

Patients will be programmed to DDD-50 first. After 3 months, patients will be programmed to AAI-DDD 50.

Treatment:

Other: AAI-DDD 50 pacing program

Device: Dual chamber Medtronic pacemaker implantation.

Other: DDD-50 pacing program

AAI-DDD 50 followed by DDD-50

Other group

Description:

Patients will be programmed to AAI-DDD-50 first. After 3 months, patients will be programmed to DDD 50.

Treatment:

Other: AAI-DDD 50 pacing program

Device: Dual chamber Medtronic pacemaker implantation.

Other: DDD-50 pacing program