Physiologic Pacing for Symptomatic First-Degree Heart Block

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2025-06-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Symptomatic First-degree Heart Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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DDD-50 followed by AAI-DDD 50

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

Group Type OTHER

Dual chamber Medtronic pacemaker implantation.

Intervention Type DEVICE

All patients will undergo a dual chamber Medtronic pacemaker implantation meeting approved indications for pacemaker implantation per Centers for Medicare \& Medicaid Services (CMS) guidelines.

Pacemaker Model: Azure XT W1DR01. Right ventricular lead model: Medtronic 3830.

DDD-50 pacing program

Intervention Type OTHER

This device programming attempts to increase the amount of ventricular pacing via the Medtronic 3830 lead. Since the enrolled patients have a prolonged PR interval, this programming attempts to synchronic atrial and ventricular contractions.

AAI-DDD 50 pacing program

Intervention Type OTHER

This device programming attempts to encourage native conduction and minimize ventricular pacing via the Medtronic 3830 lead. This programming attempts to minimize ventricular pacing, which has been associated with worse outcomes by causing ventricular dyssynchrony between the left and right ventricles.

AAI-DDD 50 followed by DDD-50

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

Group Type OTHER

Dual chamber Medtronic pacemaker implantation.

Intervention Type DEVICE

All patients will undergo a dual chamber Medtronic pacemaker implantation meeting approved indications for pacemaker implantation per Centers for Medicare \& Medicaid Services (CMS) guidelines.

Pacemaker Model: Azure XT W1DR01. Right ventricular lead model: Medtronic 3830.

DDD-50 pacing program

Intervention Type OTHER

This device programming attempts to increase the amount of ventricular pacing via the Medtronic 3830 lead. Since the enrolled patients have a prolonged PR interval, this programming attempts to synchronic atrial and ventricular contractions.

AAI-DDD 50 pacing program

Intervention Type OTHER

This device programming attempts to encourage native conduction and minimize ventricular pacing via the Medtronic 3830 lead. This programming attempts to minimize ventricular pacing, which has been associated with worse outcomes by causing ventricular dyssynchrony between the left and right ventricles.

Interventions

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Dual chamber Medtronic pacemaker implantation.

All patients will undergo a dual chamber Medtronic pacemaker implantation meeting approved indications for pacemaker implantation per Centers for Medicare \& Medicaid Services (CMS) guidelines.

Pacemaker Model: Azure XT W1DR01. Right ventricular lead model: Medtronic 3830.

Intervention Type DEVICE

DDD-50 pacing program

This device programming attempts to increase the amount of ventricular pacing via the Medtronic 3830 lead. Since the enrolled patients have a prolonged PR interval, this programming attempts to synchronic atrial and ventricular contractions.

Intervention Type OTHER

AAI-DDD 50 pacing program

This device programming attempts to encourage native conduction and minimize ventricular pacing via the Medtronic 3830 lead. This programming attempts to minimize ventricular pacing, which has been associated with worse outcomes by causing ventricular dyssynchrony between the left and right ventricles.

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No