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Physiologic Pacing for Symptomatic First-Degree Heart Block

NCT06245304 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-02-07

No results posted yet for this study

Summary

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).

Conditions

  • Symptomatic First-degree Heart Block

Interventions

DEVICE

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.

OTHER

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.

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.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Ascension Health

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2024-12-31
Completion
2025-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06245304 on ClinicalTrials.gov