Physiologic Pacing for Symptomatic First-Degree Heart Block

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).

Study Overview

• Status: Recruiting
• Conditions: Symptomatic First-degree Heart Block
• Intervention / Treatment: Device: Dual chamber Medtronic pacemaker implantation.; Other: DDD-50 pacing program; Other: AAI-DDD 50 pacing program

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Kaiser, MD; Phone Number: 6153295144; Email: daniel.kaiser@ascension.org
• Study Contact Backup: Name: Tonya Fambrough, RN; Phone Number: 6152223085; Email: tonya.fambrough@ascension.org

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Ascension Saint Thomas Midtown
      • Contact: Daniel Kaiser, MD; Phone Number: 615-329-5144; Email: daniel.kaiser@ascension.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	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.
Other: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life per the Minnesota Living with Heart Failure Questionnaire (MLHFQ)	Determine if pacemaker programming influences quality of life based on Minnesota Living with Heart Failure Questionnaire (MLHFQ)	6 months after pacemaker implantation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise capacity	Determine if pacemaker programming influences exercise capacity (6 minute hall walk, Bruce protocol, or modified Bruce protocol).	6 months after pacemaker implantation.
Atrial fibrillation burden	Determine if pacemaker programming influences overall burden of atrial fibrillation.	6 months after pacemaker implantation.
Patient activity	Determine if pacemaker programming influences patient activity (as measured by device accelerometer).	6 months after pacemaker implantation.

Collaborators and Investigators

• Sponsor: Ascension Health
• Collaborators: Medtronic

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: January 14, 2024
• First Submitted That Met QC Criteria: January 29, 2024
• First Posted (Estimated): February 7, 2024

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Block
• Other Study ID Numbers: RTN20230009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No