Physiologic Pacing for Symptomatic First-Degree Heart Block

NCT06245304 | Unknown FDA Device

• 1 other identifier: RTN20230009
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Exercise capacity

  6 months after pacemaker implantation.

• Atrial fibrillation burden

  6 months after pacemaker implantation.

• Patient activity

  6 months after pacemaker implantation.

Study Arms (2)

DDD-50 followed by AAI-DDD 50

OTHER

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.; Other: DDD-50 pacing program; Other: AAI-DDD 50 pacing program

AAI-DDD 50 followed by DDD-50

OTHER

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.; Other: DDD-50 pacing program; Other: AAI-DDD 50 pacing program

Interventions

Dual chamber Medtronic pacemaker implantation. 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.

AAI-DDD 50 followed by DDD-50; DDD-50 followed by AAI-DDD 50

DDD-50 pacing program 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 followed by DDD-50; DDD-50 followed by AAI-DDD 50

AAI-DDD 50 pacing program 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; DDD-50 followed by AAI-DDD 50

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ascension Health: lead
• Medtronic: collaborator

Study Sites (1)

Ascension Saint Thomas Midtown

Nashville, Tennessee, 37203, United States

RECRUITING

Central Study Contacts

Daniel Kaiser, MD

CONTACT

6153295144; daniel.kaiser@ascension.org

Tonya Fambrough, RN

CONTACT

6152223085; tonya.fambrough@ascension.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 14, 2024
• First Posted: February 7, 2024
• Study Start: October 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: February 7, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)