Recruiting

Physiologic Pacing

Sponsor:

Ascension Health

Code:

NCT06245304

Conditions

Symptomatic First-degree Heart Block

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dual chamber Medtronic pacemaker implantation.

DDD-50 pacing program

AAI-DDD 50 pacing program

Study Details

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

Study ID

NCT06245304

Start date

Oct 1, 2023

Status verified date

Jan, 2024

Completion date

Jun 30, 2025

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

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.

Primary outcome measure

  • Quality of Life per the Minnesota Living with Heart Failure Questionnaire (MLHFQ) [ Time Frame: 6 months after pacemaker implantation. ]

Central Contacts and Locations

Central contacts

Daniel Kaiser, MD

6153295144daniel.kaiser@ascension.org

Tonya Fambrough, RN

6152223085tonya.fambrough@ascension.org

Locations

Ascension Saint Thomas Midtown

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Daniel Kaiser, MD

615-329-5144daniel.kaiser@ascension.org

More Information

Sponsor

Ascension Health

Last update posted

Feb 7, 2024

Last verified

Jan, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ascension Health on 2024-02-07.