AV Delay Optimization vs. Intrinsic Conduction in Pacemaker Patients With Long PR Intervals

NCT02154750 | Completed Results FDA Device

• 1 other identifier: 130663
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, prospective clinical trial to determine the effects of two different pacemaker atrioventricular delay (AV delay) settings on heart function in patients with dual chamber pacemakers implanted for symptomatic bradycardia with long PR intervals (delayed conduction between upper and lower chambers of the heart). The study will compare a long, fixed AV delay (standard) with an optimized AV delay for each individual using echocardiography (experimental).

Conditions

Atrioventricular Block; Sick Sinus Syndrome; Symptomatic Bradycardia; Cardiac Arrhythmia

Keywords

Atrioventricular delay; AV delay; Pacemaker; Sick Sinus Syndrome; Bradycardia; PR interval; Atrioventricular block; AV block; Echocardiography; Arrhythmia; AV optimization

Outcome Measures

Primary Outcomes (8)

• Comparison of Change in Echocardiographic Parameters LV Dimension at End-diastole, LV Dimension at End-systole, and Tricuspid Annular Plane Systolic Excursion (cm) From Baseline to Followup, in Optimized AV Delay Versus Long-fixed AV Delay Groups.

  Comparison (∆) of change in echocardiographic parameters left ventricular (LV) dimension at end-diastole, left ventricular (LV) dimension at end-systole, and tricuspid annular plane systolic excursion (cm) from baseline to followup, in Optimized AV delay versus Long-fixed AV delay groups. A reduction LV dimension indicates improvement in function, and an increase in tricuspid annular plane excursion represents an improvement in function.

  6 months

• Comparison of Echocardiographic Parameters Mitral E Wave Velocity (cm/s) and Mitral A Wave Velocity (cm/s) at Baseline and Followup, in Optimized AV Delay Versus Long-fixed AV Delay Group.

  Comparison (∆) of echocardiographic parameters mitral E wave velocity (cm/s) and mitral A wave velocity (cm/s) at baseline and followup, in Optimized AV delay versus Long-fixed AV delay group. An increase in mitral E wave velocity and a decrease in mitral A velocity represent an improvement in function.

  6 months

• Comparison of Change in Echocardiographic Parameter ΔE/A and Mean E/e' Ratio (Unitless) From Baseline to Followup, in Optimized AV Delay Versus Long-fixed AV Delay Groups.

  Comparison (Δ) of change in echocardiographic parameter ΔE/A and Mean E/e' ratio (unitless) from baseline to followup, in Optimized AV delay versus Long-fixed AV delay groups. An higher delta E/A and mean E/e' ratio represent improvement in function,

  6 months

• Comparison of Echocardiographic Parameter Deceleration Time (Msec) at Baseline and Followup, in Optimized AV Delay Versus Long-fixed AV Delay Group.

  Comparison (∆) of Echocardiographic Parameter Deceleration time (msec) at Baseline and Followup, in Optimized AV Delay Versus Long-fixed AV Delay Group. A reduction in deceleration time represents an improvement in function.

  6 months

• Comparison of Change in Echocardiographic Parameters LVED End Diastolic Volume Index, LVES Volume Index, Maximum LA Volume Index, and Minimum LA Volume Index (ml/m2) From Baseline to Follow-up, in Optimized AV Delay Versus Long-fixed AV Delay Groups.

  Comparison of change in echocardiographic parameters left ventricular end diastolic (LVED) volume index, left ventricular end systolic (LVES) volume index, maximum left atrial (LA) volume index, and minimum left atrial (LA) volume index (ml/m2) from baseline to follow-up, in Optimized AV delay versus Long-fixed AV delay groups. A reduction in volume indexes represents an improvement in function.

  6 months

• Comparison of Change in Echocardiographic Parameters Left Ventricular Ejection Fraction and Global Longitudinal Strain (%) From Baseline to Followup, in Optimized AV Delay Versus Long-fixed AV Delay Groups.

  Comparison (∆) of Change in Echocardiographic Parameters Left Ventricular Ejection Fraction and Global Longitudinal Strain (%) From Baseline to Followup, in Optimized AV Delay Versus Long-fixed AV Delay Groups. An increase in left ventricular ejection time represents an improvement in function. A more negative global longitudinal strain % represents an improvement in function.

  6 months

• Comparison of Change in Echocardiographic Parameters Tricuspid Regurgitation (TR) Velocity m/s From Baseline to Followup, in Optimized AV Delay Versus Long-fixed AV Delay Groups.

  Comparison (∆) of Change in Echocardiographic Parameters Tricuspid Regurgitation (TR) velocity m/s From Baseline to Followup, in Optimized AV Delay Versus Long-fixed AV Delay Groups. An reduction in tricuspid regurgitation velocity represents an improvement in function.

  6 months

• Comparison of Change in Echocardiographic Parameters Left Ventricular Mass (gm) From Baseline to Followup, in Optimized AV Delay Versus Long-fixed AV Delay Groups.

  Comparison (∆) of Change in Echocardiographic Parameters left ventricular mass (gm) From Baseline to Followup, in Optimized AV Delay Versus Long-fixed AV Delay Groups. A reduction in left ventricular mass represents an improvement in function.

  6 months

Secondary Outcomes (1)

• Comparison of Measured Distance Walked in 6 Minutes in Meters From Baseline and Followup, in Optimized AV Delay Group Versus Long-fixed AV Delay Group.

  6 months

Study Arms (2)

Long, fixed AV delay

ACTIVE COMPARATOR

Pacemaker will be set to a long, fixed AV delay to minimize ventricular pacing

Device: Long, fixed AV delay

Short, optimized AV delay

EXPERIMENTAL

Pacemaker will be set to the AV delay that produces the greatest cardiac output in echocardiography for each patient enrolled

Device: Short, optimized AV delay

Interventions

Long, fixed AV delay DEVICE

Pacemaker will be set to a long, fixed AV delay to minimize ventricular pacing

Long, fixed AV delay

Short, optimized AV delay DEVICE

Pacemaker will be set to the AV delay that produces the greatest cardiac output in echocardiography for each patient enrolled.

Short, optimized AV delay

Eligibility Criteria

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

You may qualify if:

• Patients greater than 18 years of age
• Patients with symptomatic sinus bradycardia
• Patients who meet standard indications for dual chamber pacemaker implantation
• Patients who have 1st degree AV block determined by PR interval \> 200ms

You may not qualify if:

• Patients with complete or high grade AV block
• Patients who are unable to complete dual chamber pacemaker implantation for any reason
• Patients with congestive heart failure determined by a Left Ventricular Ejection Fraction \< 45%
• Patients with persistent atrial fibrillation
• Sustained premature ventricular contractions (PVCs), premature atrial contractions (PACs), atrial flutter, or other heart conditions that may interfere with echocardiography measurements
• Patients who are pregnant
• Patients with Paroxysmal Atrial Fibrillation that have had an episode(s) within 30 days of consent

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD Sulpizio Cardiovascular Center

La Jolla, California, 92093, United States

Location

Related Publications (4)

• Sawhney NS, Waggoner AD, Garhwal S, Chawla MK, Osborn J, Faddis MN. Randomized prospective trial of atrioventricular delay programming for cardiac resynchronization therapy. Heart Rhythm. 2004 Nov;1(5):562-7. doi: 10.1016/j.hrthm.2004.07.006.

  PMID: 15851220 BACKGROUND

• Tops LF, Schalij MJ, Bax JJ. The effects of right ventricular apical pacing on ventricular function and dyssynchrony implications for therapy. J Am Coll Cardiol. 2009 Aug 25;54(9):764-76. doi: 10.1016/j.jacc.2009.06.006.

  PMID: 19695453 BACKGROUND

• Iliev II, Yamachika S, Muta K, Hayano M, Ishimatsu T, Nakao K, Komiya N, Hirata T, Ueyama C, Yano K. Preserving normal ventricular activation versus atrioventricular delay optimization during pacing: the role of intrinsic atrioventricular conduction and pacing rate. Pacing Clin Electrophysiol. 2000 Jan;23(1):74-83. doi: 10.1111/j.1540-8159.2000.tb00652.x.

  PMID: 10666756 BACKGROUND

• Sweeney MO, Ellenbogen KA, Tang AS, Whellan D, Mortensen PT, Giraldi F, Sandler DA, Sherfesee L, Sheldon T; Managed Ventricular Pacing Versus VVI 40 Pacing Trial Investigators. Atrial pacing or ventricular backup-only pacing in implantable cardioverter-defibrillator patients. Heart Rhythm. 2010 Nov;7(11):1552-60. doi: 10.1016/j.hrthm.2010.05.038. Epub 2010 Jun 4.

  PMID: 20685401 BACKGROUND

MeSH Terms

Conditions

Atrioventricular Block; Sick Sinus Syndrome; Arrhythmias, Cardiac; Bradycardia

Condition Hierarchy (Ancestors)

Heart Block; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arrhythmia, Sinus

Results Point of Contact

• Title: Gregory Feld, MD
• Organization: UC San Diego Health

gfeld@health.ucsd.edu

(858) 246-2972

Study Officials

• Gregory K Feld, MD

  UCSD Electrophysiology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: May 28, 2014
• First Posted: June 3, 2014
• Study Start: June 1, 2013
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: July 24, 2025
• Results First Posted: June 12, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)