AV Delay Optimization vs. Intrinsic Conduction in Pacemaker Patients With Long PR Intervals (AV Delay)
Primary Purpose
Atrioventricular Block, Sick Sinus Syndrome, Symptomatic Bradycardia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Long, fixed AV delay
Short, optimized AV delay
Sponsored by
About this trial
This is an interventional treatment trial for Atrioventricular Block focused on measuring Atrioventricular delay, AV delay, Pacemaker, Sick Sinus Syndrome, Bradycardia, PR interval, Atrioventricular block, AV block, Echocardiography, Arrhythmia, AV optimization
Eligibility Criteria
Patient population: Individuals with 1st degree atrioventricular (AV) block who have received a dual chamber pacemaker for symptomatic bradycardia.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- UCSD Sulpizio Cardiovascular Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Long, fixed AV delay
Short, optimized AV delay
Arm Description
Pacemaker will be set to a long, fixed AV delay to minimize ventricular pacing
Pacemaker will be set to the AV delay that produces the greatest cardiac output in echocardiography for each patient enrolled
Outcomes
Primary Outcome Measures
Change in cardiac output determined by echocardiography
Secondary Outcome Measures
Changes in functional status determined by 6 minute walk.
Measure distance walked in 6 minutes in meters.
Changes in sense of well being as determined by Short Form - 36 Medical Outcomes Study Questionnaire
Sense of well being score determined by answers to questions on Short Form - 36 questionnaire.
Full Information
NCT ID
NCT02154750
First Posted
May 28, 2014
Last Updated
May 20, 2022
Sponsor
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT02154750
Brief Title
AV Delay Optimization vs. Intrinsic Conduction in Pacemaker Patients With Long PR Intervals
Acronym
AV Delay
Official Title
Evaluation of AV Delay Optimization vs. Intrinsic Conduction in Patients With Long PR Intervals Receiving Dual Chamber Pacemakers for Symptomatic Bradycardia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2013 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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).
Detailed Description
Cardiac pacing is the only effective treatment for symptomatic sinus node dysfunction. Most patients with preserved left ventricular function receive dual chamber pacemakers; however, right ventricular pacing can have detrimental effects on left ventricular function due to the abnormal electrical and mechanical activation pattern of the ventricles.
Many patients receiving dual chamber pacemakers for symptomatic bradycardia have prolonged intrinsic AV conduction (first degree AV block), and as a result, will receive a significant amount of ventricular pacing if programmed at physiologic AV intervals. As an alternative, many pacemakers can be programmed to minimize ventricular pacing at the expense of allowing longer AV delays. However, these long AV delays may not be physiologic and may also lead to reduced cardiac output. At present the standard of care is either to program the pacemaker at an physiologic "natural" AV delay of about 160 msec or to program the pacemaker with a long AV delay to minimize ventricular pacing.
The main scientific questions being addressed in this study are to evaluate the acute and chronic effects on cardiac output, functional status, sense of well-being, and cardiac remodeling of a long AV delay allowing for intrinsic conduction as compared to an echocardiographically optimized AV delay during dual chamber pacing.
Patients enrolled in the trial will complete a run-in period of two weeks prior to randomization in which pacemakers will be programmed with a long-fixed AV delay to allow intrinsic conduction and minimize ventricular pacing (standard). At two weeks, patients will receive a baseline echocardiogram. To determine optimal AV delay, all patients will undergo echocardiographic analysis at varying AV delays. Optimal AV delay will be defined as the AV delay associated with the largest average aortic Doppler velocity time integral (VTI). Then, patients will be randomized to either the short, optimized (experimental) or long, fixed (standard) AV delay groups. To assess functional status and sense of well-being, patients will complete a six minute walk test and Short Form-36 Medical Outcomes Study Questionnaire. Patients return to clinic for another study visit at 6 months and repeat research procedures, including baseline echocardiogram, questionnaire, and 6 minute walk test.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Long, fixed AV delay
Arm Type
Active Comparator
Arm Description
Pacemaker will be set to a long, fixed AV delay to minimize ventricular pacing
Arm Title
Short, optimized AV delay
Arm Type
Experimental
Arm Description
Pacemaker will be set to the AV delay that produces the greatest cardiac output in echocardiography for each patient enrolled
Intervention Type
Device
Intervention Name(s)
Long, fixed AV delay
Intervention Description
Pacemaker will be set to a long, fixed AV delay to minimize ventricular pacing
Intervention Type
Device
Intervention Name(s)
Short, optimized AV delay
Intervention Description
Pacemaker will be set to the AV delay that produces the greatest cardiac output in echocardiography for each patient enrolled.
Primary Outcome Measure Information:
Title
Change in cardiac output determined by echocardiography
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Changes in functional status determined by 6 minute walk.
Description
Measure distance walked in 6 minutes in meters.
Time Frame
6 months
Title
Changes in sense of well being as determined by Short Form - 36 Medical Outcomes Study Questionnaire
Description
Sense of well being score determined by answers to questions on Short Form - 36 questionnaire.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patient population: Individuals with 1st degree atrioventricular (AV) block who have received a dual chamber pacemaker for symptomatic bradycardia.
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory K Feld, MD
Organizational Affiliation
UCSD Electrophysiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Sulpizio Cardiovascular Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
15851220
Citation
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.
Results Reference
background
PubMed Identifier
19695453
Citation
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.
Results Reference
background
PubMed Identifier
10666756
Citation
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.
Results Reference
background
PubMed Identifier
20685401
Citation
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.
Results Reference
background
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AV Delay Optimization vs. Intrinsic Conduction in Pacemaker Patients With Long PR Intervals
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