Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2026-02-21 @ 4:08 PM
Study NCT ID:
NCT02154750
Status:
COMPLETED
Last Update Posted:
2025-07-24
First Post:
2014-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
AV Delay Optimization vs. Intrinsic Conduction in Pacemaker Patients With Long PR Intervals
Sponsor:
Organization:
Raw JSON
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A reduction LV dimension indicates improvement in function, and an increase in tricuspid annular plane excursion represents an improvement in function.'}, {'measure': '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.', 'timeFrame': '6 months', 'description': '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.'}, {'measure': "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.", 'timeFrame': '6 months', 'description': "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,"}, {'measure': 'Comparison of Echocardiographic Parameter Deceleration Time (Msec) at Baseline and Followup, in Optimized AV Delay Versus Long-fixed AV Delay Group.', 'timeFrame': '6 months', 'description': '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.'}, {'measure': '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.', 'timeFrame': '6 months', 'description': '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.'}, {'measure': '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.', 'timeFrame': '6 months', 'description': '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. 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A reduction in left ventricular mass represents an improvement in function.'}], 'secondaryOutcomes': [{'measure': '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.', 'timeFrame': '6 months', 'description': '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. An increase in distance walked during the 6 minute walk test represents an improvement in function.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Atrioventricular delay', 'AV delay', 'Pacemaker', 'Sick Sinus Syndrome', 'Bradycardia', 'PR interval', 'Atrioventricular block', 'AV block', 'Echocardiography', 'Arrhythmia', 'AV optimization'], 'conditions': ['Atrioventricular Block', 'Sick Sinus Syndrome', 'Symptomatic Bradycardia', 'Cardiac Arrhythmia']}, 'referencesModule': {'references': [{'pmid': '15851220', 'type': 'BACKGROUND', '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.'}, {'pmid': '19695453', 'type': 'BACKGROUND', '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.'}, {'pmid': '10666756', 'type': 'BACKGROUND', '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.'}, {'pmid': '20685401', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.\n\nMany 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.\n\nThe 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.\n\nPatients 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Patient population: Individuals with 1st degree atrioventricular (AV) block who have received a dual chamber pacemaker for symptomatic bradycardia.\n\nInclusion Criteria:\n\n1. Patients greater than 18 years of age\n2. Patients with symptomatic sinus bradycardia\n3. Patients who meet standard indications for dual chamber pacemaker implantation\n4. Patients who have 1st degree AV block determined by PR interval \\> 200ms\n\nExclusion Criteria:\n\n1. Patients with complete or high grade AV block\n2. Patients who are unable to complete dual chamber pacemaker implantation for any reason\n3. Patients with congestive heart failure determined by a Left Ventricular Ejection Fraction \\< 45%\n4. Patients with persistent atrial fibrillation\n5. Sustained premature ventricular contractions (PVCs), premature atrial contractions (PACs), atrial flutter, or other heart conditions that may interfere with echocardiography measurements\n6. Patients who are pregnant\n7. Patients with Paroxysmal Atrial Fibrillation that have had an episode(s) within 30 days of consent'}, 'identificationModule': {'nctId': 'NCT02154750', 'acronym': 'AV Delay', 'briefTitle': 'AV Delay Optimization vs. Intrinsic Conduction in Pacemaker Patients With Long PR Intervals', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Evaluation of AV Delay Optimization vs. Intrinsic Conduction in Patients With Long PR Intervals Receiving Dual Chamber Pacemakers for Symptomatic Bradycardia', 'orgStudyIdInfo': {'id': '130663'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Long, fixed AV delay', 'description': 'Pacemaker will be set to a long, fixed AV delay to minimize ventricular pacing', 'interventionNames': ['Device: Long, fixed AV delay']}, {'type': 'EXPERIMENTAL', 'label': 'Short, optimized AV delay', 'description': 'Pacemaker will be set to the AV delay that produces the greatest cardiac output in echocardiography for each patient enrolled', 'interventionNames': ['Device: Short, optimized AV delay']}], 'interventions': [{'name': 'Long, fixed AV delay', 'type': 'DEVICE', 'description': 'Pacemaker will be set to a long, fixed AV delay to minimize ventricular pacing', 'armGroupLabels': ['Long, fixed AV delay']}, {'name': 'Short, optimized AV delay', 'type': 'DEVICE', 'description': 'Pacemaker will be set to the AV delay that produces the greatest cardiac output in echocardiography for each patient enrolled.', 'armGroupLabels': ['Short, optimized AV delay']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UCSD Sulpizio Cardiovascular Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}], 'overallOfficials': [{'name': 'Gregory K Feld, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCSD Electrophysiology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Greg Feld', 'investigatorAffiliation': 'University of California, San Diego'}}}}