Clinical Benefit of Rigourous AV Delay Optimization in Patients With a Dual Chamber Pacemaker
NCT ID: NCT01998256
Last Updated: 2015-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2013-12-31
2014-06-30
Brief Summary
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Detailed Description
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Patients with an interatrial conduction delay may have a suboptimal left atrioventricular timing due to delayed contraction of the left atrium with foreshortening of ventricular filling. This may be an issue in pacemaker patients, with our without a substrate for heart failure. Beside the loss of reduction of left atrial contraction, it might even induce neurohormonal changes due to atrial stretch and pressure thus lowering blood pressure. Coronary sinus or multisite atrial pacing, both with the aim of synchronizing right and left atrial electrical activation, have shown to (i) improve hemodynamics in patients with an important IACD, both invasively and noninvasively, and to (ii) decrease recurrences of atrial fibrillation. In patients with a conventional BIC pacemaker, prevention of left atrioventricular asynchrony can be achieved by AV optimization (lengthening of the AV delay in case of too short nominal settings) as an alternative. Though all these interventions have proven to have positive hemodynamic results until now evidence about positive effects on clinical patient outcomes are lacking.
On the other hand, some of the patients implanted with a bicameral pacemaker have a too long AV delay. As a consequence diastolic filling time is impaired. Without compromising left atrioventricular synchrony AV delay, optimal AVD (AVO) can be achieved by lengthening of the AVD with conventional methods.
In contrast to the setting of CRT, AV optimization in patients with a bicameral (BIC) pacemaker is not fully implemented in daily clinical practice. Given the proven effect on mitral inflow on echocardiography, we wanted to evaluate the effect of this non invasive intervention on patient functionality and quality of life, based on a comprehensive assessment of atrial pathophysiology.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Group I
All patients were programmed in the same nominal AV delay settings (sensed AV delay 120ms, paced AV delay 150 ms) before randomization. Patients in group I received a sham AV optimization; patients in group II received a real AV optimization. Baseline echocardiography measurements were repeated after (sham)optimization. At 4 weeks cross-over was done by AV optimization in group I and resetting pacemaker settings to nominal values in group II. At 8 weeks patients were evaluated with the same investigations as at week 4; every pacemaker was programmed in the most optimal AV setting. All optimizations were performed by 2 unblinded echocardiographists with experience in the field.
AV optimization
Iterative DFT (diastolic filling time) method for AV optimization. Optimal AV delay for both atrial sensed and atrial paced settings was defined by two experienced echocardiographists, after 3 separate measurements.
Group II
All patients were programmed in the same nominal AV delay settings before randomization. Patients in group I received a sham AV optimization; patients in group II received a real AV optimization. Baseline echocardiography measurements were repeated after (sham)optimization. At 4 weeks cross-over was done by AV optimization in group I and resetting pacemaker settings to nominal values in group II. At 8 weeks patients were evaluated with the same investigations as at week 4; every pacemaker was programmed in the most optimal AV setting. All optimizations were performed by 2 unblinded echocardiographists with experience in the field.
AV optimization
Iterative DFT (diastolic filling time) method for AV optimization. Optimal AV delay for both atrial sensed and atrial paced settings was defined by two experienced echocardiographists, after 3 separate measurements.
Interventions
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AV optimization
Iterative DFT (diastolic filling time) method for AV optimization. Optimal AV delay for both atrial sensed and atrial paced settings was defined by two experienced echocardiographists, after 3 separate measurements.
Eligibility Criteria
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Inclusion Criteria
* Programmed in a DDD(R) modus
* Right ventricular pacing percentage of \> 50%
Exclusion Criteria
* endstage chronic obstructive lung disease
* severe psychiatric, orthopedic or neurological comorbidity
* acute illness at the moment of inclusion
* changes in cardiovascular medication the month before inclusion until the end of the study protocol
18 Years
ALL
No
Sponsors
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Jessa Hospital
OTHER
Responsible Party
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Thijs Cools
MD
Principal Investigators
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Thijs Cools, MD
Role: PRINCIPAL_INVESTIGATOR
Jessa hospital, Hasselt
Paul Dendale, MD, PhD
Role: STUDY_DIRECTOR
Jessa hospital, Hasselt
Lieven Herbots, MD, PhD
Role: STUDY_CHAIR
Jessa hospital, Hasselt
Rob Geukens, MD
Role: STUDY_CHAIR
Jessa hospital, Hasselt
Jan Verwerft, MD
Role: STUDY_CHAIR
Jessa hospital, Hasselt
Tara Daerden
Role: STUDY_CHAIR
University Hasselt
Dominique Hansen, PhD
Role: STUDY_CHAIR
University Hasselt
Locations
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Jessa Hospital
Hasselt, Limburg, Belgium
Countries
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References
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Bayés de Luna A. Electrocardiographic alterations due to atrial pathology. Clinical Electrocardiography: A Text Book. New York: Futura Company; 1998: p69.
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Other Identifiers
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not yet available
Identifier Type: -
Identifier Source: org_study_id
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