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Clinical Benefit of Rigourous AV Delay Optimization in Patients With a Dual Chamber Pacemaker

NCT01998256 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2015-09-15

No results posted yet for this study

Summary

Though AV optimization has become a cornerstone in optimization of patients with a cardiac resynchronization therapy (CRT) device, surprisingly the use of AV optimization in patients with a dual chamber (bicameral (BIC)) pacemaker is not fully implemented in daily clinical practice. Some patients with a BIC pacemaker have a too short AV delay (AVD), secondary to an important interatrial conduction delay (IACD), which can lead to an atrial dyssynchrony syndrome. Others have a too long AV delay, also leading to a suboptimal diastolic filling time. Some patients may not need an optimization. Our aim was to evaluate the effect of AV optimization in all comer ambulatory patients with a BIC pacemaker on clinical outcomes, with a correlation to atrial pathophysiology, since until now existing evidence only emphasizes a possible hemodynamic benefit of this non invasive intervention.

Conditions

  • Quality of Life
  • Pacemaker Ddd Permanent
  • Atrial Dysfunction

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Jessa Hospital

    lead OTHER

Principal Investigators

  • Thijs Cools, MD · Jessa hospital, Hasselt

  • Paul Dendale, MD, PhD · Jessa hospital, Hasselt

  • Lieven Herbots, MD, PhD · Jessa hospital, Hasselt

  • Rob Geukens, MD · Jessa hospital, Hasselt

  • Jan Verwerft, MD · Jessa hospital, Hasselt

  • Tara Daerden · University Hasselt

  • Dominique Hansen, PhD · University Hasselt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01998256 on ClinicalTrials.gov