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Completed

NCT Number: NCT00704093

The Effect of Right Ventricular Pacing on Myocardial Oxidative Metabolism and Efficiency

Right ventricular (RV) apical pacing induces a left bundle branch block (LBBB) type electrical activation sequence in the heart. This abnormal activation pattern of the ventricles may have detrimental effects on cardiac structure and function. RV pacing has been shown to impair left ventricular (LV) function both in normal and failing hearts. Importantly, it has been demonstrated that this deterioration in LV function is related to the presence of LV dyssynchrony during RV pacing.

The exact effects of RV pacing on myocardial perfusion, oxidative metabolism and cardiac efficiency have not been fully elucidated. The objective of the present study is to evaluate the effect of RV pacing on both global and regional oxidative metabolism and perfusion, and myocardial efficiency. In addition, the effect of RV pacing induced LV dyssynchrony on myocardial oxidative metabolism and efficiency will be studied.

Our hypothesis is that LV dyssynchrony during RV pacing results in regional abnormalities in LV perfusion and oxidative metabolism. LV dyssynchrony will also result in altered myocardial efficiency.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Turku PET Centre

Turku, 20520, Finland

About this study

Right ventricular (RV) apical pacing induces a left bundle branch block (LBBB) type electrical activation sequence in the heart. This abnormal activation pattern of the ventricles may have detrimental effects on cardiac structure and function. Several clinical trials have demonstrated an association between RV pacing and an increased risk of heart failure and death. In addition, RV pacing has been shown to impair left ventricular (LV) function both in normal and failing hearts. Importantly, it has been demonstrated that this deterioration in LV function is related to the presence of LV dyssynchrony during RV pacing.

The exact effects of RV pacing on myocardial perfusion, oxidative metabolism and cardiac efficiency have not been fully elucidated. Importantly, the relation between the presence of LV dyssynchrony during RV pacing and changes in myocardial perfusion, oxidative metabolism and cardiac efficiency has not been studied.

Ten patients with normal LV ejection fraction and VVI/DDD pacemaker will be studied during AAI-pacing/sinus rhythm without RV pacing (pacing-OFF) and with RV-pacing (pacing-ON) at the same heart rate. Dynamic [15O]water and [11C]acetate positron emission tomography is used to measure perfusion and oxidative metabolism (kmono) of the LV. An echocardiographic examination is used to assess LV stroke volume (SV) and LV dyssynchrony.

The PET data will be first analyzed based on RV pacing mode only, comparing the two pacing conditions (pacing-ON vs. pacing-OFF). Thereafter, the study population will be divided into two groups, according to the presence of LV dyssynchrony during RV pacing.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed consent
  • Age over 18 years
  • Previously implanted permanent pacemaker (DDD or VVI)
  • Normal left ventricular function

Exclusion criteria

  • Pacemaker dependency
  • Symptomatic coronary artery disease
  • Pregnancy

Treatment and study plan

Right Ventricular Pacing

Device

Right ventricular pacing vs. sinus rhythm or atrial pacing at the same rate

Primary outcomes

  1. myocardial perfusion, oxidative metabolism and efficiency

    Time frame: At baseline and at 2 hours

Sponsors and collaborators

Lead sponsor

University of Turku

Other

Collaborators

  • Leiden University Medical Center

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 24, 2008
Registry last updated
Jul 4, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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