NCT00704093

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 24, 2008

Completed
Last Updated

July 4, 2008

Status Verified

July 1, 2008

Enrollment Period

5 months

First QC Date

June 23, 2008

Last Update Submit

July 3, 2008

Conditions

Bradycardia

Keywords

pacingperfusionoxidative metabolismefficiency

Outcome Measures

Primary Outcomes (1)

  • myocardial perfusion, oxidative metabolism and efficiency

    At baseline and at 2 hours

Interventions

Right ventricular pacingDEVICE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pacemaker dependency
  • Symptomatic coronary artery disease
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku PET Centre

Turku, 20520, Finland

Location

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Juhani Knuuti, MD, prof

    Turku PET Centre

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 23, 2008

First Posted

June 24, 2008

Study Start

January 1, 2008

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

July 4, 2008

Record last verified: 2008-07

Locations

FI(1)