NCT01112176

Brief Summary

The current study is aimed at determining the normal response to increasing heart rates. For this purpose, atrial pacing will be used to increase heart rate.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2010

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2010

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 28, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

April 28, 2010

Status Verified

April 1, 2010

Enrollment Period

2 years

First QC Date

April 13, 2010

Last Update Submit

April 27, 2010

Conditions

Myocardial FunctionMyocardial Strain

Keywords

StrainEjection fractionDiastolic function

Outcome Measures

Primary Outcomes (1)

  • Segmental Strain

    Segmental Strain by speckle tracking method will be calculated for every stage of each study.

    approx. 20 minutes

Secondary Outcomes (1)

  • LV function

    Approx. 20 minutes

Interventions

Increase in paced heart ratePROCEDURE

The pacing rate will be increased by 10 bps at every stage

Eligibility Criteria

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

You may qualify if:

  • Patients with AAI or DDD pacemaker with intact AV nodal conduction that can be set to work in AAI mode.
  • Stable rhythm (either sinus or paced).
  • Good quality baseline echo.
  • Able and willing to sign Informed Consent Form.

You may not qualify if:

  • Prior heart failure or ischemic heart disease.
  • Severe valvular lesions.
  • Severe pulmonary hypertension.
  • Known intolerance to rapid pacing.
  • Multiple extrasystoles (more than 1 per echo or monitor screen).
  • Age over 70.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hille Yaffe Medical Ceter

Hadera, Israel, 38100, Israel

RECRUITING

MeSH Terms

Conditions

Sprains and Strains

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • David S. Blondheim, MD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David S. Blondheim, MD

CONTACT

97246304488davidb@hy.health.gov.il

David S. Blondheim, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

April 13, 2010

First Posted

April 28, 2010

Study Start

April 1, 2010

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

April 28, 2010

Record last verified: 2010-04

Locations

IL(1)