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Impact of Pacing Mode and Diastolic Function on Cardiac Output

NCT04068233 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-02-21

No results posted yet for this study

Summary

Background It is known from previous research that in patients with complete AV (atrioventricular) block and pacemaker stimulation stroke volume and cardiac output are higher with AV-synchronous than with AV-dyssynchronous pacing. However, the extent to which patients profited from AV-synchronous stimulation varied substantially.

Aim of the study Aim of this study is to systematically analyze the impact of diastolic function and other echo parameters on the difference of stroke volumes/cardiac output between AV-synchronous and AV-dyssynchronous pacing modes.

Methods Patients fulfilling the entry criteria will be enrolled (two-chamber pacemaker of any vendor eligible) in this monocentric, prospective, interventional study. Baseline data will be collected with a standardized questionnaire. During an echo examination, parameters of diastolic, systolic and atrial function will be assessed. Then, the stroke volume/cardiac output will be measured twice in each patient, once with AV-synchronous and once with AV-dyssynchronous pacing. Therefore, each patient will represent their own control. It will be randomized (coin tossing) which stimulation mode is first and which is second (sonographer and patient will be blinded). Descriptive statistics will be applied and regression models will be fitted to explore the data.

Conditions

  • Diastolic Function
  • Cardiac Output
  • Pacemaker Stimulation Mode
  • Stroke Volume
  • AV Block

Interventions

OTHER

Pacemaker stimulation mode

Echocardiographic indices are measured during AV asynchronous and AV synchronous pacemaker stimulation.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Kepler University Hospital

    lead OTHER

Principal Investigators

  • Clemens Steinwender, Assoc. Prof., MD · Kepler University Hospital, Department of Cardiology

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-26
Primary Completion
2020-02-05
Completion
2020-02-05

Countries

  • Austria

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 NCT04068233 on ClinicalTrials.gov