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Completed

NCT Number: NCT04068233

Impact of Pacing Mode and Diastolic Function on Cardiac Output

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.

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Key information

Conditions

Diastolic Function AV Block Arrhythmias, Cardiac Atrioventricular Block Cardiac Conduction System Disease Cardiac Output Cardiovascular Diseases Heart Block Heart Diseases Pacemaker Stimulation Mode Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Volume

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kepler University Hospital

Linz, Upper Austria, 4020, Austria

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patient is able and willing to give informed consent and is above the age of 18.
  • Patient is implanted with a dual chamber pacemaker system for at least 6 weeks.
  • Patient is in sinus rhythm on the day of recruitment.
  • Patient has a ventricular pacing rate exceeding 90%.
  • Upon initial device interrogation, parameters are within normal ranges.
  • Calculated battery life is more than 1 year.

Exclusion criteria

  • Patient is not in sinus rhythm on the day of echo examination.
  • Intrinsic ventricular activation on the day of echo examination.
  • Relevant shunt on the atrial, ventricular or pulmonary level.
  • Moderate or severe heart valve dysfunction (stenosis or regurgitation).
  • Presence of other medical devices that may interact with the pacemaker system.
  • Women who are pregnant or breast feeding.

Treatment and study plan

Pacemaker stimulation mode

Other

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

Primary outcomes

  1. Effect of left ventricular diastolic function on the change of cardiac output between AV-synchronous and AV-asynchronous pacing modes.

    Time frame: During echo examination.

    Echo parameters of diastolic function.

Secondary outcomes

  1. Effect of left ventricular systolic function on the change of cardiac output between AV-synchronous and AV-asynchronous pacing modes.

    Time frame: During echo examination.

    Echo parameters of systolic function.

  2. Effect of atrial function on the change of cardiac output between AV-synchronous and AV-asynchronous pacing modes.

    Time frame: During echo examination.

    Echo parameters of atrial function.

  3. Effect of baseline characteristics on the change of cardiac output between AV-synchronous and AV-asynchronous pacing modes.

    Time frame: During echo examination.

    Demographic variables and co-morbidities.

Sponsors and collaborators

Lead sponsor

Kepler University Hospital

Other

Collaborators

  • Medtronic

Registry information

Acronym: PADIAC

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 28, 2019
Registry last updated
Feb 21, 2020

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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