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Impact of Pacing Mode and Diastolic Function on Cardiac Output (PADIAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04068233
Recruitment Status : Completed
First Posted : August 28, 2019
Last Update Posted : February 21, 2020
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Clemens Steinwender, Kepler University Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Diastolic Function Cardiac Output Pacemaker Stimulation Mode Stroke Volume AV Block Other: Pacemaker stimulation mode Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Each patient will represent their own control, as both pacing modes (asynchronous and synchronous) are applied in each patient.
Masking: Double (Participant, Investigator)
Masking Description: It is decided by coin tossing which pacing mode is programmed first (randomization). Sonographer and patient are both blinded to the pacing mode.
Primary Purpose: Basic Science
Official Title: Impact of Pacing Mode and Diastolic Function on Cardiac Output
Actual Study Start Date : June 26, 2019
Actual Primary Completion Date : February 5, 2020
Actual Study Completion Date : February 5, 2020

Arm Intervention/treatment
Experimental: Eligible patients - pacing mode sequence 1
Echo assessment of parameters of diastolic function, systolic function, and atrial function. Then, the stroke volume and cardiac output are measured during AV-asynchronous and AV-synchronous pacemaker stimulation: AV-synchronous pacing mode first, then AV-dyssynchronous pacing mode.
Other: Pacemaker stimulation mode
Echocardiographic indices are measured during AV asynchronous and AV synchronous pacemaker stimulation.

Experimental: Eligible patients - pacing mode sequence 2
Echo assessment of parameters of diastolic function, systolic function, and atrial function. Then, the stroke volume and cardiac output are measured during AV-asynchronous and AV-synchronous pacemaker stimulation: AV-dyssynchronous pacing mode first, then AV-synchronous pacing mode.
Other: Pacemaker stimulation mode
Echocardiographic indices are measured during AV asynchronous and AV synchronous pacemaker stimulation.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04068233


Locations
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Austria
Kepler University Hospital
Linz, Upper Austria, Austria, 4020
Sponsors and Collaborators
Kepler University Hospital
Medtronic
Investigators
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Principal Investigator: Clemens Steinwender, Assoc. Prof., MD Kepler University Hospital, Department of Cardiology
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Responsible Party: Clemens Steinwender, Head of the Department of Cardiology, Kepler University Hospital
ClinicalTrials.gov Identifier: NCT04068233    
Other Study ID Numbers: 01/2019
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Clemens Steinwender, Kepler University Hospital:
Diastolic function
Cardiac output
Pacemaker stimulation mode
Stroke volume
Additional relevant MeSH terms:
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Atrioventricular Block
Cardiovascular Diseases
Heart Block
Arrhythmias, Cardiac
Heart Diseases
Cardiac Conduction System Disease
Pathologic Processes