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

Primary Purpose

Diastolic Function, Cardiac Output, Pacemaker Stimulation Mode

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Pacemaker stimulation mode
Sponsored by
Kepler University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diastolic Function focused on measuring Diastolic function, Cardiac output, Pacemaker stimulation mode, Stroke volume

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Kepler University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Eligible patients - pacing mode sequence 1

Eligible patients - pacing mode sequence 2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Effect of left ventricular systolic function on the change of cardiac output between AV-synchronous and AV-asynchronous pacing modes.
Echo parameters of systolic function.
Effect of atrial function on the change of cardiac output between AV-synchronous and AV-asynchronous pacing modes.
Echo parameters of atrial function.
Effect of baseline characteristics on the change of cardiac output between AV-synchronous and AV-asynchronous pacing modes.
Demographic variables and co-morbidities.

Full Information

First Posted
August 22, 2019
Last Updated
February 20, 2020
Sponsor
Kepler University Hospital
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT04068233
Brief Title
Impact of Pacing Mode and Diastolic Function on Cardiac Output
Acronym
PADIAC
Official Title
Impact of Pacing Mode and Diastolic Function on Cardiac Output
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
June 26, 2019 (Actual)
Primary Completion Date
February 5, 2020 (Actual)
Study Completion Date
February 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kepler University Hospital
Collaborators
Medtronic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diastolic Function, Cardiac Output, Pacemaker Stimulation Mode, Stroke Volume, AV Block
Keywords
Diastolic function, Cardiac output, Pacemaker stimulation mode, Stroke volume

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Each patient will represent their own control, as both pacing modes (asynchronous and synchronous) are applied in each patient.
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eligible patients - pacing mode sequence 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Eligible patients - pacing mode sequence 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Pacemaker stimulation mode
Intervention Description
Echocardiographic indices are measured during AV asynchronous and AV synchronous pacemaker stimulation.
Primary Outcome Measure Information:
Title
Effect of left ventricular diastolic function on the change of cardiac output between AV-synchronous and AV-asynchronous pacing modes.
Description
Echo parameters of diastolic function.
Time Frame
During echo examination.
Secondary Outcome Measure Information:
Title
Effect of left ventricular systolic function on the change of cardiac output between AV-synchronous and AV-asynchronous pacing modes.
Description
Echo parameters of systolic function.
Time Frame
During echo examination.
Title
Effect of atrial function on the change of cardiac output between AV-synchronous and AV-asynchronous pacing modes.
Description
Echo parameters of atrial function.
Time Frame
During echo examination.
Title
Effect of baseline characteristics on the change of cardiac output between AV-synchronous and AV-asynchronous pacing modes.
Description
Demographic variables and co-morbidities.
Time Frame
During echo examination.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clemens Steinwender, Assoc. Prof., MD
Organizational Affiliation
Kepler University Hospital, Department of Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kepler University Hospital
City
Linz
State/Province
Upper Austria
ZIP/Postal Code
4020
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of Pacing Mode and Diastolic Function on Cardiac Output

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