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

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.

Study Overview

• Status: Completed
• Conditions: Diastolic Function; Cardiac Output; AV Block; Pacemaker Stimulation Mode; Stroke Volume
• Intervention / Treatment: Other: Pacemaker stimulation mode

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Upper Austria
    • Linz, Upper Austria, Austria, 4020
      • Kepler University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During echo examination.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During echo examination.
Effect of atrial function on the change of cardiac output between AV-synchronous and AV-asynchronous pacing modes.	Echo parameters of atrial function.	During echo examination.
Effect of baseline characteristics on the change of cardiac output between AV-synchronous and AV-asynchronous pacing modes.	Demographic variables and co-morbidities.	During echo examination.

Collaborators and Investigators

• Sponsor: Kepler University Hospital
• Collaborators: Medtronic
• Investigators: Principal Investigator: Clemens Steinwender, Assoc. Prof., MD, Kepler University Hospital, Department of Cardiology

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2019
• Primary Completion (Actual): February 5, 2020
• Study Completion (Actual): February 5, 2020

Study Registration Dates

• First Submitted: August 22, 2019
• First Submitted That Met QC Criteria: August 22, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): February 21, 2020
• Last Update Submitted That Met QC Criteria: February 20, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Cardiac output; Stroke volume; Diastolic function; Pacemaker stimulation mode
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Block; Atrioventricular Block
• Other Study ID Numbers: 01/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No