Trials / Completed
CompletedNCT04068233
Impact of Pacing Mode and Diastolic Function on Cardiac Output
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Kepler University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Pacemaker stimulation mode | Echocardiographic indices are measured during AV asynchronous and AV synchronous pacemaker stimulation. |
Timeline
- Start date
- 2019-06-26
- Primary completion
- 2020-02-05
- Completion
- 2020-02-05
- First posted
- 2019-08-28
- Last updated
- 2020-02-21
Locations
1 site across 1 country: Austria
Source: ClinicalTrials.gov record NCT04068233. Inclusion in this directory is not an endorsement.