NCT03665558

Brief Summary

The maximum value of rate of left ventricular pressure increase, denoted by left ventricular peak dP/dt value (dP/dt max), corresponds to the highest point on the curve of first derivative of ventricular pressure curve with respect to time. It is one of the important systolic performance parameters, which is primarily determined by ventricular contractility, and emerges in isovolumetric contraction phase when aortic valves are closed. Thus it is not influenced by parameters beyond ventricle such as aortic valve area, aortic elastance and peripheral resistance. Despite these unique advantageous, the main reason for its limited usage in assessing ventricular systolic performance instead of commonly used ejection fraction is the difficulties in its calculation, which requires incessant intraventricular pressure recordings. The maximum value of acceleration rate of aortic pressure increase can be named as aortic peak dP/dt. It, likewise, corresponds to the maximum value of first derivative of pressure curve with respect to time. Since it is one of the principal determining factors of aortic peak dP/dt, changing left ventricular contractility thereby left ventricular peak dP/dt value is expected to change aortic peak dP/dt in the same direction since all other variables being unchanged. Yet to conclude the extent of this association and magnitude of change, measuring these parameters for various contractility levels is necessary. In addition, impact of decreasing left ventricular peak dP/dt by gradually lowering ventricular contractility upon aortic peak dP/dt has not been investigated in previous studies. In the present study, changes in left ventricular and aortic peak dP/dt values in response to gradual reduction in LV contractility with stepwise changing (decremental shortening) atrio-ventricular delay (AVD) by dual chamber pacing will be investigated in patients without systolic dysfunction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 3, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 11, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2018

Completed
Last Updated

October 30, 2018

Status Verified

September 1, 2018

Enrollment Period

1 month

First QC Date

September 5, 2018

Last Update Submit

October 28, 2018

Conditions

Keywords

Ventricular contractilityPacingVentricular dP/dtAortic dP/dt

Outcome Measures

Primary Outcomes (1)

  • Changing in aortic dP/dt in response to DDD pacing

    Changing in aortic dP/dt in response to DDD pacing will be determined

    At the end of the stepwise pacing procedure completed

Study Arms (2)

Aortic dP/dt in sinus rhythm

NO INTERVENTION

Left ventricular and aortic dP/dt values were recorded at baseline condition while patients are on sinus rhythm.

Aortic dP/dt during DDD pacing

ACTIVE COMPARATOR

Patients will be their own control. Aortic and ventricular pressures will be recorded under temporary DDD pacing again and these data collected at every pacing steps will be compared to the pressures recorded at baseline condition.

Device: Temporary DDD pacing

Interventions

Measurements will be performed in patients otherwise undergoing invasive catheterization procedure. Baseline ventricular and aortic hemodynamic parameters (continuous pressure recordings) will be recorded. Thereafter, DDD pacing with stepwise changing of the AV delay will be performed. During each pacing steps left ventricular and aortic pressures at different aortic levels will be continuously recorded. From these hemodynamic data, left ventricular and aortic dP/dt values will be calculated off line.

Aortic dP/dt during DDD pacing

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Normal left ventricular systolic function

You may not qualify if:

  • Abnormal left ventricular systolic function with ejection fraction \< 50%
  • Presence of severe coronary artery disease
  • Presence of valvular heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology

Istanbul, 34290, Turkey (Türkiye)

Location

Related Publications (1)

  • Sezer M, Atici A, Coskun I, Cizgici Y, Ozcan A, Umman B, Bugra Z, Ozcan I, Hasdemir H, Kocaaga M, Davies JE, Umman S. Reducing Aortic Barotrauma and Vascular Extracellular Matrix Degradation by Pacemaker-Mediated QRS Widening. J Am Heart Assoc. 2020 May 18;9(10):e014804. doi: 10.1161/JAHA.119.014804. Epub 2020 May 11.

MeSH Terms

Conditions

Aortic Diseases

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

September 5, 2018

First Posted

September 11, 2018

Study Start

September 3, 2018

Primary Completion

October 15, 2018

Study Completion

October 15, 2018

Last Updated

October 30, 2018

Record last verified: 2018-09

Locations