Status:

COMPLETED

Acute Impact of Cardiac Resynchronization on Vascular Function (RVA-CRT)

Lead Sponsor:

Andreas Flammer

Conditions:

Heart Failure

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Evaluation of the effect of short term activation/deactivation of biventricular pacing (BivP) of the CRT (during routine CRT interrogation) on vascular function as assessed via retinal vessel analysis...

Detailed Description

Heart failure is a condition in which the heart becomes unable to maintain the body's need of blood supply. Congestive heart failure can be considered a syndrome but the final common path of many card...

Eligibility Criteria

Inclusion

  • Informed Consent as documented by signature
  • Patients ≥ 18 years of age, male or female, diagnosed with advanced heart failure
  • Implanted as well as activated CRT device for at least 3 months prior to Visit 1

Exclusion

  • Current acute decompensated HF
  • Documented pacing dependency
  • Documented AV-Block II (Mobitz Typ 2) or III in patient's history
  • History of hypersensitivity or allergy to Tropicamide
  • Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major cardiovascular (CV) surgery, percutaneous coronary intervention (PCI) or carotid angioplasty within 3 months prior to Visit 1.
  • History of heart transplant, on a transplant list or with ventricular assistance device (VAD).
  • Presence of any other disease with a life expectancy of \< 6 months
  • Presence of significant endocrine diseases, including primary hyperparathyroidism, Cushing's disease, adrenal insufficiency, pituitary tumors, primary hyperaldosteronism, manifest hyperthyroidism or genetic endocrine disorders
  • Presence of active acute infectious diseases.
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc
  • Women who are pregnant or breast feeding
  • Known narrow-angle glaucoma
  • Known epilepsy (flicker-light could trigger a seizure)

Key Trial Info

Start Date :

January 1 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 20 2023

Estimated Enrollment :

35 Patients enrolled

Trial Details

Trial ID

NCT04379401

Start Date

January 1 2021

End Date

June 20 2023

Last Update

August 1 2023

Active Locations (1)

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1

UniversitätsSpital Zürich

Zurich, Switzerland, 8091