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The Tilt Test-Induced REsponse in Closed-loop Stimulation (TIRECS) Study

NCT02573649 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-04-05

No results posted yet for this study

Summary

Multicentre, prospective, double blinded, randomized study designed as an intrapatient comparison to evaluate the effects of the Biotronik Closed-loop Stimulation algorithm on prevalence and timing of haemodynamic variations and clinical prodromes induced by head-up tilt test in patients underwent pacemaker implantation for refractory cardioinhibitory vasovagal syncope.

Conditions

  • Syncope, Vasovagal, Neurally-Mediated

Interventions

DEVICE

Closed-loop Stimulation on first

Closed-loop Stimulation algorithm is turned on in the device. The patient performs a head up tilt test. After a week Closed-loop Stimulation algorithm is turned off and the patient performs a second head up tilt test.

DEVICE

Closed-loop Stimulation off first

Closed-loop Stimulation algorithm is turned off in the device. The patient performs a head up tilt test. After a week Closed-loop Stimulation algorithm is turned on and the patient performs a second head up tilt test.

Sponsors & Collaborators

  • Azienda Ospedaliera Cardinale G. Panico

    lead OTHER

Principal Investigators

  • Pietro Palmisano, MD · Cardiology Unit, Card G. Panico Hospital, Tricase, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02573649 on ClinicalTrials.gov