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

April 1, 2016 updated by: Pietro Palmisano, Azienda Ospedaliera Cardinale G. Panico

Effects of Closed-loop Stimulation vs. DDD Pacing on Prevalence and Timing of Haemodynamic Variations and Clinical Prodromes Induced by Head-up Tilt Test in Patients With Refractory Cardioinhibitory Vasovagal Syncope. The TIRECS Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A total of 30 patients with refractory cardioinhibitory vasovagal syncope receiving a Biotronik pacemaker with Closed-loop Stimulation (CLS) algorithm will be enrolled in the study. Two head-up tilt test (HUTT), one during DDD 60/min pacing with CLS algorith turned off (CLS-OFF) and the other during DDD-CLS pacing (CLS-ON), will be performed one week apart; patients will be randomly and blindly assigned to group A (n=15, first HUTT in CLS-ON mode) or B (n=15, first HUTT in CLS-OFF mode). During HUTT heart rate, blood pressure, and the incidence of clinical prodromes and syncope wil be recorded.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Novara, Italy
        • Dell'Era Gabriele
    • Lecce
      • Tricase, Lecce, Italy, 73039
        • Pietro Palmisano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Refractory cardioinhibitory vasovagal syncope treated with permanent pacemaker;
  • Pacemaker Biotronik with Closed-loop Stimulation algorithm
  • Ability to perform a head up tilt test
  • Completion of the 18th year of age

Exclusion Criteria:

  • Contraindications to head up tilt test

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CLS-ON first
Closed-loop Stimulation on first
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.
Active Comparator: CLS-OFF first
Closed-loop Stimulation off first
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Haemodynamic response during head up tilt test.
Time Frame: 45 minutes
Assessment of the values of systolic blood pressure
45 minutes
Incidence of prodromal symptoms during head up tilt test.
Time Frame: 45 minutes
Assessment of patient-reported symptoms during the test
45 minutes
Incidence of syncope during head up tilt test.
Time Frame: 45 minutes
Assessment of patient-reported symptoms during the test
45 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera Cardinale G. Panico

Investigators

  • Principal Investigator: Pietro Palmisano, MD, Cardiology Unit, Card G. Panico Hospital, Tricase, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

August 9, 2015

First Submitted That Met QC Criteria

October 9, 2015

First Posted (Estimate)

October 12, 2015

Study Record Updates

Last Update Posted (Estimate)

April 5, 2016

Last Update Submitted That Met QC Criteria

April 1, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TIRECS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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