The Tilt Test-Induced REsponse in Closed-loop Stimulation (TIRECS) Study
TIRECS
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
1 other identifier
interventional
30
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2015
Shorter than P25 for not_applicable
2 active sites
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
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 9, 2015
CompletedFirst Posted
Study publicly available on registry
October 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedApril 5, 2016
April 1, 2016
7 months
August 9, 2015
April 1, 2016
Conditions
Outcome Measures
Primary Outcomes (3)
Haemodynamic response during head up tilt test.
Assessment of the values of systolic blood pressure
45 minutes
Incidence of prodromal symptoms during head up tilt test.
Assessment of patient-reported symptoms during the test
45 minutes
Incidence of syncope during head up tilt test.
Assessment of patient-reported symptoms during the test
45 minutes
Study Arms (2)
CLS-ON first
ACTIVE COMPARATORClosed-loop Stimulation on first
CLS-OFF first
ACTIVE COMPARATORClosed-loop Stimulation off first
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Contraindications to head up tilt test
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Pietro Palmisano
Tricase, Lecce, 73039, Italy
Dell'Era Gabriele
Novara, Novara, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pietro Palmisano, MD
Cardiology Unit, Card G. Panico Hospital, Tricase, Italy
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- physician
Study Record Dates
First Submitted
August 9, 2015
First Posted
October 12, 2015
Study Start
April 1, 2015
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
April 5, 2016
Record last verified: 2016-04