Head-up Tilt Test in Patients With Reflex Syncope and Asystolic Response Who Received a Dual-chamber Pacemaker With the Closed Loop Stimulation (CLS) and Participated in the BIOSync Trial

NCT06038708 | Completed Results

• 1 other identifier: BA117
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to explore changes in patients' hemodynamic parameters during the Head-Up Tilt Test ("HUTT") and their timing with respect to onset of the Closed Loop Stimulation (CLS) pacing. This study aims to add knowledge to better understand the mechanisms underlying recurrent syncopal events and optimal pacing programming.

Conditions

Syncope; Syncope, Vasovagal

Keywords

Syncope; Head-up Tilt Test; Closed Loop Stimulation; CLS

Outcome Measures

Primary Outcomes (12)

• Heart Rate [Bpm] at Specific Time-points During Head-up Tilt Test (HUTT) Examination

  Instantaneous measurement of heart rate value at specific time-points/stages during HUTT examination. Changes in Heart rate were investigated across four stages of the HUTT: baseline (Stage 1), pre-syncopal phase (Stage 2), maximum heart rate/pacing rate (Stage 3), and syncope or lowest Systolic Blood Pressure (Stage 4).

  From the start to the end of the HUTT examination, assessed up to 45 minutes

• Systolic Blood Pressure at Specific Time-points During Head-up Tilt Test (HUTT) Examination

  Instantaneous measurement of blood pressure at specific time-points during HUTT examination. Changes in Systolic blood pressure were investigated across four stages of the HUTT: baseline (Stage 1), pre-syncopal phase (Stage 2), maximum heart rate/pacing rate (Stage 3), and syncope or lowest Systolic Blood Pressure (Stage 4).

  From the start to the end of the HUTT examination, assessed up to 45 minutes

• Stroke Volume [ml] at Specific Time-points During Head-up Tilt Test (HUTT)

  Instantaneous measurement of stroke volume at specific time-points during HUTT examination

  From the start to the end of the HUTT examination, assessed up to 45 minutes

• Peripheral Resistance [Dyn·s/cm5] at Specific Time-points During Head-up Tilt Test (HUTT)

  Instantaneous measurement of peripheral resistance at specific time-points during HUTT examination

  From the start to the end of the HUTT examination, assessed up to 45 minutes

• Time of Maximum Spontaneous Heart Rate

  Recording of a specific time-point during HUTT examination. This time was collected as hours:minutes:seconds (e.g. 00:35:34).

  From the start to the end of the HUTT examination, assessed up to 45 minutes

• Time of Pacing Onset

  Recording of a specific time-point during HUTT examination. This time was collected as hours:minutes:seconds (e.g. 00:35:34).

  From the start to the end of the HUTT examination, assessed up to 45 minutes

• Time of Recovery of Spontaneous Rhythm After Pacing

  Recording of a specific time-point during HUTT examination. This time was collected as hours:minutes:seconds (e.g. 00:35:34).

  From the start to the end of the HUTT examination, assessed up to 45 minutes

• Time of Syncope

  Recording of a specific time-point during HUTT examination. This time was collected as hours:minutes:seconds (e.g. 00:35:34).

  From the start to the end of the HUTT examination, assessed up to 45 minutes

• Time of Tilt-down

  Recording of a specific time-point during HUTT examination. This time was collected as hours:minutes:seconds (e.g. 00:35:34).

  From the start to the end of the HUTT examination, assessed up to 45 minutes

• Duration of the Recovery Phase [Minutes]

  Interval from maximum pacing rate to basic rate or spontaneous rhythm

  From the start to the end of the HUTT examination, assessed up to 45 minutes

• Slope in Heart Rate [Bpm/Minute] During the Recovery Phase

  Calculation of the rate of change of heart rate from the time of maximum pacing rate to the time of basic rate or spontaneous rhythm recovery

  From the start to the end of the HUTT examination, assessed up to 45 minutes

• Slope in Systolic Blood Pressure (mmHg Per Minute) During the Recovery Phase

  Calculation of the rate of change of systolic blood pressure from the time of maximum pacing rate to the time of basic rate or spontaneous rhythm recovery

  From the start to the end of the HUTT examination, assessed up to 45 minutes

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with reflex syncope and positive cardioinhibitory response to Head-Up Tilt Test (HUTT) who had already participated in the BIOSync study.

You may qualify if:

• Ability to understand the nature of the study.
• Willingness to provide written informed consent.
• Patients undergoing HUTT for monitoring of syncope, therapy adjustment, training or other medical reasons during ordinary follow-up, irrespective of study participation
• Patients who participated in the BIOSync study\*.

You may not qualify if:

• Pregnant or breast feeding women.
• Age less than 40 years.
• Patients who after the BIOSync study participation have developed the following:
• Any indication to pacemaker different from reflex syncope with positive HUTT response; or
• Any classified indication to implantable defibrillator, cardiac resynchronization therapy according to current guidelines; or
• Any cardiac dysfunctions likely leading to loss of consciousness (overt heart failure, ejection fraction \<40%, myocardial infarction, diagnosis of hypertrophic or dilated cardiomyopathy, clinically significant valvular disease, sinus bradycardia \<50 bpm or sinoatrial block, Mobitz I second degree atrioventricular block, Mobitz II second or third degree atrioventricular block, complete bundle-branch block).

Sponsors & Collaborators

• Biotronik SE & Co. KG: lead

Study Sites (2)

Ospedale di Bolzano - Azienda Sanitaria dell'Alto Adige

Bolzano, 39100, Italy

Location

Monaldi - AORN dei Colli - Università della Campania "Luigi Vanvitelli"

Napoli, 80131, Italy

Location

Related Publications (1)

• Russo V, Tomaino M, Parente E, Comune A, Giacopelli D, Napoli P, Gargaro A, Brignole M. Temporal relationship between haemodynamic changes and activation of closed-loop stimulation during a tilt-induced vasovagal syncope. Europace. 2024 Feb 1;26(2):euae045. doi: 10.1093/europace/euae045.

  PMID: 38340330 DERIVED

MeSH Terms

Conditions

Syncope; Syncope, Vasovagal

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases

Results Point of Contact

• Title: Paola Napoli, Clinical Project Manager
• Organization: BIOTRONIK Italy

paola.napoli@biotronik.com

3357369277

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 15, 2023
• Study Start: September 29, 2022
• Primary Completion: May 12, 2023
• Study Completion: May 12, 2023
• Last Updated: February 3, 2025
• Results First Posted: February 3, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

IT (2)