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 (BIO|Sync-HUTT)

January 9, 2025 updated by: Biotronik SE & Co. KG

BIO|Sync-HUTT: 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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The 2021 European Society of Cardiology guidelines recommend cardiac pacing in patients aged >40 years with tilt-induced asystolic reflex syncope (class I, level of evidence A). The recommendation relies on recent results from the multicentre, randomised, double-blinded, parallel-design BIOSync trial (NCT02324920). The BIOSync study provided evidence of benefit of dual chamber pacing in patients with tilt-induced reflex syncope and confirmed the role of Head-up Tilt Table (HUTT) test as a diagnostic method for cardiac pacing in reflex syncope. The Closed Loop Stimulation (CLS) is able to measure changes in intracardiac impedance during the systolic phase of each cardiac cycle which are strictly correlated to the increased heart rate and right ventricular contraction speed which are usually present during the pre-syncope phase of the reflex. It was hypothesized that an early onset of CLS pacing may be triggered by the compensatory increase in heart rate to counteract vasodilation and pressure drop during the pre-syncope phase of the reflex. The BIOSync study showed a 77% reduced risk of syncope in the DDD-CLS group as compared to pacing off. The design of the BIOSync study did not allow to assess the specific effect that CLS adds to dual-chamber pacing. Despite DDD-CLS pacing, 22% of patients had syncopal recurrence in 2 years. Further investigations are therefore needed in order to reduce this failure rate. Indeed, it is still unclear whether syncopal recurrences should be ascribed to dominant vasodilation or if the CLS programming/functioning needs optimization to more adequately sustain cardiac output during reflex in these specific cases.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

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
      • Bolzano, Italy, 39100
        • Ospedale di Bolzano - Azienda Sanitaria dell'Alto Adige
      • Napoli, Italy, 80131
        • Monaldi - AORN dei Colli - Università della Campania "Luigi Vanvitelli"

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion criteria

  • 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*.
  • Patients with a dual-chamber pacing system equipped with the CLS algorithm. * If needed, inclusion of other patients who did not participate in the BIOSync study will be considered to complete study cohort, provided that they have already a CLS pacemaker system and fulfill the same inclusion/exclusion criteria of the BIOSync study.

Exclusion criteria

  • 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).

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Heart Rate [Bpm] at Specific Time-points During Head-up Tilt Test (HUTT) Examination
Time Frame: From the start to the end of the HUTT examination, assessed up to 45 minutes
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
Time Frame: From the start to the end of the HUTT examination, assessed up to 45 minutes
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)
Time Frame: From the start to the end of the HUTT examination, assessed up to 45 minutes
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)
Time Frame: From the start to the end of the HUTT examination, assessed up to 45 minutes
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
Time Frame: From the start to the end of the HUTT examination, assessed up to 45 minutes
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
Time Frame: From the start to the end of the HUTT examination, assessed up to 45 minutes
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
Time Frame: From the start to the end of the HUTT examination, assessed up to 45 minutes
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
Time Frame: From the start to the end of the HUTT examination, assessed up to 45 minutes
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
Time Frame: From the start to the end of the HUTT examination, assessed up to 45 minutes
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]
Time Frame: From the start to the end of the HUTT examination, assessed up to 45 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
Time Frame: From the start to the end of the HUTT examination, assessed up to 45 minutes
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
Time Frame: From the start to the end of the HUTT examination, assessed up to 45 minutes
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

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biotronik SE & Co. KG

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 29, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 12, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 12, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 1, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 15, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BA117

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared on request to the corresponding author with permission of BIOTRONIK SE & Co. KG.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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