Benefit of Dual-chamber Pacing With Closed Loop Stimulation (CLS) in Tilt-induced Cardioinhibitory Reflex Syncope (BIOSync CLS)

October 21, 2021 updated by: Biotronik SE & Co. KG

Benefit of Dual-chamber Pacing With Closed Loop Stimulation (CLS) in Tilt-induced Cardioinhibitory Reflex Syncope. A Randomized Double-blind Parallel Trial.

The purpose of this study is to assess whether the Closed Loop Stimulation (CLS) in addition to the DDD pacing is effective in reducing syncopal recurrences. The study hypothesis is that DDD pacing with CLS stimulation is able to prevent syncopal recurrences completely or partially by transforming syncope in pre-syncope.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

128

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

  • Canada
      • Sherbrooke, Canada
        • CHUS Sherbrooke
  • France
      • Aix-en-Provence, France
        • Pais d'Aix
      • Marseille, France
        • Hopital De La Timone
      • Toulouse, France
        • Clinique Pasteur
  • Italy
      • Bari, Italy
        • Policlinico Consorziale
      • Bolzano, Italy
        • Ospedale Centrale di Bolzano
      • Catanzaro, Italy
        • A.O. Pugliese-Ciaccio
      • Genova, Italy
        • Ospedale San Martino
      • Milano, Italy
        • Azienda Ospedaliera Niguarda Ca' Granda
      • Napoli, Italy
        • Azienda Ospedaliera Universitaria Federico II
      • Napoli, Italy
        • A.O. Dei Colli - Monaldi - University of Campania "Luigi Vanvitelli"
      • Orbassano, Italy
        • A.O.U. San Luigi Gonzaga
      • Parma, Italy
        • AO di Parma
      • Reggio Emilia, Italy
        • Arcispedale Santa Maria Nuova
      • Roma, Italy
        • Policlinico Casilino
    • BA
      • Tricase, BA, Italy
        • Azienda Ospedaliera Pia Fondazione di Culto e Religione Cardinale G. Panico
  • Netherlands
      • Amsterdam, Netherlands
        • AMC Academic Medical Center
      • Arnhem, Netherlands
        • Rijnstate Ziekenjuis
      • Heerlen, Netherlands
        • Zuyderland Medisch Centrum
  • Portugal
      • Lisboa, Portugal
        • Santa Marta
  • Spain
      • Barcelona, Spain
        • Hospital de Bellvitge
      • Barcelona, Spain
        • Hospital Universitario Vall d'Hebron
      • Santa Cruz, Spain
        • Hospital Universitario Nuestra Señora de la Candelaria
      • Sevilla, Spain
        • Hospital Virgen del Rocío

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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients affected by clinical diagnosis of reflex syncope who meet all the following criteria:

  • age >=40 years
  • significant limitation of social and working life due to unpredictable or frequent syncope recurrences, ≥2 within the last year.
  • type 2B cardio-inhibitory response to TT (according to the VASIS classification).
  • Alternative therapies have failed or were not feasible.
  • exclusion of other possible competitive causes of syncope.

Exclusion Criteria:

- Any other indication to IPG, implantable defibrillator (ICD), cardiac resynchronization therapy (CRT), according to current guidelines

Any cardiac dysfunctions possibly leading to loss of consciousness:

  • overt heart failure;
  • ejection fraction (LVEF) <40% (Echo-assessed within 3-month prior to study participation);
  • 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;
  • bundle-branch block;
  • rapid paroxysmal supraventricular tachycardia or ventricular tachycardia;
  • preexcited QRS complexes;
  • prolonged QT interval;
  • Brugada syndrome;
  • arrhythmogenic right ventricular cardiomyopathy
  • Symptomatic orthostatic hypotension diagnosed by standing BP measurement;
  • Nonsyncopal loss of consciousness (eg, epilepsy, psychiatric, metabolic, drop-attack, cerebral transient ischemic attack, intoxication, cataplexy).
  • Symptomatic cardioinhibitory carotid sinus hypersensitivity.

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: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DDD+CLS
The pacemaker will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON.
Device: DDD-CLS
Placebo Comparator: ODO
The pacemaker will be programmed in ODO mode.
Device: ODO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patients With Recurrence of Syncopal Episode
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Patients With Recurrence of Pre-syncope or Syncope
Time Frame: 24 months
24 months

Collaborators and Investigators

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

Sponsor

Biotronik SE & Co. KG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 1, 2015

Primary Completion (Actual)

April 1, 2020

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

December 19, 2014

First Submitted That Met QC Criteria

December 19, 2014

First Posted (Estimate)

December 24, 2014

Study Record Updates

Last Update Posted (Actual)

November 17, 2021

Last Update Submitted That Met QC Criteria

October 21, 2021

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BA103

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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