Clinical Benefits of the Closed Loop Stimulation in Sinus Node Disease (B3)

January 15, 2024 updated by: Biotronik SE & Co. KG

Clinical Benefits of the Closed Loop Stimulation in Sinus Node Disease - B3 Study

The study is designed as a multi-center, international, prospective, parallel, randomized, single blinded trial comparing the time to first primary endpoint event (Sustained Paroxysmal AF/Persistent AF or stroke/TIA) occurrence in a follow up period of 3 years, between Closed Loop Stimulation (CLS) ON versus OFF, on top of a DDD pacing in patients with pacemaker or ICD indication who require dual-chamber pacing due to sinus node disease (SND), with or without atrioventricular (AV) block.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The benefits of rate-responsiveness on top of dual-chamber pacing still need to be definitively assessed in Sinus Node Dysfunction (SND). Although many rate responsive (RR) sensors have been developed, no large clinical trials evaluated their benefits in terms of clinical endpoints such as clinically relevant atrial fibrillation (AF) and stroke. Electromechanical sensors (piezoelectric accelerometers) have been widely used for their simplicity and overall reliability. However there is some evidence indicating the Closed Loop Stimulation as one of the more efficient and physiological sensors.

Two randomized clinical studies have been conducted so far, showing that in the Brady-Tachy Syndrome the CLS algorithm was associated with a significantly lower overall atrial arrhythmia burden as compared both with a DDDR mode based on a standard accelerometric sensor and an atrial overdrive approach.

Both studies yielded consistent results, albeit with a parallel and intraindividual comparison designs, respectively. The atrial arrhythmic burden is an important but surrogate endpoint, not necessarily related to long-term clinical outcome. The CLS effects on AF (if any) should be investigated in terms of time to first new onset of clinically relevant AF.

In the light of these considerations, it appears interesting to run a large randomized study coherently collecting data on the overall clinical benefit of CLS, primarily in terms of AF and stroke, in a population indicated for pacemaker or ICD and needing dual-chamber pacing due to SND.

Study Type

Interventional

Enrollment (Actual)

1390

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

  • China
    • Jinghan District
      • Wuhan, Jinghan District, China, 430022
        • Wuhan Asia Heart Hospital
    • Nangang District
      • Harbin, Nangang District, China
        • The 2nd Affiliated Hospital of Harbin Medical University
    • West City District
      • Beijing, West City District, China, 100053
        • Xuanwu Hospital Capital Medical University
  • Hungary
      • Budapest, Hungary, 1122
        • Semmelweis University Heart and Vascular Center
  • India
      • New Delhi, India, 110017
        • Max Super Speciality Hospital
  • Italy
      • Bari, Italy
        • Azienda Ospedaliera Policlinico Consorziale
      • Campobasso, Italy, 86100
        • Ospedale Antonio Cardarelli
      • Caserta, Italy
        • Azienda Ospedaliera di Caserta Sant'Anna e San Sebastiano
      • Catania, Italy
        • A.O.U. Policlinico Vittorio Emanuele
      • Firenze, Italy, 50122
        • Ospedale Santa Maria Nuova
      • Frosinone, Italy
        • Ospedale Fabrizio Spaziani
      • Gallarate, Italy
        • ASST Valle Olona - Ospedale Sant'Antonio Abate
      • Garbagnate, Italy
        • ASST RHODENSE - Ospedale Guido Salvini
      • Isernia, Italy, 86170
        • Ospedale Ferdinando Veneziale
      • Lecce, Italy, 73100
        • Ospedale Vito Fazzi
      • Massa, Italy, 54100
        • Nuovo Ospedale delle Apuane
      • Napoli, Italy, 80131
        • Ospedale V. Monaldi
      • Napoli, Italy
        • A.O.P. Federico II
      • Novara, Italy, 28100
        • A.O.U Maggiore della Carità di Novara
      • Padova, Italy
        • Azienda Ospedaliera di Padova
      • Perugia, Italy
        • Ospedale S. Maria Della Misericordia
      • Prato, Italy, 59100
        • Nuovo Ospedale Santo Stefano
      • Ragusa, Italy, 97100
        • Ospedale "Maria Paternò Arezzo"
      • Rimini, Italy, 47923
        • Ospedale Infermi di Rimini
      • Rom, Italy
        • Fondazione Policlinico Universitario Agostino Gemelli
      • Roma, Italy, 00161
        • Policlinico Umberto I
      • Roma, Italy, 00169
        • Policlinico Casilino
      • Terni, Italy, 05100
        • Azienda Ospedaliera "S. Maria" di Terni
      • Treviso, Italy, 31100
        • Ospedale di Treviso
    • Ancona
      • Torrette, Ancona, Italy, 60126
        • Ospedali Riuniti di Ancona
    • Bari
      • Acquaviva Delle Fonti, Bari, Italy, 70021
        • Ospedale Generale Regionale "F. Miulli"
    • Bergamo
      • Seriate, Bergamo, Italy
        • Ospedale "Bolognini"
    • Como
      • San Fermo della Battaglia, Como, Italy, 22020
        • Presidio Ospedaliero Ospedale Sant'Anna
    • Cuneo
      • Savigliano, Cuneo, Italy, 12038
        • Ospedale Civile SS. Annunziata
    • Italia
      • Rho, Italia, Italy, 20017
        • Ospedale di Rho
    • Lecce
      • Casarano, Lecce, Italy
        • Ospedale F. Ferrari
    • Salerno
      • Eboli, Salerno, Italy, 84025
        • Ospedale Maria SS Addolorata
    • Terni
      • Orvieto, Terni, Italy, 05018
        • Ospedale Santa Maria della Stella
    • Treviso
      • Conegliano, Treviso, Italy, 31015
        • Ospedale di Conegliano
  • Korea, Republic of
      • Bucheon, Korea, Republic of
        • Soon Chun Hyang University Hospital Bucheon
      • Bucheon, Korea, Republic of, 14154
        • Sejong General Hospital
      • Gyeonggi-do, Korea, Republic of
        • Seul National University Bundang Hospital
      • Seoul, Korea, Republic of, 02841
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 03080
        • Seul National University Hospital
      • Yangsan, Korea, Republic of
        • Pusan National University Yangsan Hospital
  • Malaysia
      • Kajang, Malaysia, 43000
        • Hospital Serdang
  • Singapore
      • Singapore, Singapore, 308433
        • Tan Tock Seng Hospital
      • Singapore, Singapore, 169609
        • National Heart Center Singapore
  • Spain
      • Alicante, Spain
        • Hospital General Universitario de Alicante
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
  • Taiwan
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Tainan, Taiwan
        • National Cheng Kung University Hospital
      • Taipei, Taiwan
        • National Taiwan University Hospital
      • Taipei, Taiwan
        • Chang Gung Memorial Hospital

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

Description

Inclusion Criteria:

  • Patients with Class I or II recommendations for permanent pacing due to SND, with or without AV block according to the current guidelines;
  • Patients for whom dual-chamber pacing is indicated or preferred;
  • Patients with an optimized and stable antiarrhythmic medical therapy at the time of enrolment;
  • Closed Loop Stimulation function was not previously activated;
  • No stroke events from implant;
  • Patient implanted for the first time;

Exclusion Criteria:

  • Permanent AF (PermAF)
  • NYHA Class IV Heart Failure
  • Stage V kidney dysfunction
  • Any indication to Cardiac Resynchronization Therapy (CRT)
  • Life expectancy < 1
  • Minors
  • Pregnant or breast-feeding patients
  • Participation in another interventional trial
  • Atrial fibrillation ablation (left pulmonary veins) or other cardiac surgery < 3 m

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active group - CLS ON
Device will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON; Intervention: DDD+CLS
Device: DDD+CLS
Device will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON
Active Comparator: Control group - CLS OFF
Device will be programmed in a dual-chamber DDD(R) pacing mode with the Closed Loop Stimulation (CLS) function OFF
Device: DDD(R)
Device will be programmed in a dual-chamber DDD(R) pacing mode with the Closed Loop Stimulation (CLS) function OFF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
First event of Sustained Paroxysmal AF or Persistent AF or stroke or TIA, whichever comes first.
Time Frame: three years
three years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained Paroxysmal AF (SPAF)
Time Frame: Three years
Assess the date of each events of SPAF occurred during the follow-up periods
Three years
Persistent AF
Time Frame: Three years
Assess the date of each events of peristent AF occurred during the follow-up periods
Three years
Permanent AF
Time Frame: Three years
Assess the date when AF is declared permanent
Three years
Stroke/TIA
Time Frame: Three years
Assess the date of each events of stroke/TIA occurred during the follow-up periods
Three years
Worsening Heart failure Hospitalization (wHF-H)
Time Frame: Three years
Assess the date of each events of wHF-H occurred during the follow-up periods
Three years
All cause mortality
Time Frame: Three years
Three years

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

September 1, 2015

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

October 16, 2015

First Submitted That Met QC Criteria

October 16, 2015

First Posted (Estimated)

October 20, 2015

Study Record Updates

Last Update Posted (Actual)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 15, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BA104

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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