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Trial record 2 of 63 for:    "sick sinus syndrome" OR "sinus node disease" OR "sinus node dysfunction"

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

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ClinicalTrials.gov Identifier: NCT02579889
Recruitment Status : Recruiting
First Posted : October 20, 2015
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sinus Node Disease Device: DDD+CLS Device: DDD(R) Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 1308 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical Benefits of the Closed Loop Stimulation in Sinus Node Disease - B3 Study
Study Start Date : September 2015
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. First event of Sustained Paroxysmal AF or Persistent AF or stroke or TIA, whichever comes first. [ Time Frame: three years ]

Secondary Outcome Measures :
  1. Sustained Paroxysmal AF (SPAF) [ Time Frame: Three years ]
    Assess the date of each events of SPAF occurred during the follow-up periods

  2. Persistent AF [ Time Frame: Three years ]
    Assess the date of each events of peristent AF occurred during the follow-up periods

  3. Permanent AF [ Time Frame: Three years ]
    Assess the date when AF is declared permanent

  4. Stroke/TIA [ Time Frame: Three years ]
    Assess the date of each events of stroke/TIA occurred during the follow-up periods

  5. 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

  6. All cause mortality [ Time Frame: Three years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02579889


Contacts
Contact: Alessio Gargaro alessio.gargaro@biotronik.com

Locations
Italy
Ospedali Riuniti di Ancona Recruiting
Torrette, Ancona, Italy, 60126
Principal Investigator: Alessandro Capucci         
Ospedale Generale Regionale "F. Miulli" Recruiting
Acquaviva Delle Fonti, Bari, Italy, 70021
Principal Investigator: Vincenzo Caccavo         
Ospedale "Bolognini" Recruiting
Seriate, Bergamo, Italy
Principal Investigator: Alessandro Locatelli         
Sub-Investigator: Bruno Casiraghi         
Ospedale Bolognini Recruiting
Seriate, Bergamo, Italy
Principal Investigator: Alessandro Locatelli         
Presidio Ospedaliero Ospedale Sant'Anna Recruiting
San Fermo della Battaglia, Como, Italy, 22020
Principal Investigator: Gianluca Botto         
Ospedale Civile SS. Annunziata Recruiting
Savigliano, Cuneo, Italy, 12038
Principal Investigator: Aldo Coppolino         
Ospedale F. Ferrari Recruiting
Casarano, Lecce, Italy
Principal Investigator: Donato Melissano         
Ospedale Maria SS Addolorata Recruiting
Eboli, Salerno, Italy, 84025
Principal Investigator: Angelo Catalano         
Ospedale Santa Maria della Stella Recruiting
Orvieto, Terni, Italy, 05018
Principal Investigator: Andrea Mazza         
Ospedale di Conegliano Recruiting
Conegliano, Treviso, Italy, 31015
Principal Investigator: Giuseppe Allocca         
Azienda Ospedaliera Policlinico Consorziale Recruiting
Bari, Italy
Principal Investigator: Domenico Carretta         
Ospedale Antonio Cardarelli Recruiting
Campobasso, Italy, 86100
Principal Investigator: Pierluigi Paolone         
Azienda Ospedaliera di Caserta Sant'Anna e San Sebastiano Recruiting
Caserta, Italy
Principal Investigator: Miguel Viscusi         
A.O.U. Policlinico Vittorio Emanuele Recruiting
Catania, Italy
Contact: Valeria Calvi       valcalcvi@unict.it   
Principal Investigator: Valeria Calvi         
Ospedale Santa Maria Nuova Not yet recruiting
Firenze, Italy, 50122
Principal Investigator: Marzia Giaccardi         
Ospedale Fabrizio Spaziani Recruiting
Frosinone, Italy
Principal Investigator: Luigi Carbonardi         
ASST Valle Olona - Ospedale Sant'Antonio Abate Recruiting
Gallarate, Italy
Principal Investigator: Ivan Caico         
ASST RHODENSE - Ospedale Guido Salvini Recruiting
Garbagnate, Italy
Principal Investigator: Fabio Locati         
Ospedale Ferdinando Veneziale Recruiting
Isernia, Italy, 86170
Principal Investigator: Bruno Castaldi         
Ospedale Vito Fazzi Recruiting
Lecce, Italy, 73100
Principal Investigator: Ennio Carmine Pisanò         
Nuovo Ospedale delle Apuane Recruiting
Massa, Italy, 54100
Principal Investigator: Giuseppe Arena         
Sub-Investigator: Vincenzo Borrello         
Centro Cardiologico Monzino Withdrawn
Milano, Italy
Ospedale V. Monaldi Recruiting
Napoli, Italy, 80131
Principal Investigator: Gerardo Nigro         
A.O.P. Federico II Recruiting
Napoli, Italy
Principal Investigator: Antonio Rapacciuolo         
A.O.U Maggiore della Carità di Novara Recruiting
Novara, Italy, 28100
Principal Investigator: Eraldo Occhetta         
Sub-Investigator: Gabriele Dell'Era         
Azienda Ospedaliera di Padova Recruiting
Padova, Italy
Principal Investigator: Emanuele Bertaglia         
Ospedale S. Maria della Misericordia Recruiting
Perugia, Italy
Principal Investigator: Gianluca Zingarini         
Nuovo Ospedale Santo Stefano Recruiting
Prato, Italy, 59100
Principal Investigator: Tiziana Giovannini         
Ospedale "Maria Paternò Arezzo" Recruiting
Ragusa, Italy, 97100
Principal Investigator: Antonino Nicosia         
Ospedale Infermi di Rimini Recruiting
Rimini, Italy, 47923
Principal Investigator: Davide Saporito         
Policlinico Umberto I Not yet recruiting
Roma, Italy, 00161
Principal Investigator: Raffaele Quaglione         
Policlinico Casilino Active, not recruiting
Roma, Italy, 00169
Fondazione Policlinico Universitario Agostino Gemelli Recruiting
Rom, Italy
Principal Investigator: Gemma Pelargonio         
Azienda Ospedaliera "S. Maria" di Terni Recruiting
Terni, Italy, 05100
Principal Investigator: Stefano Donzelli         
Ospedale di Treviso Recruiting
Treviso, Italy, 31100
Principal Investigator: Vittorio Calzolari         
Spain
Hospital General Universitario de Alicante Not yet recruiting
Alicante, Spain
Principal Investigator: Juan Gabriel Martinez         
Sponsors and Collaborators
Biotronik SE & Co. KG

Publications of Results:

Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT02579889     History of Changes
Other Study ID Numbers: BA104
First Posted: October 20, 2015    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: June 2018

Keywords provided by Biotronik SE & Co. KG:
Closed Loop Stimulation
Atrial Fibrillation
Stroke
Heart Failure
Pacemaker
ICD

Additional relevant MeSH terms:
Sick Sinus Syndrome
Arrhythmia, Sinus
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Heart Block
Pathologic Processes