Clinical Benefits of the Closed Loop Stimulation in Sinus Node Disease
- Conditions
- Sinus Node Disease
- Interventions
- Device: DDD(R)Device: DDD+CLS
- Registration Number
- NCT02579889
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1390
- 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;
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group - CLS OFF DDD(R) Device will be programmed in a dual-chamber DDD(R) pacing mode with the Closed Loop Stimulation (CLS) function OFF Active group - CLS ON DDD+CLS Device will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON; Intervention: DDD+CLS
- Primary Outcome Measures
Name Time Method First event of Sustained Paroxysmal AF or Persistent AF or stroke or TIA, whichever comes first. three years
- Secondary Outcome Measures
Name Time Method Persistent AF Three years Assess the date of each events of peristent AF occurred during the follow-up periods
Sustained Paroxysmal AF (SPAF) Three years Assess the date of each events of SPAF occurred during the follow-up periods
Stroke/TIA Three years Assess the date of each events of stroke/TIA occurred during the follow-up periods
Worsening Heart failure Hospitalization (wHF-H) Three years Assess the date of each events of wHF-H occurred during the follow-up periods
Permanent AF Three years Assess the date when AF is declared permanent
All cause mortality Three years
Trial Locations
- Locations (54)
Nuovo Ospedale Santo Stefano
🇮🇹Prato, Italy
Sejong General Hospital
🇰🇷Bucheon, Korea, Republic of
Ospedale di Treviso
🇮🇹Treviso, Italy
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Seul National University Bundang Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
China Medical University Hospital
🇨🇳Taichung, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Ospedale "Bolognini"
🇮🇹Seriate, Bergamo, Italy
Ospedale Civile SS. Annunziata
🇮🇹Savigliano, Cuneo, Italy
Policlinico Umberto I
🇮🇹Roma, Italy
Policlinico Casilino
🇮🇹Roma, Italy
Chang Gung Memorial Hospital
🇨🇳Taipei, Taiwan
Ospedali Riuniti di Ancona
🇮🇹Torrette, Ancona, Italy
Ospedale Maria SS Addolorata
🇮🇹Eboli, Salerno, Italy
Wuhan Asia Heart Hospital
🇨🇳Wuhan, Jinghan District, China
ASST Valle Olona - Ospedale Sant'Antonio Abate
🇮🇹Gallarate, Italy
Ospedale Vito Fazzi
🇮🇹Lecce, Italy
Azienda Ospedaliera "S. Maria" di Terni
🇮🇹Terni, Italy
Ospedale Ferdinando Veneziale
🇮🇹Isernia, Italy
The 2nd Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Nangang District, China
Xuanwu Hospital Capital Medical University
🇨🇳Beijing, West City District, China
A.O.U. Policlinico Vittorio Emanuele
🇮🇹Catania, Italy
ASST RHODENSE - Ospedale Guido Salvini
🇮🇹Garbagnate, Italy
Ospedale Generale Regionale "F. Miulli"
🇮🇹Acquaviva Delle Fonti, Bari, Italy
Max Super Speciality Hospital
🇮🇳New Delhi, India
Ospedale di Conegliano
🇮🇹Conegliano, Treviso, Italy
Azienda Ospedaliera Policlinico Consorziale
🇮🇹Bari, Italy
Ospedale Fabrizio Spaziani
🇮🇹Frosinone, Italy
Azienda Ospedaliera di Padova
🇮🇹Padova, Italy
Ospedale S. Maria della Misericordia
🇮🇹Perugia, Italy
Fondazione Policlinico Universitario Agostino Gemelli
🇮🇹Rom, Italy
Presidio Ospedaliero Ospedale Sant'Anna
🇮🇹San Fermo della Battaglia, Como, Italy
Ospedale F. Ferrari
🇮🇹Casarano, Lecce, Italy
Ospedale Santa Maria della Stella
🇮🇹Orvieto, Terni, Italy
Hospital Serdang
🇲🇾Kajang, Malaysia
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Ospedale di Rho
🇮🇹Rho, Italia, Italy
Ospedale Antonio Cardarelli
🇮🇹Campobasso, Italy
Azienda Ospedaliera di Caserta Sant'Anna e San Sebastiano
🇮🇹Caserta, Italy
Ospedale Santa Maria Nuova
🇮🇹Firenze, Italy
Nuovo Ospedale delle Apuane
🇮🇹Massa, Italy
Ospedale V. Monaldi
🇮🇹Napoli, Italy
Semmelweis University Heart and Vascular Center
🇭🇺Budapest, Hungary
Seul National University Hospital
🇰🇷Seoul, Korea, Republic of
Soon Chun Hyang University Hospital Bucheon
🇰🇷Bucheon, Korea, Republic of
National Heart Center Singapore
🇸🇬Singapore, Singapore
A.O.U Maggiore della Carità di Novara
🇮🇹Novara, Italy
Ospedale "Maria Paternò Arezzo"
🇮🇹Ragusa, Italy
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
Tan Tock Seng Hospital
🇸🇬Singapore, Singapore
A.O.P. Federico II
🇮🇹Napoli, Italy
Ospedale Infermi di Rimini
🇮🇹Rimini, Italy
Pusan National University Yangsan Hospital
🇰🇷Yangsan, Korea, Republic of
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan