Clinical Benefits of the Closed Loop Stimulation in Sinus Node Disease

NCT ID: NCT02579889

Last Updated: 2024-01-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1390 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2023-12-31

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.

Conditions

Sinus Node Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

DDD+CLS

Intervention Type: DEVICE

Device will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON

Control group - CLS OFF

Device will be programmed in a dual-chamber DDD(R) pacing mode with the Closed Loop Stimulation (CLS) function OFF

Group Type: ACTIVE_COMPARATOR

DDD(R)

Intervention Type: DEVICE

Device will be programmed in a dual-chamber DDD(R) pacing mode with the Closed Loop Stimulation (CLS) function OFF

Interventions

DDD+CLS

Device will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON

Intervention Type: DEVICE

DDD(R)

Device will be programmed in a dual-chamber DDD(R) pacing mode with the Closed Loop Stimulation (CLS) function OFF

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotronik SE & Co. KG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Wuhan Asia Heart Hospital

Wuhan, Jinghan District, China

The 2nd Affiliated Hospital of Harbin Medical University

Harbin, Nangang District, China

Xuanwu Hospital Capital Medical University

Beijing, West City District, China

Semmelweis University Heart and Vascular Center

Budapest, , Hungary

Max Super Speciality Hospital

New Delhi, , India

Ospedali Riuniti di Ancona

Torrette, Ancona, Italy

Ospedale Generale Regionale "F. Miulli"

Acquaviva delle Fonti, Bari, Italy

Ospedale "Bolognini"

Seriate, Bergamo, Italy

Presidio Ospedaliero Ospedale Sant'Anna

San Fermo della Battaglia, Como, Italy

Ospedale Civile SS. Annunziata

Savigliano, Cuneo, Italy

Ospedale di Rho

Rho, Italia, Italy

Ospedale F. Ferrari

Casarano, Lecce, Italy

Ospedale Maria SS Addolorata

Eboli, Salerno, Italy

Ospedale Santa Maria della Stella

Orvieto, Terni, Italy

Ospedale di Conegliano

Conegliano, Treviso, Italy

Azienda Ospedaliera Policlinico Consorziale

Bari, , Italy

Ospedale Antonio Cardarelli

Campobasso, , Italy

Azienda Ospedaliera di Caserta Sant'Anna e San Sebastiano

Caserta, , Italy

A.O.U. Policlinico Vittorio Emanuele

Catania, , Italy

Ospedale Santa Maria Nuova

Florence, , Italy

Ospedale Fabrizio Spaziani

Frosinone, , Italy

ASST Valle Olona - Ospedale Sant'Antonio Abate

Gallarate, , Italy

ASST RHODENSE - Ospedale Guido Salvini

Garbagnate, , Italy

Ospedale Ferdinando Veneziale

Isernia, , Italy

Ospedale Vito Fazzi

Lecce, , Italy

Nuovo Ospedale delle Apuane

Massa, , Italy

Ospedale V. Monaldi

Napoli, , Italy

A.O.P. Federico II

Napoli, , Italy

A.O.U Maggiore della Carità di Novara

Novara, , Italy

Azienda Ospedaliera di Padova

Padua, , Italy

Ospedale S. Maria della Misericordia

Perugia, , Italy

Nuovo Ospedale Santo Stefano

Prato, , Italy

Ospedale "Maria Paternò Arezzo"

Ragusa, , Italy

Ospedale Infermi di Rimini

Rimini, , Italy

Policlinico Umberto I

Roma, , Italy

Policlinico Casilino

Roma, , Italy

Fondazione Policlinico Universitario Agostino Gemelli

Rome, , Italy

Azienda Ospedaliera "S. Maria" di Terni

Terni, , Italy

Ospedale di Treviso

Treviso, , Italy

Hospital Serdang

Kajang, , Malaysia

National Heart Center Singapore

Singapore, , Singapore

Tan Tock Seng Hospital

Singapore, , Singapore

Sejong General Hospital

Bucheon-si, , South Korea

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, , South Korea

Seul National University Bundang Hospital

Gyeonggi-do, , South Korea

Korea University Anam Hospital

Seoul, , South Korea

Seul National University Hospital

Seoul, , South Korea

Pusan National University Yangsan Hospital

Yangsan, , South Korea

Hospital General Universitario de Alicante

Alicante, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

China Medical University Hospital

Taichung, , Taiwan

National Cheng Kung University Hospital

Tainan City, , Taiwan

Chang Gung Memorial Hospital

Taipei, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Countries

China; Hungary; India; Italy; Malaysia; Singapore; South Korea; Spain; Taiwan

References

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Reference Type: RESULT

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Connolly SJ, Kerr CR, Gent M, Roberts RS, Yusuf S, Gillis AM, Sami MH, Talajic M, Tang AS, Klein GJ, Lau C, Newman DM. Effects of physiologic pacing versus ventricular pacing on the risk of stroke and death due to cardiovascular causes. Canadian Trial of Physiologic Pacing Investigators. N Engl J Med. 2000 May 11;342(19):1385-91. doi: 10.1056/NEJM200005113421902.

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Other Identifiers

BA104

Identifier Type: -

Identifier Source: org_study_id