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Clinical Benefits of the Closed Loop Stimulation in Sinus Node Disease

NCT02579889 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1390

Last updated 2024-01-18

No results posted yet for this study

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.

Conditions

  • Sinus Node Disease

Interventions

DEVICE

DDD+CLS

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

DEVICE

DDD(R)

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

Sponsors & Collaborators

  • Biotronik SE & Co. KG

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2023-03-31
Completion
2023-12-31

Countries

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

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02579889 on ClinicalTrials.gov