Optimal Sensing in Atrial Tachyarrhythmia's Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2014-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of the study is the comparison of two different leads in their capabilities to detect episodes and duration of paroxysmal atrial fibrillation (AF) and atrial tachyarrhythmia (AT), and the rejection of far field sensing of the far field R-wave (FFRW).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

SAFE Study - Septal Pacing for Atrial Fibrillation Suppression Evaluation

NCT00419640

Atrial Fibrillation

COMPLETED NA

Study Watch Atrial Fibrillation (AF) Detection Investigation

NCT04074434

Atrial Fibrillation

COMPLETED

APART: Prevention and Automatic Therapy of Atrial Arrhythmias in Patients With Paroxysmal Supraventricular Tachycardias

NCT00170274

Tachyarrhythmia

COMPLETED NA

Persistent Atrial Fibrillation (AF) APAC (Asia Pacific) Observational Study

NCT04244396

Persistent Atrial Fibrillation

TERMINATED

Arrhythmia Restart Prevention and RatE STabilization in Atrial Fibrillation

NCT00224341

Sick Sinus Syndrome Brady-Tachy Syndrome

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The aim of the study is the comparison of two different leads in their capabilities to detect episodes and duration of paroxysmal AF and AT and the rejection of far field sensing of the far field R-wave (FFRW). The study aims to evaluate the accuracy of the detection of atrial tachyarrhythmias (ATAs). An improved detection can potentially increase the accuracy of clinical treatment decisions, based on device derived data.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sick Sinus Syndrome Paroxysmal Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Optisense lead

Patients with an Accent pacemaker and an OptiSense atrial lead

Group Type ACTIVE_COMPARATOR

Accent Pacemaker

Intervention Type DEVICE

Implantation of pacemaker

Tendril lead

Patients with an Accent pacemaker and a Tendril atrial lead

Group Type ACTIVE_COMPARATOR

Accent Pacemaker

Intervention Type DEVICE

Implantation of pacemaker

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Accent Pacemaker

Implantation of pacemaker

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Accent DR RF 2212 Pacemaker OptiSense 1999 atrial lead

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with class I or II pacing indications for Sick Sinus Syndrome with suspected paroxysmal atrial tachyarrhythmias over the last 6 months
* Signed informed consent
* Age \>18 yrs

Exclusion Criteria

* Severe valvular heart disease (echocardiogram less than 6 months old)
* Angina Pectoris class ≥ III
* Congestive heart failure - NYHA class ≥ III
* Left Ventricular Ejection Fraction \< 35% (less than 6 months old)
* Hypertrophic Cardiomyopathy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No