Clinical Investigation Plan for the AVOPT Data Collection Clinical 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

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-02-28

Brief Summary

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

The purpose of this study is to collect clinical data for the development and evaluation of a new device feature for automatic AV-delay (AVD) optimization.

Related Clinical Trials

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

Optimal Programming to Improve Mechanical Indices, Symptoms and Exercise in Cardiac Resynchronization Therapy.

NCT00489177

Heart Failure

COMPLETED PHASE4

Optimal Anti-tachycardia Therapy in Implantable Cardioverter-defibrillator (ICD) Patients Without Pacing Indications

NCT00729703

Tachycardia

COMPLETED PHASE4

Evaluation of Automatic Threshold Algorithms

NCT02097290

Heart Failure

COMPLETED NA

Comparison of Right Ventricular Septal and Right Ventricular Apical Pacing in Patients Receiving a CRT-D Device

NCT00833352

Systolic Heart Failure Ventricular Tachycardia Ventricular Fibrillation

COMPLETED NA

Efficacy of the ATP Switch Automatic Programming in Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) Implanted Patients

NCT01169246

Ventricular Arrythmias

TERMINATED

Detailed Description

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

Conditions

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

Cardiac Pacemaker, Artificial

Study Design

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

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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

AVOPT Patient

Group Type EXPERIMENTAL

Pacemaker

Intervention Type DEVICE

Interventions

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

Pacemaker

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

* Patients implanted with an Evia DR(T) or Entovis DR(T) pacemaker
* Possessing 1st or 3rd degree AV block
* Implanted with Biotronik bipolar RA and RV leads
* Implantation date should be at least 4 months prior to this study

Exclusion Criteria

* Patient is a minor (18 years old or younger)
* Patient is pregnant or breast-feeding
* Patient does not have the legal capacity to provide consent
* Patient has Mobitz type I or Mobitz type II heart block
* Patient has persistent supraventricular tachycardia (including atrial fibrillation) or ectopic beats.
* Patient is participating in other clinical studies during the clinical study
* Patient is strictly pacemaker dependent (physician discretion)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes