Austria Study - Analysis of Difference Between Active and Passive Fixation Leads

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

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2007-05-31

Brief Summary

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

In this study the difference between screw in leads actively fixed in the septum and tined leads passively fixed in the apex concerning electrical parameters and implantation time will be evaluated. In addition the influence of the stimulation location by type of lead on QRS width, ejection fraction and NYHA class will be evaluated using and electrocardiogram and echocardiogram.

Related Clinical Trials

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

The Leadless AV Versus DDD Pacing Study

NCT05498376

Cardiac Pacemaker Arrhythmias, Cardiac Heart Diseases +1 more

RECRUITING PHASE4

His Pacing Feasibility and Cardiac Electrical Activation

NCT04739553

Pacing-Induced Cardiomyopathy AV Block Heart Failure

UNKNOWN NA

AF Stroke Substudy SL-ECG Versus 12lead ECG

NCT03715361

ECG Atrial Fibrillation ECG Hand-held Diagnostic Tool

COMPLETED

Left Bundle Branch Area Pacing Using Conventional Stylet-driven Pacemaker Leads for Cardiac Resynchronization Therapy

NCT05365568

Heart Failure with Reduced Ejection Fraction

ACTIVE_NOT_RECRUITING NA

Subcostal Temporary Extracardiac Pacing II Study

NCT04374929

Conduction Defect

COMPLETED NA

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.

Bradycardia Heart Block Sick Sinus Syndrome

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

NONE

Study Groups

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

Active fixation lead

Active fixation lead was implanted

Group Type EXPERIMENTAL

Flextend II, Fineline 2, Fineline Atrial J, Selute Picotip

Intervention Type DEVICE

Passive fixation lead

Passive fixation lead was implanted

Group Type ACTIVE_COMPARATOR

Flextend II, Fineline 2, Fineline Atrial J, Selute Picotip

Intervention Type DEVICE

Interventions

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

Flextend II, Fineline 2, Fineline Atrial J, Selute Picotip

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

Age \< 18 years, indication for pacemaker implantation according to current guidelines, written consent of the patient

Exclusion Criteria

Live expectancy \< 6 months, pregnancy or women without contraception in birth bearing age, inability or refusal to sign consent form, simultaneous participation in another clinical trial, contraindication for any procedure required during pacemaker implantation, patients who need other pacemaker systems including pacing leads than those required by the protocol, heart failure (LVEF \<35%, QRS-Width\>150ms), functional (rate dependent) bundle branch bloc

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No