NCT00180557

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2003

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

March 17, 2015

Status Verified

December 1, 2007

First QC Date

September 15, 2005

Last Update Submit

March 10, 2015

Conditions

BradycardiaHeart BlockSick Sinus Syndrome

Outcome Measures

Primary Outcomes (3)

  • QRS width

  • Ejection fraction

  • NYHA class

Study Arms (2)

Active fixation lead

EXPERIMENTAL

Active fixation lead was implanted

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

Passive fixation lead

ACTIVE COMPARATOR

Passive fixation lead was implanted

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

Interventions

Flextend II, Fineline 2, Fineline Atrial J, Selute PicotipDEVICE
Active fixation leadPassive fixation lead

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Krankenhaus der barmherzigen Schwestern

Ried im Innkreis, Austria

Location

MeSH Terms

Conditions

BradycardiaHeart BlockSick Sinus Syndrome

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCardiac Conduction System DiseaseArrhythmia, Sinus

Study Officials

  • C Nimeth, MD

    Krankenhaus der barmherzigen Schwestern Ried im Innkreis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 16, 2005

Study Start

September 1, 2003

Study Completion

May 1, 2007

Last Updated

March 17, 2015

Record last verified: 2007-12

Locations

AU(1)