NCT00943046

Brief Summary

The objective of this study is to prove the safety and efficacy of the SIELLO pacemaker leads.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
164

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2009

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

July 1, 2009

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2009

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 21, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

July 26, 2019

Status Verified

May 1, 2017

Enrollment Period

4 months

First QC Date

July 14, 2009

Last Update Submit

July 24, 2019

Conditions

Cardiac Pacemaker Syndrome

Keywords

leadspacemakerefficacysafety

Outcome Measures

Primary Outcomes (3)

  • Complication free rate of all SIELLO leads

    3 month follow-up visits

  • Ventricular threshold of SIELLO T (passive fixation)

    3 month follow-up visits

  • Atrial threshold of SIELLO S (active fixation)

    3 month follow-up visits

Study Arms (1)

Siello pacemaker lead

EXPERIMENTAL

Patients with Siello Pacemaker lead

Device: Pacemaker therapy

Interventions

Pacemaker therapyDEVICE

Implantation of the SIELLO pacemaker leads

Siello pacemaker lead

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Meet the indications for pacemaker therapy
  • Understand the nature of the procedure
  • Give informed consent
  • Able to complete all testing required by the clinical protocol
  • Available for follow-up visits on a regular basis at the investigational site

You may not qualify if:

  • Meet none of the pacemaker indications
  • Meet one or more of the contraindications
  • Have a life expectancy of less than six months
  • Cardiac surgery in the next six months -Enrolled in another cardiac clinical investigation- Have other medical devices that may interact with the implanted pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allgemeines Krankenhaus Hamburg Altona

Hamburg, 22763, Germany

Location

Study Officials

  • Anselm Schaumann, Dr.

    n.k.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2009

First Posted

July 21, 2009

Study Start

July 1, 2009

Primary Completion

November 1, 2009

Study Completion

December 1, 2010

Last Updated

July 26, 2019

Record last verified: 2017-05

Locations

DE(1)