NCT01000532

Brief Summary

This investigation is designed to demonstrate the clinical efficacy and safety of the low-dose drug of the SIELLO leads in comparison to the non-steroid BPPU leads in a clinical investigation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 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

October 1, 2009

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

November 16, 2011

Status Verified

November 1, 2011

Enrollment Period

11 months

First QC Date

October 21, 2009

Last Update Submit

November 15, 2011

Conditions

Arrhythmias, Cardiac

Keywords

steroid, leads, threshold, pacemaker

Study Arms (1)

Pacemaker therapy

Device: SIELLO JT/TDevice: Pacemaker therapyDevice: BPPU JT/T

Interventions

SIELLO JT/TDEVICE

Implantation of SIELLO and BPPU pacemaker leads

Also known as: BPPU JT/T
Pacemaker therapy
Pacemaker therapyDEVICE

Pacemaker therapy

Pacemaker therapy
BPPU JT/TDEVICE

Implantation of SIELLO and BPPU pacemaker leads

Pacemaker therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with standard pacemaker indication who are refered to the hospital.

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)

Semmelweis University

Budapest, Hungary

Location

Related Publications (1)

  • Kutyifa V, Zima E, Molnar L, Kuehne C, Theiss S, Herrmann G, Geller L, Merkely B. Direct comparison of steroid and non-steroid eluting small surface pacing leads: randomized, multicenter clinical trial. Cardiol J. 2013;20(4):431-8. doi: 10.5603/CJ.2013.0103.

    PMID: 23913463DERIVED

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Béla Merkely, Professor

    Semmelweis University Heart Center, Budapest, Hungary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2009

First Posted

October 23, 2009

Study Start

October 1, 2009

Primary Completion

September 1, 2010

Study Completion

February 1, 2011

Last Updated

November 16, 2011

Record last verified: 2011-11

Locations

HU(1)