NCT00161538

Brief Summary

The purpose of this study is to determine which of 4 lead positions is most effective for pacemaker patients with Sick Sinus Syndrome in order to avoid development of atrial fibrillation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
456

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2000

Longer than P75 for phase_4

Geographic Reach
1 country

12 active sites

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, 2000

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

October 20, 2006

Status Verified

October 1, 2006

First QC Date

September 9, 2005

Last Update Submit

October 19, 2006

Conditions

Sick Sinus Syndrome

Keywords

Cardiac Pacing, artificialAtrial fibrillationPacemaker leadsLead positions

Outcome Measures

Primary Outcomes (2)

  • The incidence of AF is determined via memory of the pacemaker, which is saved at every follow-up visit at 1 and 10 days after implant and further on at 3, 6, 12, 18 and 24 months after implant.

  • 24-Hour ECG and treadmill exercise as well as echocardiography shall be performed before implant and 6, 12 and 24 months after implant

Secondary Outcomes (2)

  • Treadmill exercise test as well as echocardiography shall be performed before implant and 6, 12 and 24 month after implant.

  • Quality of Life questionnaires are obtained before implant and 12 and 24 months after implants

Interventions

Pacing leads to be implanted according randomization.DEVICE
Selection 9000 prevent AF an Diagnose AFDEVICE

Eligibility Criteria

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

You may qualify if:

  • Sick Sinus Syndrome
  • Symptomatic sinus bradycardia
  • Symptomatic SA block
  • Bradycardia-Tachycardia-Syndrom
  • Binodal diseases, Sinus Node Syndrome and high degree AV-Block
  • In case of antiarrhythmic drug therapy: patient must be on a stable dose for at least 3 months before enrollment

You may not qualify if:

  • Permanent atrial tachycardia that cannot be transferred into sinus rhythm by drugs or electric cardioversion
  • Decompensated heart failure
  • Dilatative cardiomyopathy with an ejection fraction \< 35%
  • Hypertrophic obstructive cardiomyopathy
  • Symptomatic hypo- or hyperthyreosis
  • Myocardial infarction less than 6 months ago
  • Planned cardiac surgery intervention
  • Pregnant woman
  • Patients under 18 years of age
  • Patients involved in other studies
  • Patients, already implanted with other (cardiac) leads
  • Patients with reduced expectancy of life due to other diseases
  • Patients who are not able to agree in participation of the study
  • Patients, who cannot attend follow-up visits due to their place of residence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Helios-Klinikum Aue

Aue, 08280, Germany

Location

Klinikum Coburg

Coburg, 96450, Germany

Location

Ambulantes Herz-Zentrum Dresden

Dresden, 01099, Germany

Location

Werner-Forssmann-Krankenhaus GmbH

Eberswalde, 16225, Germany

Location

Klinikum der Joh.-Wolfgang-Goethe-Universität

Frankfurt, 60596, Germany

Location

Städtisches Krankenhaus Friedrichshafen

Friedrichshafen, 88048, Germany

Location

Universitätskrankenhaus Eppendorf

Hamburg, 20251, Germany

Location

Evang. Krankenhaus

Holzminden, 37603, Germany

Location

Klinikum Ingolstadt

Ingolstadt, 85049, Germany

Location

Evangelisches Krankenhaus Kalk GmbH

Köhl, 51103, Germany

Location

Kreiskrankenhaus Leer

Leer, 26789, Germany

Location

Krankenhaus Maria Hilf

Mönchengladbach, 41063, Germany

Location

Related Publications (3)

  • Andersen HR, Nielsen JC, Thomsen PE, Thuesen L, Mortensen PT, Vesterlund T, Pedersen AK. Long-term follow-up of patients from a randomised trial of atrial versus ventricular pacing for sick-sinus syndrome. Lancet. 1997 Oct 25;350(9086):1210-6. doi: 10.1016/S0140-6736(97)03425-9.

    PMID: 9652562BACKGROUND

  • Rosenqvist M, Brandt J, Schuller H. Long-term pacing in sinus node disease: effects of stimulation mode on cardiovascular morbidity and mortality. Am Heart J. 1988 Jul;116(1 Pt 1):16-22. doi: 10.1016/0002-8703(88)90244-x.

    PMID: 3394616BACKGROUND

  • Prakash A, Saksena S, Hill M, Krol RB, Munsif AN, Giorgberidze I, Mathew P, Mehra R. Acute effects of dual-site right atrial pacing in patients with spontaneous and inducible atrial flutter and fibrillation. J Am Coll Cardiol. 1997 Apr;29(5):1007-14. doi: 10.1016/s0735-1097(97)00043-0.

    PMID: 9120152BACKGROUND

MeSH Terms

Conditions

Sick Sinus SyndromeAtrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmia, SinusArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesHeart BlockCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Stefan G. Spitzer, MD

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 12, 2005

Study Start

July 1, 2000

Study Completion

June 1, 2006

Last Updated

October 20, 2006

Record last verified: 2006-10

Locations

DE(12)