NCT00161551

Brief Summary

The purpose of this study is to determine the incidence of atrial fibrillation and heart failure in patients with pacemaker therapy with different pacing modes (AAI, DDD, and a novel algorithm to minimize ventricular pacing).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
402

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2004

Longer than P75 for phase_4

Geographic Reach
1 country

5 active sites

Status
unknown

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

November 1, 2004

Completed
10 months 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
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

August 2, 2011

Status Verified

October 1, 2006

First QC Date

September 9, 2005

Last Update Submit

August 1, 2011

Conditions

Sick Sinus Syndrome

Keywords

Cardiac Pacing, artificialAtrial FibrillationHeart FailurePacemaker leadsPacing Mode

Outcome Measures

Primary Outcomes (1)

  • Primary objective is to assess how the pacing mode affects the incidence of atrial fibrillation (AF) in patients with sick sinus syndrome. Since there are no data on the safety of AAI pacing in patients with Wenckebach points < 120 bpm and accor

Secondary Outcomes (15)

  • Number of patients with atrial fibrillation or heart failure > NYHA II

  • AF burden

  • Symptomatic atrial fibrillation

  • Time period to first recurrence of AF

  • Number of patients without recurrence of AF

  • +10 more secondary outcomes

Interventions

Vitatron T70 DRDEVICE

Eligibility Criteria

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

You may qualify if:

  • Symptomatic sinus bradycardia, Sinusarrest
  • Symptomatic SA block
  • Bradycardia-Tachycardia-Syndrome
  • Binodal diseases

You may not qualify if:

  • st degree AV Block
  • nd degree AV block
  • rd degree AV block
  • Total right bundle branch block
  • Indication for biventricular stimulation
  • Inter atrial conduction delays (P-wave \> 150MS)
  • Permanent or therapy refractory Atrial Fibrillation
  • Heart Failure acc. NYHA III or IV
  • Myocardial Infarction less than 6 months before pacemaker implant
  • Hypertrophic obstructive cardiomyopathy
  • Symptomatic hypo- or hyperthyreosis
  • Cardiogenic shock
  • Pregnancy
  • Lactation period
  • Unstable angina pectoris
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Klinikum Coburg

Coburg, 96450, Germany

RECRUITING

Universitätskrankenhaus Eppendorf

Hamburg, 20251, Germany

RECRUITING

Kardiologische Gemeinschaftspraxis

Papenburg, 26871, Germany

RECRUITING

Kardiologische Praxis

Starnberg-Percha, 82319, Germany

RECRUITING

Sophien- und Hufelandklinikum GmbH

Weimar, 99425, Germany

RECRUITING

Related Publications (8)

  • Lamas GA, Orav EJ, Stambler BS, Ellenbogen KA, Sgarbossa EB, Huang SK, Marinchak RA, Estes NA 3rd, Mitchell GF, Lieberman EH, Mangione CM, Goldman L. Quality of life and clinical outcomes in elderly patients treated with ventricular pacing as compared with dual-chamber pacing. Pacemaker Selection in the Elderly Investigators. N Engl J Med. 1998 Apr 16;338(16):1097-104. doi: 10.1056/NEJM199804163381602.

    PMID: 9545357BACKGROUND

  • Lamas GA, Lee KL, Sweeney MO, Silverman R, Leon A, Yee R, Marinchak RA, Flaker G, Schron E, Orav EJ, Hellkamp AS, Greer S, McAnulty J, Ellenbogen K, Ehlert F, Freedman RA, Estes NA 3rd, Greenspon A, Goldman L; Mode Selection Trial in Sinus-Node Dysfunction. Ventricular pacing or dual-chamber pacing for sinus-node dysfunction. N Engl J Med. 2002 Jun 13;346(24):1854-62. doi: 10.1056/NEJMoa013040.

    PMID: 12063369BACKGROUND

  • 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

  • Nielsen JC, Kristensen L, Andersen HR, Mortensen PT, Pedersen OL, Pedersen AK. A randomized comparison of atrial and dual-chamber pacing in 177 consecutive patients with sick sinus syndrome: echocardiographic and clinical outcome. J Am Coll Cardiol. 2003 Aug 20;42(4):614-23. doi: 10.1016/s0735-1097(03)00757-5.

    PMID: 12932590BACKGROUND

  • Connolly SJ, Kerr CR, Gent M, Roberts RS, Yusuf S, Gillis AM, Sami MH, Talajic M, Tang AS, Klein GJ, Lau C, Newman DM. Effects of physiologic pacing versus ventricular pacing on the risk of stroke and death due to cardiovascular causes. Canadian Trial of Physiologic Pacing Investigators. N Engl J Med. 2000 May 11;342(19):1385-91. doi: 10.1056/NEJM200005113421902.

    PMID: 10805823BACKGROUND

  • Mattioli AV, Vivoli D, Mattioli G. Influence of pacing modalities on the incidence of atrial fibrillation in patients without prior atrial fibrillation. A prospective study. Eur Heart J. 1998 Feb;19(2):282-6. doi: 10.1053/euhj.1997.0616.

    PMID: 9519322BACKGROUND

  • Kerr CR, Connolly SJ, Abdollah H, Roberts RS, Gent M, Yusuf S, Gillis AM, Tang AS, Talajic M, Klein GJ, Newman DM. Canadian Trial of Physiological Pacing: Effects of physiological pacing during long-term follow-up. Circulation. 2004 Jan 27;109(3):357-62. doi: 10.1161/01.CIR.0000109490.72104.EE. Epub 2004 Jan 5.

    PMID: 14707022BACKGROUND

  • Wilkoff BL, Cook JR, Epstein AE, Greene HL, Hallstrom AP, Hsia H, Kutalek SP, Sharma A; Dual Chamber and VVI Implantable Defibrillator Trial Investigators. Dual-chamber pacing or ventricular backup pacing in patients with an implantable defibrillator: the Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial. JAMA. 2002 Dec 25;288(24):3115-23. doi: 10.1001/jama.288.24.3115.

    PMID: 12495391BACKGROUND

MeSH Terms

Conditions

Sick Sinus SyndromeAtrial FibrillationHeart Failure

Condition Hierarchy (Ancestors)

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

Study Officials

  • Volker Schibgilla, MD

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthias Reimers, Dipl. Documentalist

CONTACT

+49 21152930Matthias.reimers@vitatron.com

Steffen Gazarek, Dr., Engineer

CONTACT

+49 1729135662steffen.gazarek@vitatron.com

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

November 1, 2004

Study Completion

December 1, 2010

Last Updated

August 2, 2011

Record last verified: 2006-10

Locations

DE(5)