NCT00215761

Brief Summary

Comparison of AF-Burden in patients with paroxysmal atrial fibrillation and the necessity of a Dual-Chamber-Pacemaker-Therapy either with a DDD\[R\]60-Stimulation or AF prevention pacing. All Patients were stratified according to their existing drug therapy, e.g. Beta-Blocker or ACE-Inhibitor.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
263

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

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

January 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

September 10, 2012

Status Verified

September 1, 2012

Enrollment Period

3.8 years

First QC Date

September 14, 2005

Last Update Submit

September 7, 2012

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillationPreventive stimulationPacemaker

Eligibility Criteria

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

Paroxysmal symptomatic atrial fibrillation with implemented dual-chamber pacemakers

You may qualify if:

  • Paroxysmal symptomatic atrial fibrillation
  • Implantation of a dual-chamber pacemaker because of generally accepted pacing indications
  • Symptomatic sinus bradycardia, sinus arrest, Tachy-Brady-Syndrome
  • Symptomatic sinuatrial block
  • Advanced AV-block (AV block II / III)
  • Binodal disease: Sick-sinus-syndrome and advanced AV-block
  • AV-Nodal-Ablation in combination with pacemaker therapy ( "Ablate \& Pace").
  • The implantation of a fully functional DDDR Selection 9000, Prevent AF, T 70 DR pacemaker (Vitatron) e.g. normal impedance, stimulation thresholds and sensing values) 2 - 4 months after implantation
  • Written informed consent of the patient
  • Age \> 18 years

You may not qualify if:

  • Chronic heart failure (NYHA III/IV)
  • Acute myocardial infarction \< 6 months
  • Hypertrophic obstructive cardiomyopathy
  • Symptomatic hypo- or hyperthyroidism
  • Instable angina pectoris
  • Cardiogenic shock
  • Patients with diabetes mellitus and recurrent hypoglycaemia
  • Pregnancy or breast feeding
  • Participation in a clinical trial within the last 30 days. Simultaneous participation in a registry (e.g. project AB1 of the AFNET) is permitted
  • Reduced life expectancy (\< 6 months)
  • Legal incapacity, or other circumstances which would prevent the patient from understanding the aim, nature or extent of the clinical trial
  • Evidence of an uncooperative attitude

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Cardiac Center

Hamburg, Hamburg, 20246, Germany

Location

Related Links

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Andreas Schuchert, Prof. Dr.

    University Cardiac Center, Hamburg, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 22, 2005

Study Start

January 1, 2005

Primary Completion

October 1, 2008

Study Completion

December 1, 2008

Last Updated

September 10, 2012

Record last verified: 2012-09

Locations

DE(1)