NCT01912326

Brief Summary

Evaluation of dynamic Atrial Overdrive Stimulation using the AF Suppression Algorithm to prevent atrial tachyarrhythmias in patients with more than 2% Auto Mode Switch Episodes with optimized pacemaker programming. Hypothesis: Dynamic atrial Overdrive (AF Suppression) reduces AT/AF Burden by 30% as compared to programming DDDR-(60) without AF Suppression when all other parameters are optimized.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
249

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2002

Longer than P75 for not_applicable

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, 2002

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 31, 2013

Completed
Last Updated

October 8, 2024

Status Verified

October 1, 2024

Enrollment Period

5.5 years

First QC Date

July 26, 2013

Last Update Submit

October 4, 2024

Conditions

BradycardiaAtrial Fibrillation

Keywords

pacemakeratrial fibrillation

Outcome Measures

Primary Outcomes (1)

  • Reduction of AT/AF Burden in the pacemaker diagnostics

    12 months

Study Arms (2)

AF Suppression On

ACTIVE COMPARATOR

AF Suppression Algorithm On, optimized AF Pacemaker Programming

Device: Pacemaker Implantation

AF Suppression Off

ACTIVE COMPARATOR

AF Suppression programmed Off, Optimized Pacemaker Programming

Device: Pacemaker Implantation

Interventions

Pacemaker ImplantationDEVICE

Implantation of a dual chamber pacemaker

Also known as: Pacemaker St. Jude Medical Identity DR Model 5370 or 5376
AF Suppression OffAF Suppression On

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • indication for dual chamber pacemaker
  • documented paroxysmal or persistent Atrial Fibrillation
  • P-wave \>1.0 mV in Sinus Rhythm or sufficient detection of AFib
  • stable antyarrhythmic therapy
  • age \>= 19 years
  • written informed consent
  • implantation of a Identity DR 5370/5376 or later
  • bipolar atrial lead

You may not qualify if:

  • permanent AFib
  • reversible etiology of AFib
  • HYHA II or IV
  • Coronary Artery disease with stable angina pectoris
  • implanted ICD or planned implantation of a ICD
  • cardiac surgery within the last 6 months or planned within 12 months
  • live expectancy \< 12 months
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Bonn AdöR

Bonn, 53127, Germany

Location

MeSH Terms

Conditions

BradycardiaAtrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2013

First Posted

July 31, 2013

Study Start

July 1, 2002

Primary Completion

January 1, 2008

Study Completion

April 1, 2008

Last Updated

October 8, 2024

Record last verified: 2024-10

Locations

DE(1)