Prevention of Atrial Fibrillation by Optimized Overdrive... | NCT01912326

Studies
Prevention of Atrial Fibrillation by Optimized Overdrive Stimulation

NCT01912326

Sponsor

Abbott Medical Devices

Status

Completed

Last Update Posted

Oct 8, 2024Actual

Enrollment

249Actual

Phase

Not Applicable

Conditions

Bradycardia
Atrial Fibrillation

Interventions

Pacemaker Implantation

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2002

Primary Completion Date

Jan 2008Actual

Completion Date

Apr 2008Actual

First Submitted Date

Jul 26, 2013

First Submission Date that Met QC Criteria

Jul 26, 2013

First Posted Date

Jul 31, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 4, 2024

Last Update Posted Date

Oct 8, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Atrial Fibrillation is the most common Heart Rhythm Disorder requiring therapy.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

249Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Pacemaker Implantation	Device	Implantation of a dual chamber pacemaker	AF Suppression Off AF Suppression On

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction of AT/AF Burden in the pacemaker diagnostics		12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitätsklinikum Bonn AdöR		Bonn		53127	Germany

Condition Browse Module

MeSH Terms

ID	Term
D001919	Bradycardia
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided