Avoid FFS - Use of the Atrial Pacemaker Lead 1699 With Very Short Tip Ring Spacing to Avoid Far Field Sensing

Atrial Fibrillation Clinical Trial

— Avoid FFS  

Official title:

Atriale Vorhofsonde 1699 Mit Sehr Kurzem Bipolabstand Zur Vermeidung Von Far Field Sensing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00512915
• Other study ID #: B84
• Status: Completed
• Phase: Phase 4
• Start date: December 2006
• Est. completion date: August 2008

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the possibility to program the shortest possible Post Ventricular Atrial Blanking Period (PVAB) and high sensitivity without getting inappropriate Mode Switch due to Far Field R-Wave sensing when using the new Tendril 1699T lead. Comparison with Tendril 1688T or 1388T with optimized Post Ventricular Atrial Blanking (PVAB).

Description:

Far-field R-wave sensing (FFS) in the atrial channel of dual chamber pacemakers is a relevant source for inappropriate Mode Switch from the DDD mode to the DDI or VDI mode. Inappropriate loss of atrioventricular synchrony due to false positive Mode Switch is hemodynamically disadvantageous, may induce atrial tachyarrhythmias, can lead to pacemaker syndrome, and impairs the reliability of pacemaker Holter data. The aim of the study is to determine whether the use of a new atrial screw in lead with ultra short tip-ring distance of 1.1 mm (Study Group) eliminates the need for individual adjustment of the postventricular atrial blanking period (PVAB) based on an additional test in the Control Group with standard leads.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: August 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Indication for dual chamber pacing

• Implantation of an Identity (ADX) DR or Victory or later pacemaker (St. Jude Medical)

• Bipolar atrial pacing electrode

• Age >= 18 years

Exclusion Criteria:

• Persistent / permanent Atrial Arrhythmia

• Pacemaker Revision

• Pregnancy

• Participation in another Study involving active implantable medical devices

• Unable to complete follow up

• Missing patient informed consent

• Cardiac surgery or myocardial infarction within the last 4 weeks

• Planned cardiac surgery within 3 months after enrollment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Bradycardia

Intervention

Device:
• pacemaker implantation
St. Jude Medical Dual Chamber Pacemaker model Identity (ADx) DR, Victory DR, or newer

Locations

Country	Name	City	State
Germany	Klinikum Coburg	Coburg
Germany	Klinik Fränkische Schweiz	Ebermannstadt
Germany	Kreisklinik Ebersberg	Ebersberg
Germany	Krankenhaus Waltershausen-Friedrichroda	Friedrichroda
Germany	Universitäres Herzzentrum Hamburg	Hamburg
Germany	Klinikum Memmingen	Memmingen
Germany	Kardiologische Praxis Dres. med. Bödigheimer / Mühling / Prof. Dr. med. Silber	München
Germany	Deutsches Herzzentrum Muenchen	Munich
Germany	Kreiskrankenhaus Ottweiler	Ottweiler
Germany	Universitätsklinikum Ulm	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of inappropriate mode switch (documented by stored EGM's) using the atrial lead Tendril 1699T with short post ventricular atrial blanking period (PVAB) compared to standard atrial lead (Tentril 1388 or 1688) with optimised PVAB		1 and 3 months post implantation
Secondary	Incidence of inappropriate mode switch in respect to lead position and ventricular stimulation frequency		1 and 3 months post implantation
Secondary	Atrial Flutter in stored EGM's		1 and 3 months post implantation
Secondary	2:1 lock in of Atrial Flutter		1 and 3 months post implantation