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

Phase 4

Completed

• Conditions: Bradycardia; Atrial Fibrillation
• Interventions: Device: pacemaker implantation

• Registration Number: NCT00512915
• Lead Sponsor: Abbott Medical Devices

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-08-07
• Study First Submitted QC: 2007-08-07
• Study First Posted: 2007-08-08
• Primary Completion: 2008-05
• Study Completion: 2008-08
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1699T (Optisense)	pacemaker implantation	Implantation of the Optisense Lead 1699T, programming of the shortest possible postventricular atrial blanking period (PVAB)
Standard lead	pacemaker implantation	Implantation of a standard bipolar atrial pacing lead. Optimization of the postventricular atrial blanking period (PVAB) after implantation.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
2:1 lock in of Atrial Flutter	1 and 3 months post implantation
Incidence of inappropriate mode switch in respect to lead position and ventricular stimulation frequency	1 and 3 months post implantation
Atrial Flutter in stored EGM's	1 and 3 months post implantation

Trial Locations

Locations (10)

Klinikum Coburg; 🇩🇪 Coburg, Germany

Kreisklinik Ebersberg; 🇩🇪 Ebersberg, Germany

Universitäres Herzzentrum Hamburg; 🇩🇪 Hamburg, Germany

Klinikum Memmingen; 🇩🇪 Memmingen, Germany

Kardiologische Praxis Dres. med. Bödigheimer / Mühling / Prof. Dr. med. Silber; 🇩🇪 München, Germany

Kreiskrankenhaus Ottweiler; 🇩🇪 Ottweiler, Germany

Universitätsklinikum Ulm; 🇩🇪 Ulm, Germany

Deutsches Herzzentrum Muenchen; 🇩🇪 Munich, Germany

Krankenhaus Waltershausen-Friedrichroda; 🇩🇪 Friedrichroda, Germany

Klinik Fränkische Schweiz; 🇩🇪 Ebermannstadt, Germany