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

Study Overview
=================
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.

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

Conditions
-----------------
Atrial Fibrillation, Bradycardia

Intervention / Treatment
-----------------
* Device: pacemaker implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1699T (Optisense)<br>Implantation of the Optisense Lead 1699T, programming of the shortest possible postventricular atrial blanking period (PVAB) | Device: pacemaker implantation<br>* St. Jude Medical Dual Chamber Pacemaker model Identity (ADx) DR, Victory DR, or newer<br>* Other names: Standard lead: 1688T Tendril SDX, 1788T Tendril ST, 1888T Tendril ST OPTIM;|
| Active Comparator: Standard lead<br>Implantation of a standard bipolar atrial pacing lead. Optimization of the postventricular atrial blanking period (PVAB) after implantation. | Device: pacemaker implantation<br>* St. Jude Medical Dual Chamber Pacemaker model Identity (ADx) DR, Victory DR, or newer<br>* Other names: Standard lead: 1688T Tendril SDX, 1788T Tendril ST, 1888T Tendril ST OPTIM;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 2:1 lock in of Atrial Flutter |  | 1 and 3 months post implantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Farfield Sensing, Pacing lead, Postventricular atrial blanking, Bradycardia