NCT00512915

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
204

participants targeted

Target at P50-P75 for phase_4 atrial-fibrillation

Timeline
Completed

Started Dec 2006

Shorter than P25 for phase_4 atrial-fibrillation

Geographic Reach
1 country

10 active sites

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

December 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 8, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

February 4, 2019

Status Verified

February 1, 2019

Enrollment Period

1.4 years

First QC Date

August 7, 2007

Last Update Submit

February 1, 2019

Conditions

Atrial FibrillationBradycardia

Keywords

Farfield SensingPacing leadPostventricular atrial blankingBradycardia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

1699T (Optisense)

ACTIVE COMPARATOR

Implantation of the Optisense Lead 1699T, programming of the shortest possible postventricular atrial blanking period (PVAB)

Device: pacemaker implantation

Standard lead

ACTIVE COMPARATOR

Implantation of a standard bipolar atrial pacing lead. Optimization of the postventricular atrial blanking period (PVAB) after implantation.

Device: pacemaker implantation

Interventions

pacemaker implantationDEVICE

St. Jude Medical Dual Chamber Pacemaker model Identity (ADx) DR, Victory DR, or newer

Also known as: Active Arm: 1699T Tendril Optisense lead, Standard lead: 1688T Tendril SDX, 1788T Tendril ST, 1888T Tendril ST OPTIM
1699T (Optisense)Standard lead

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Klinikum Coburg

Coburg, 96450, Germany

Location

Klinik Fränkische Schweiz

Ebermannstadt, 91320, Germany

Location

Kreisklinik Ebersberg

Ebersberg, 85560, Germany

Location

Krankenhaus Waltershausen-Friedrichroda

Friedrichroda, 99894, Germany

Location

Universitäres Herzzentrum Hamburg

Hamburg, 20246, Germany

Location

Klinikum Memmingen

Memmingen, 87700, Germany

Location

Deutsches Herzzentrum Muenchen

Munich, 80636, Germany

Location

Kardiologische Praxis Dres. med. Bödigheimer / Mühling / Prof. Dr. med. Silber

München, 80331, Germany

Location

Kreiskrankenhaus Ottweiler

Ottweiler, 66564, Germany

Location

Universitätsklinikum Ulm

Ulm, 89081, Germany

Location

Related Publications (1)

  • Kolb C, Nolker G, Lennerz C, Jetter H, Semmler V, Purner K, Gutleben KJ, Reents T, Lang K, Lotze U; AVOID-FFS Investigators. Use of an atrial lead with very short tip-to-ring spacing avoids oversensing of far-field R-wave. PLoS One. 2012;7(6):e38277. doi: 10.1371/journal.pone.0038277. Epub 2012 Jun 22.

    PMID: 22745661DERIVED

MeSH Terms

Conditions

Atrial FibrillationBradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Christof Kolb, MD

    Deutsches Herzzentrum Muenchen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 7, 2007

First Posted

August 8, 2007

Study Start

December 1, 2006

Primary Completion

May 1, 2008

Study Completion

August 1, 2008

Last Updated

February 4, 2019

Record last verified: 2019-02

Locations

DE(10)