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Atrial FibrillationPhase 4Avoid FFSNCT00512915

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

A Phase 4 study testing pacemaker implantation in people with Atrial Fibrillation and Bradycardia, run by Abbott Medical Devices at 10 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation, Bradycardia
What is being tested?
pacemaker implantation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
204 participants
Where
10 sitesGermany
Study dates
Dec 2006to Aug 2008
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Germany10 sites

  • Klinikum Coburg

    Coburg, 96450

  • Klinik Fränkische Schweiz

    Ebermannstadt, 91320

  • Kreisklinik Ebersberg

    Ebersberg, 85560

  • Krankenhaus Waltershausen-Friedrichroda

    Friedrichroda, 99894

  • Universitäres Herzzentrum Hamburg

    Hamburg, 20246

  • Klinikum Memmingen

    Memmingen, 87700

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

    München, 80331

  • Deutsches Herzzentrum Muenchen

    Munich, 80636

  • Kreiskrankenhaus Ottweiler

    Ottweiler, 66564

  • Universitätsklinikum Ulm

    Ulm, 89081

Other trials in Germany

About this study

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

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).

Read the 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.

Being tested
pacemaker implantation
Keywords
Farfield Sensing, Pacing lead, Postventricular atrial blanking, Bradycardia
Medical subject headings
Atrial Fibrillation, Bradycardia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pacemaker implantationDevice

    Also called Active Arm: 1699T Tendril Optisense lead, Standard lead: 1688T Tendril SDX, 1788T Tendril ST, 1888T Tendril ST OPTIM

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

Study groups in NCT00512915
Study groupRoleWhat they receive
1699T (Optisense)Active comparatorImplantation of the Optisense Lead 1699T, programming of the shortest possible postventricular atrial blanking period (PVAB)
Receives: Device: pacemaker implantation
Standard leadActive comparatorImplantation of a standard bipolar atrial pacing lead. Optimization of the postventricular atrial blanking period (PVAB) after implantation.
Receives: Device: pacemaker implantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1 and 3 months post implantation

Secondary outcomes (3)

  1. Incidence of inappropriate mode switch in respect to lead position and ventricular stimulation frequency

    Measured: 1 and 3 months post implantation

  2. Atrial Flutter in stored EGM's

    Measured: 1 and 3 months post implantation

  3. 2:1 lock in of Atrial Flutter

    Measured: 1 and 3 months post implantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2007 (estimated)
  2. Study startDec 2006
  3. Primary completionMay 2008
  4. Study completionAug 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
204 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00512915
Sponsor's protocol ID
B84
Acronym
Avoid FFS
Status last verified
Feb 2019
First submitted
7 Aug 2007
Last updated
4 Feb 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 22745661

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing pacemaker implantation in people with Atrial Fibrillation and Bradycardia, run by Abbott Medical Devices at 10 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 1 and 3 months post implantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00512915, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.

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