EnTRINSIC - EnPulse Trial on Search AV+ Influence

February 14, 2017 updated by: Medtronic Bakken Research Center

EnPulse Trial on Search AV+ Influence

Right ventricular apical pacing in patients treated with a pacemaker is unnecessary in cases where patients have stable atrioventricular (AV)-conduction. Recent findings demonstrate that pacing even might have unfavourable effects, especially if patients suffer from additional cardiac diseases such as heart failure. The Search AV+ algorithm was designed to avoid ventricular pacing and support intrinsic AV-conduction in order to avoid possible detrimental effects of right ventricular apical pacing. The goal of the EnTRINSIC study is to assess the amount of ventricular stimulation, the amount of hospitalizations, the occurrence of atrial fibrillation and the usage of drugs in patients treated with pacemakers with an activated Search AV+ algorithm versus patients treated with an individual optimization of the pacemaker settings to minimize the amount of right ventricular pacing.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

135

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13187
        • Internistische Praxis Dr. Med. Schade
      • Bochum, Germany, 44791
        • St. Josefs Hospital
      • Gaggenau, Germany, 76571
        • Praxis Dr. med. Markert
      • Halle, Germany
        • Krankenhaus Martha Maria Halle
      • Heidelberg, Germany, 69120
        • Universitätsklinikum Heidelberg
      • Karlsruhe, Germany, 76135
        • St. Vincentius Kliniken
      • Landau, Germany, 76829
        • Vinzentius Krankenhaus
      • Mainz, Germany, 55131
        • Klinikum der Johannes-Gutenberg-Universitat
      • Neunkirchen, Germany, 66538
        • Städtisches Klinikum Neunkirchen
      • Ottweiler, Germany, 66564
        • Kreiskrankenhaus Ottweiler
      • Sulzbach, Germany, 66280
        • Knappschaftskrankenhaus Sulzbach, Medizinische Klinik
      • Warendorf, Germany, 48231
        • Josephs-Hospital
      • Wittenberg, Germany
        • Gemeinschaftspraxis Dr. Tamm/Dr. Hon
    • Bavaria
      • Munich, Bavaria, Germany, 81377
        • Klinikum Großhadern Herzchirurgische Klinik und Poliklinik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with sinus node disease and an intrinsic AV delay of maximal 260 ms
  • Patients treated with a Medtronic pacemaker with Search AV+ algorithm

Exclusion Criteria:

  • Patients with documented persistent atrial fibrillation within 6 months before implantation and slow AV-conduction
  • New York Heart Association (NYHA) III/IV
  • Instable angina pectoris
  • Heart valve vitium
  • Persistent AV-block II and III
  • Early diastolic mitral regurgitation
  • Implantable cardioverter defibrillator
  • Participation in other clinical studies
  • Pregnancy or unreliable birth control
  • AV-block under strain

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Amount of right ventricular pacing
Time Frame: Baseline to 36 months post-implant
Baseline to 36 months post-implant

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in intrinsic AV delay
Time Frame: Baseline to 36 months post-implant
Baseline to 36 months post-implant
Hospitalizations because of symptomatic heart failure
Time Frame: Baseline to 36 months post-implant
Baseline to 36 months post-implant
Hospitalizations because of symptomatic atrial fibrillation
Time Frame: Baseline to 36 months post-implant
Baseline to 36 months post-implant
Medication
Time Frame: Baseline to 36 months post-implant
Baseline to 36 months post-implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Bakken Research Center

Collaborators

Medtronic

Investigators

  • Principal Investigator: Michael Jakob, MD, Knappschaftskrankenhaus Sulzbach
  • Principal Investigator: Peter Lamm, MD, Klinikum der Universität München Großhadern

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 10, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Actual)

February 15, 2017

Last Update Submitted That Met QC Criteria

February 14, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEN_G_CA_2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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