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EnTRINSIC - EnPulse Trial on Search AV+ Influence

This study has been terminated.
(Protocol pre-specified interim analysis showed that difference between groups was too small to reach significance.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00157794
First Posted: September 12, 2005
Last Update Posted: February 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Bakken Research Center
  Purpose
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.

Condition Intervention Phase
Arrhythmia, Sinus Device: Search AV+ algorithm Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EnPulse Trial on Search AV+ Influence

Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • Amount of right ventricular pacing [ Time Frame: Baseline to 36 months post-implant ]

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

Enrollment: 135
Study Start Date: February 2004
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00157794


Locations
Germany
Klinikum Großhadern Herzchirurgische Klinik und Poliklinik
Munich, Bavaria, Germany, 81377
Internistische Praxis Dr. Med. Schade
Berlin, Germany, 13187
St. Josefs Hospital
Bochum, Germany, 44791
Praxis Dr. Med. Markert
Gaggenau, Germany, 76571
Krankenhaus Martha Maria Halle
Halle, Germany
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
St. Vincentius Kliniken
Karlsruhe, Germany, 76135
Vinzentius Krankenhaus
Landau, Germany, 76829
Klinikum der Johannes-Gutenberg-Universität
Mainz, Germany, 55131
Städtisches Klinikum Neunkirchen
Neunkirchen, Germany, 66538
Kreiskrankenhaus Ottweiler
Ottweiler, Germany, 66564
Knappschaftskrankenhaus Sulzbach, Medizinische Klinik
Sulzbach, Germany, 66280
Josephs-Hospital
Warendorf, Germany, 48231
Gemeinschaftspraxis Dr. Tamm/Dr. Hon
Wittenberg, Germany
Sponsors and Collaborators
Medtronic Bakken Research Center
Medtronic
Investigators
Principal Investigator: Michael Jakob, MD Knappschaftskrankenhaus Sulzbach
Principal Investigator: Peter Lamm, MD Klinikum der Universität München Großhadern
  More Information

Additional Information:
Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT00157794     History of Changes
Other Study ID Numbers: CEN_G_CA_2
First Submitted: September 9, 2005
First Posted: September 12, 2005
Last Update Posted: February 15, 2017
Last Verified: February 2017

Keywords provided by Medtronic Bakken Research Center:
Sinus Node Disease
Pacemaker
Dual Chamber Pacemaker

Additional relevant MeSH terms:
Arrhythmia, Sinus
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes