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. )

First Received: September 9, 2005 Last Updated: May 30, 2008 History of Changes

Sponsors and Collaborators:	Medtronic Bakken Research Center Medtronic
Information provided by:	Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:	NCT00157794

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	EnPulse Trial on Search AV+ Influence

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Arrhythmia Atrial Fibrillation Heart Failure

U.S. FDA Resources

Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:

Amount of right ventricular pacing

Secondary Outcome Measures:

Change in intrinsic AV delay
Hospitalizations because of symptomatic heart failure
Hospitalizations because of symptomatic atrial fibrillation
Medication

Estimated Enrollment:	300
Study Start Date:	February 2004
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00157794

Locations

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

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:

Knappschaftskrankenhaus Sulzbach This link exits the ClinicalTrials.gov site

Klinikum der Universität München -Großhadern This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CEN_G_CA_2
Study First Received:	September 9, 2005
Last Updated:	May 30, 2008
ClinicalTrials.gov Identifier:	NCT00157794 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Medtronic Bakken Research Center:

Sinus Node Disease
Pacemaker
Dual Chamber Pacemaker

Study placed in the following topic categories:

Heart Diseases
Arrhythmia, Sinus
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Arrhythmia, Sinus
Cardiovascular Diseases
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on September 11, 2009