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EnTRINSIC - EnPulse Trial on Search AV+ Influence

NCT ID: NCT00157794

Last Updated: 2025-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2007-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Arrhythmia, Sinus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Search AV+ algorithm

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Jakob, MD

Role: PRINCIPAL_INVESTIGATOR

Knappschaftskrankenhaus Sulzbach

Peter Lamm, MD

Role: PRINCIPAL_INVESTIGATOR

Klinikum der Universität München Großhadern

Locations

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Klinikum Großhadern Herzchirurgische Klinik und Poliklinik

Munich, Bavaria, Germany

Site Status

Internistische Praxis Dr. Med. Schade

Berlin, , Germany

Site Status

St. Josefs Hospital

Bochum, , Germany

Site Status

Praxis Dr. Med. Markert

Gaggenau, , Germany

Site Status

Krankenhaus Martha Maria Halle

Halle, , Germany

Site Status

Universitätsklinikum Heidelberg

Heidelberg, , Germany

Site Status

St. Vincentius Kliniken

Karlsruhe, , Germany

Site Status

Vinzentius Krankenhaus

Landau, , Germany

Site Status

Klinikum der Johannes-Gutenberg-Universität

Mainz, , Germany

Site Status

Städtisches Klinikum Neunkirchen

Neunkirchen, , Germany

Site Status

Kreiskrankenhaus Ottweiler

Ottweiler, , Germany

Site Status

Knappschaftskrankenhaus Sulzbach, Medizinische Klinik

Sulzbach, , Germany

Site Status

Josephs-Hospital

Warendorf, , Germany

Site Status

Gemeinschaftspraxis Dr. Tamm/Dr. Hon

Wittenberg, , Germany

Site Status

Countries

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Germany

Related Links

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http://www.kk-sulzbach.de

Knappschaftskrankenhaus Sulzbach

http://hch.klinikum.uni-muenchen.de

Klinikum der Universität München -Großhadern

Other Identifiers

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CEN_G_CA_2

Identifier Type: -

Identifier Source: org_study_id

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