Clinical trial NCT00157794: EnTRINSIC - EnPulse Trial on Search AV+ Influence
Official title: EnPulse Trial on Search AV+ Influence
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Arrhythmia, Sinus
Keywords: Sinus Node Disease
Pacemaker
Dual Chamber Pacemaker
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2005-09-12
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Amount of right ventricular pacing
timeFrame: Baseline to 36 months post-implant
Secondary outcomes:
measure: Change in intrinsic AV delay
timeFrame: Baseline to 36 months post-implant
measure: Hospitalizations because of symptomatic heart failure
timeFrame: Baseline to 36 months post-implant
measure: Hospitalizations because of symptomatic atrial fibrillation
timeFrame: Baseline to 36 months post-implant
measure: Medication
timeFrame: Baseline to 36 months post-implant
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinikum Großhadern Herzchirurgische Klinik und Poliklinik
state: Bavaria
city: Berlin
country: Germany
facility: Internistische Praxis Dr. Med. Schade
city: Bochum
country: Germany
facility: St. Josefs Hospital
city: Gaggenau
country: Germany
facility: Praxis Dr. Med. Markert
city: Halle
country: Germany
facility: Krankenhaus Martha Maria Halle
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Karlsruhe
country: Germany
facility: St. Vincentius Kliniken
city: Landau
country: Germany
facility: Vinzentius Krankenhaus
city: Mainz
country: Germany
facility: Klinikum der Johannes-Gutenberg-Universität
city: Neunkirchen
country: Germany
facility: Städtisches Klinikum Neunkirchen
city: Ottweiler
country: Germany
facility: Kreiskrankenhaus Ottweiler
city: Sulzbach
country: Germany
facility: Knappschaftskrankenhaus Sulzbach, Medizinische Klinik
city: Warendorf
country: Germany
facility: Josephs-Hospital
city: Wittenberg
country: Germany
facility: Gemeinschaftspraxis Dr. Tamm/Dr. Hon
Study officials:
affiliation: Knappschaftskrankenhaus Sulzbach
name: Michael Jakob, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinikum der Universität München Großhadern
name: Peter Lamm, MD
role: PRINCIPAL_INVESTIGATOR
References: