EnTRINSIC - EnPulse Trial on Search AV+ Influence

Arrhythmia, Sinus Clinical Trial

Official title:

EnPulse Trial on Search AV+ Influence

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00157794
• Other study ID #: CEN_G_CA_2
• Status: Terminated
• Phase: Phase 4
• First received: September 9, 2005
• Last updated: February 14, 2017
• Start date: February 2004
• Est. completion date: November 2007

Study information

• Verified date: February 2017
• Source: Medtronic Bakken Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 135
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmia, Sinus

Intervention

Device:
• Search AV+ algorithm

Locations

Country	Name	City	State
Germany	Internistische Praxis Dr. Med. Schade	Berlin
Germany	St. Josefs Hospital	Bochum
Germany	Praxis Dr. Med. Markert	Gaggenau
Germany	Krankenhaus Martha Maria Halle	Halle
Germany	Universitätsklinikum Heidelberg	Heidelberg
Germany	St. Vincentius Kliniken	Karlsruhe
Germany	Vinzentius Krankenhaus	Landau
Germany	Klinikum der Johannes-Gutenberg-Universität	Mainz
Germany	Klinikum Großhadern Herzchirurgische Klinik und Poliklinik	Munich	Bavaria
Germany	Städtisches Klinikum Neunkirchen	Neunkirchen
Germany	Kreiskrankenhaus Ottweiler	Ottweiler
Germany	Knappschaftskrankenhaus Sulzbach, Medizinische Klinik	Sulzbach
Germany	Josephs-Hospital	Warendorf
Germany	Gemeinschaftspraxis Dr. Tamm/Dr. Hon	Wittenberg

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center	Medtronic

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of right ventricular pacing		Baseline to 36 months post-implant
Secondary	Change in intrinsic AV delay		Baseline to 36 months post-implant
Secondary	Hospitalizations because of symptomatic heart failure		Baseline to 36 months post-implant
Secondary	Hospitalizations because of symptomatic atrial fibrillation		Baseline to 36 months post-implant
Secondary	Medication		Baseline to 36 months post-implant

External Links

•   Klinikum der Universität München -Großhadern
•   Knappschaftskrankenhaus Sulzbach