EnTRINSIC - EnPulse Trial on Search AV+ Influence

Phase 4

Terminated

• Conditions: Arrhythmia, Sinus

• Registration Number: NCT00157794
• Lead Sponsor: Medtronic Bakken Research Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-10
• Study First Posted: 2005-09-12
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-14
• Last Update Posted: 2017-02-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 135

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Amount of right ventricular pacing	Baseline to 36 months post-implant

Secondary Outcome Measures

Name	Time	Method
Change in intrinsic AV delay	Baseline to 36 months post-implant
Medication	Baseline to 36 months post-implant
Hospitalizations because of symptomatic heart failure	Baseline to 36 months post-implant
Hospitalizations because of symptomatic atrial fibrillation	Baseline to 36 months post-implant

Trial Locations

Locations (14)

Klinikum Großhadern Herzchirurgische Klinik und Poliklinik; 🇩🇪 Munich, Bavaria, Germany

St. Josefs Hospital; 🇩🇪 Bochum, Germany

St. Vincentius Kliniken; 🇩🇪 Karlsruhe, Germany

Internistische Praxis Dr. Med. Schade; 🇩🇪 Berlin, Germany

Josephs-Hospital; 🇩🇪 Warendorf, Germany

Städtisches Klinikum Neunkirchen; 🇩🇪 Neunkirchen, Germany

Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Klinikum der Johannes-Gutenberg-Universität; 🇩🇪 Mainz, Germany

Knappschaftskrankenhaus Sulzbach, Medizinische Klinik; 🇩🇪 Sulzbach, Germany

Gemeinschaftspraxis Dr. Tamm/Dr. Hon; 🇩🇪 Wittenberg, Germany

Praxis Dr. Med. Markert; 🇩🇪 Gaggenau, Germany

Krankenhaus Martha Maria Halle; 🇩🇪 Halle, Germany

Vinzentius Krankenhaus; 🇩🇪 Landau, Germany

Kreiskrankenhaus Ottweiler; 🇩🇪 Ottweiler, Germany