NCT00157794

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2004

Longer than P75 for phase_4

Geographic Reach
1 country

14 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

July 3, 2025

Status Verified

February 1, 2017

Enrollment Period

3.8 years

First QC Date

September 9, 2005

Last Update Submit

June 30, 2025

Conditions

Arrhythmia, Sinus

Keywords

Sinus Node DiseasePacemakerDual Chamber Pacemaker

Outcome Measures

Primary Outcomes (1)

  • Amount of right ventricular pacing

    Baseline to 36 months post-implant

Secondary Outcomes (4)

  • Change in intrinsic AV delay

    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

  • Medication

    Baseline to 36 months post-implant

Interventions

Search AV+ algorithmDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with sinus node disease and an intrinsic AV delay of maximal 260 ms
  • Patients treated with a Medtronic pacemaker with Search AV+ algorithm

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Klinikum Großhadern Herzchirurgische Klinik und Poliklinik

Munich, Bavaria, 81377, Germany

Location

Internistische Praxis Dr. Med. Schade

Berlin, 13187, Germany

Location

St. Josefs Hospital

Bochum, 44791, Germany

Location

Praxis Dr. Med. Markert

Gaggenau, 76571, Germany

Location

Krankenhaus Martha Maria Halle

Halle, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

St. Vincentius Kliniken

Karlsruhe, 76135, Germany

Location

Vinzentius Krankenhaus

Landau, 76829, Germany

Location

Klinikum der Johannes-Gutenberg-Universität

Mainz, 55131, Germany

Location

Städtisches Klinikum Neunkirchen

Neunkirchen, 66538, Germany

Location

Kreiskrankenhaus Ottweiler

Ottweiler, 66564, Germany

Location

Knappschaftskrankenhaus Sulzbach, Medizinische Klinik

Sulzbach, 66280, Germany

Location

Josephs-Hospital

Warendorf, 48231, Germany

Location

Gemeinschaftspraxis Dr. Tamm/Dr. Hon

Wittenberg, Germany

Location

Related Links

MeSH Terms

Conditions

Arrhythmia, SinusSick Sinus Syndrome

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart BlockCardiac Conduction System Disease

Study Officials

  • Michael Jakob, MD

    Knappschaftskrankenhaus Sulzbach

    PRINCIPAL INVESTIGATOR

  • Peter Lamm, MD

    Klinikum der Universität München Großhadern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 12, 2005

Study Start

February 1, 2004

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

July 3, 2025

Record last verified: 2017-02

Locations

DE(14)