EnTRINSIC - EnPulse Trial on Search AV+ Influence

June 30, 2025 updated by: Medtronic Cardiac Rhythm and Heart Failure

EnPulse Trial on Search AV+ Influence

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.

Study Overview

Status

Terminated

Conditions

Arrhythmia, Sinus

Intervention / Treatment

Device: Search AV+ algorithm

Study Type

Interventional

Enrollment (Actual)

135

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- - Berlin, Germany, 13187
    - Internistische Praxis Dr. Med. Schade
  - Bochum, Germany, 44791
    - St. Josefs Hospital
  - Gaggenau, Germany, 76571
    - Praxis Dr. Med. Markert
  - Halle, Germany
    - Krankenhaus Martha Maria Halle
  - Heidelberg, Germany, 69120
    - Universitätsklinikum Heidelberg
  - Karlsruhe, Germany, 76135
    - St. Vincentius Kliniken
  - Landau, Germany, 76829
    - Vinzentius Krankenhaus
  - Mainz, Germany, 55131
    - Klinikum der Johannes-Gutenberg-Universität
  - Neunkirchen, Germany, 66538
    - Städtisches Klinikum Neunkirchen
  - Ottweiler, Germany, 66564
    - Kreiskrankenhaus Ottweiler
  - Sulzbach, Germany, 66280
    - Knappschaftskrankenhaus Sulzbach, Medizinische Klinik
  - Warendorf, Germany, 48231
    - Josephs-Hospital
  - Wittenberg, Germany
    - Gemeinschaftspraxis Dr. Tamm/Dr. Hon
- Bavaria
  - Munich, Bavaria, Germany, 81377
    - Klinikum Großhadern Herzchirurgische Klinik und Poliklinik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Amount of right ventricular pacing Time Frame: Baseline to 36 months post-implant	Baseline to 36 months post-implant

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in intrinsic AV delay Time Frame: Baseline to 36 months post-implant	Baseline to 36 months post-implant
Hospitalizations because of symptomatic heart failure Time Frame: Baseline to 36 months post-implant	Baseline to 36 months post-implant
Hospitalizations because of symptomatic atrial fibrillation Time Frame: Baseline to 36 months post-implant	Baseline to 36 months post-implant
Medication Time Frame: Baseline to 36 months post-implant	Baseline to 36 months post-implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Collaborators

Medtronic

Investigators

Principal Investigator: Michael Jakob, MD, Knappschaftskrankenhaus Sulzbach
Principal Investigator: Peter Lamm, MD, Klinikum der Universität München Großhadern

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 10, 2005

First Posted (Estimated)

September 12, 2005

Study Record Updates

Last Update Posted (Actual)

July 3, 2025

Last Update Submitted That Met QC Criteria

June 30, 2025

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CEN_G_CA_2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.