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EnTRINSIC - EnPulse Trial on Search AV+ Influence

Primary Purpose

Arrhythmia, Sinus

Status

Terminated

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

Search AV+ algorithm

About this trial

This is an interventional treatment trial for Arrhythmia, Sinus focused on measuring Sinus Node Disease, Pacemaker, Dual Chamber Pacemaker

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Outcomes

Primary Outcome Measures

Amount of right ventricular pacing

Secondary Outcome Measures

Change in intrinsic AV delay

Hospitalizations because of symptomatic heart failure

Hospitalizations because of symptomatic atrial fibrillation

Medication

Full Information

NCT ID

NCT00157794

First Posted

September 9, 2005

Last Updated

February 14, 2017

Sponsor

Medtronic Bakken Research Center

Collaborators

Medtronic

1. Study Identification

Unique Protocol Identification Number

NCT00157794

Brief Title

EnTRINSIC - EnPulse Trial on Search AV+ Influence

Official Title

EnPulse Trial on Search AV+ Influence

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Terminated

Why Stopped

Protocol pre-specified interim analysis showed that difference between groups was too small to reach significance.

Study Start Date

February 2004 (undefined)

Primary Completion Date

November 2007 (Actual)

Study Completion Date

November 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medtronic Bakken Research Center

Collaborators

Medtronic

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arrhythmia, Sinus

Keywords

Sinus Node Disease, Pacemaker, Dual Chamber Pacemaker

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

135 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Search AV+ algorithm

Primary Outcome Measure Information:

Title

Amount of right ventricular pacing

Time Frame