Candidate Predictors of Changes in Heart functio

Phase 4

Recruiting

• Conditions: Heart failure; 10014662

• Registration Number: NL-OMON31564
• Lead Sponsor: Medtronic Trading NL BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

1) Class I/II indication for dual chamber pacemaker
2) Previous implant of an Enrhythm dual chamber pacemaker since max 2 weeks
3) Documented history of atrial arrhythmias in last 12 months
4) Randomised assignment to control group in the Minerva main study

Exclusion Criteria

- Younger than 18 years
- History of permanent atrial fibrillation
- Candidates for implantable defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT)
- Permanent AV block or AV-node ablation
- Anticipated major cardiac surgery within the course of the study
- Random assignment to DDDRP group or MVP group

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Heart function as measured with sensitive tissue/doppler echocardiography<br /><br>(including Ejection fraction, right-left ventricular synchrony) and blood<br /><br>values (BNP). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>NYHA class (severity of symptoms)</p><br>