Heart failure
Conditions
Interventions
Patients have an indication for a dual chamber pacemaker and will receive an
Enrhythm device (irrespective of participation in the substudy). There will be
no additional interventions in the substud
Sponsors
Medtronic Trading NL BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Heart function as measured with sensitive tissue/doppler echocardiography (including Ejection fraction, right-left ventricular synchrony) and blood values (BNP). | — |
Secondary
| Measure | Time frame |
|---|---|
| NYHA class (severity of symptoms) | — |
Countries
Netherlands
Outcome results
None listed