Rhythm devices demand evidence that lasts years.
Pacemakers, ICDs, CRT, ablation catheters and EP mapping sit at the top of the risk scale. We run the Class III and active implantable investigations, the long-term PMCF and the registry evidence that a Notified Body expects for cardiac rhythm management devices.
Platinum Award 2026
Eclevar MedTech and Milo took the Platinum Award at xShare & EUCROF.
Top prize in the xShare x European CRO Federation "EHDS & Clinical Research" Open Call, awarded to Eclevar MedTech and its Milo Health platform, presented at the EUCROF 2026 conference in Amsterdam.
Horizon Europe · Grant Agreement No. 101136734 · Amsterdam, 2 Feb 2026
Trusted by MedTech manufacturers.
Device leaders rely on Eclevar for cardiology and rhythm management evidence. Read all client success stories.
Rhythm evidence a reviewer will accept.
Dr Mark DaCosta, COO and former TÜV SÜD reviewer, leads a team that knows how a Notified Body scrutinises active implantable and Class III cardiac devices. We design lead-survivorship endpoints, long-term follow-up and PMCF so the benefit-risk case holds, with in-house CRAs rather than outsourced monitoring.
The full arrhythmia device landscape.
From high-energy implants to diagnostic monitors, we cover the cardiac rhythm management portfolio, connecting each to our wider cardiovascular clinical strategy.
Pacemakers & CRT
Single, dual-chamber and biventricular resynchronisation devices, including leadless systems.
ICDs
Implantable cardioverter defibrillators, transvenous and subcutaneous, with shock-therapy endpoints.
Ablation catheters
Radiofrequency, cryo and pulsed-field ablation for atrial fibrillation and other arrhythmias.
EP mapping systems
Electrophysiology mapping and navigation platforms, hardware and software.
Loop recorders
Implantable and external monitors for long-term arrhythmia detection.
Leads & accessories
Lead survivorship and extraction data, central to the long-term benefit-risk profile.
Endpoints built for rhythm devices.
We combine device performance and long-term safety, captured through clinical investigations and registry-based real-world evidence.
Does the device do its job
- Sensing, pacing and shock-therapy performance
- Procedural success and acute efficacy
- Arrhythmia recurrence and burden
- Battery longevity and device diagnostics
Does it stay safe for years
- Lead survivorship and complication rates
- Infection and revision tracking
- Multi-year PMCF follow-up
- Registry-based survivorship data
From protocol to PMCF, in five steps.
Aligned with your regulatory strategy and Clinical Evaluation Report.
Feasibility
Assess endpoints, sites and the evidence gap for your device.
Protocol
Design a Class III or AIMD protocol to ISO 14155:2026 and GCP.
Conduct
Run sites with in-house CRAs across the UK, Germany, France and Sweden.
Analyze
Statistical analysis of performance and long-term safety.
PMCF
Registry and observational follow-up feeding the CER.
Rhythm device questions sponsors ask us.
Which cardiac arrhythmia devices does Eclevar support?
Pacemakers, implantable cardioverter defibrillators (ICDs), cardiac resynchronisation therapy (CRT) devices, ablation catheters, electrophysiology mapping systems and implantable loop recorders, including Class III and active implantable (AIMD) devices.
How are arrhythmia devices classified under EU MDR?
Most cardiac rhythm management implants are Class III or active implantable devices under EU MDR 2017/745, which triggers the highest clinical evidence expectations, mandatory PMCF and, for implantables, an SSCP.
What clinical endpoints matter for rhythm management trials?
Endpoints typically combine device performance (sensing, pacing and shock therapy), procedural safety, arrhythmia recurrence, lead performance and long-term survival, captured over multi-year follow-up.
Can registries support PMCF for arrhythmia devices?
Yes. Registry-based PMCF and real-world evidence are well suited to rhythm management devices, where long-term lead and device survivorship are central to the benefit-risk profile.
Does Eclevar run the sites itself?
Yes. Eclevar deploys in-house CRAs across the UK, Germany, France and Sweden, handling site initiation, ethics submissions and monitoring with its own team rather than outsourcing.
Build the rhythm evidence your device needs.
Talk to our team about your pacemaker, ICD, ablation or EP device, its class and the fastest compliant route to Notified Body ready clinical evidence.
Book a free consultation