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Preliminary evaluation of defibrillator lead curvature in vivo

Preliminary evaluation of defibrillator lead curvature in vivo - Lead Curvature study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON47524
Enrollment
40
Registered
2018-03-06
Start date
2018-04-11
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ICD (implantable cardiac defibrillator) implantation technique

Interventions

Implantation technique
Lead design
X-ray

Sponsors

Cardiologie
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: -Age 18-90 years -Patients with implantable defibrillator systems with either Reliance 4-Site or Reliance 4-Front leads who are followed at the University Medical Center, Utrecht -Patients capable of providing informed consent.

Exclusion criteria

Exclusion criteria: Pregnancy

Design outcomes

Primary

MeasureTime frame
To quantify the in vivo cyclic curvature in the extravenous region and connector region of Reliance 4-Site and Reliance 4-Front leads for a random sample of patients implanted with ICD and CRT-D systems.

Secondary

MeasureTime frame
1) to correlate in vivo cyclic curvature in the extravenous region and connector region with certain predefined dimensions that locate the defined lead trajectory and locate the pulse generator with respect to anatomical landmarks. 2) to compare in vivo cyclic curvature between the Reliance 4-Site and Reliance 4-Front leads. The stiffness of both leads is different, which could influence curvature

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)