Impact of intraprocedural ventilation on lead function and the occurence of phrenic nerve stimulation in patients receiving CRT-D therapy

Impact of intraprocedural ventilation on lead function and the occurence of phrenic nerve stimulation in patients receiving CRT-D therapy - ICD-BREATHE

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00012406

Enrollment

400

Registered

2017-05-19

Start date

2017-06-01

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

I50 Z95.0 Y82.8

Interventions

Group 1: Patients receiving CRT-D implantation under spontaneous ventilation - retrospective data analysis Group 2: Patients receiving CRT-D implantation during general anesthesia and controlled venti

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: o age > 18 years o patients having CRT-D-Implantation in the period of 08-2009 to 06-2010.

Exclusion criteria

Exclusion criteria: o lead dysfunction during CRT-D implantation o lacking follow-up-data

Design outcomes

Primary

Measure	Time frame
Retrospective data analysis regarding occurrence of a clinical apparent phrenic nerve stimulation within 6 years post CRT-D implantation. Phrenic nerve stimulation will be recorded by patients history and ICD (implantable cardioverter defibrillator) interrogation every 6 months during a follow up period of 6 years	—

Secondary

Measure	Time frame
1. Occurrence of lead dysfunction (increased pacing threshold, loss of lead sensitivity or alterations of the lead impedance) with respect to intraoperative ventilation. Lead dysfuction will be recorded during ICD interrogation every 6 months during a follow up period of 6 years 2. Occurence of lead dysfunction with respect to body weight	—

Countries

Germany

Contacts

Public ContactChristian von Bary

Rotkreuzklinikum München

sinem.dedeoglu@swmbrk.de089-1303-2501

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026