Perioperative Management Evaluation in Patients With CIED

NCT04331249 | Recruiting

• 1 other identifier: EVINCE_KHF
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

Brief Summary

Background: Recommendations for peri-operative management in patients with implanted cardiac electronic devices (CIED) are often based on older data from case reports and small collectives. Objective: To evaluate the peri-operative management and outcome of patients with implanted CIED undergoing non-CIED related surgery or catheter-interventional procedures in clinical routine. Study design: bi-center, non-randomized, observational registry, retrospective data-collection, on-going prospective patient enrollment, descriptive statistics Primary endpoint: number and type of peri-operative adverse device related events (ADE) Secondary endpoints: pre-interventional data (patient characteristics, data from CIED interrogation); peri-interventional data (type of surgery/intervention, anesthesiology techniques, any AE), postinterventional data (data from post-interventional CIED interrogation, need for reprogramming / device revision). Inclusion criteria: implanted CIED, non-CIED related surgical or catheter-based intervention, peri-procedural CIED interrogation, age \>18 years Exclusion criteria: no implanted CIED, no data from any peri-procedural CIED interrogation available Patient enrollment: retrospectively beginning from 2008, further on-going prospective inclusion Sample size: For the observational study, there is no pre-specified sample size. Data from more than 500 patients undergoing \> 700 interventions are expected.

Conditions

Cardiac Pacemaker Malfunction; ICD Malfunction; Cardiac Pacemaker Electrical Interference; Anesthesia Complication; Surgery--Complications

Keywords

pacemaker; implanted cardioverter defibrillator; cardiac resynchronisation therapy; management, peri-operative

Outcome Measures

Primary Outcomes (1)

• surgery or catheter-based procedure related (S)ADE

  any (S)ADE related to the surgical or catheter-based procedure

  1 month post-procedural

Secondary Outcomes (3)

• device: post-procedural pacing threshold increase

  1 month post-procedural

• device: post-procedural sensing decrease

  1 month post-procedural

• device: post-procedural lead impedance

  1 month post-procedural

Interventions

surgery or catheter based cardiac procedure (catheter ablation) PROCEDURE

patients with implanted CIED (pacemaker, ICD or CRT) that undergo any surgery or any catheter based cardiac procedure (e.g. radiofrequency ablation)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Enrollment of all consecutive patients according to the inclusion criteria, undergoing surgery or catheter-ablation at the Klinikum Fuerth or Klinikum Nueremberg. Data collection will be * retrospectively beginning from 2008, * on-going with further prospective data collection and patient enrollment. If possible, patients will be enrolled at pre-interventional device interrogation. If there is no pre-interventional device interrogation (e.g. in case of urgent or emergency surgery), patients will be enrolled retrospectively.

You may qualify if:

• implanted CIED (e.g. pacemaker, ICD, CRT),
• performed (non-CIED related) surgical or catheter-based procedure,
• data from peri-procedural CIED interrogation available
• age \>18 years

You may not qualify if:

• no implanted CIED,
• no data from any peri-interventional CIED interrogation available

Sponsors & Collaborators

• Klinikum-Fuerth: lead
• Klinikum Nürnberg: collaborator

Study Sites (2)

Klinikum Fuerth

Fürth, Bavaria, 90766, Germany

RECRUITING

Klinikum Nuernberg

Nuremberg, Bavaria, 90471, Germany

RECRUITING

MeSH Terms

Interventions

Surgical Procedures, Operative; Catheter Ablation

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques

Study Officials

• Dirk Bastian, MD

  Klinikum Fuerth, European Society of Cardiology, European Heart Rhythm Society

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dirk Bastian, MD

CONTACT

+49 (0)911 7580 1101; dirk.bastian@klinikum-fuerth.de

Laura Vitali-Serdoz, MD

CONTACT

+49 (0)911 7580 1101; laura.vitali-serdoz@klinikum-fuerth.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 2, 2020
• Study Start: November 27, 2018
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2030
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

DE (2)