Safety of External Electrocardioversion in Device Patients

NCT02245009 | Unknown DMC

• 1 other identifier: UKK-SEED-2014
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Arrhythmias of the atria of the heart are a common comorbidity in patients with cardiac rhythm management devices, such as pacemakers and implantable cardioverter/defibrillators (ICD). External electrical cardioversion is an established method to achieve rhythm control (restore normal sinus rhythm) in patients with atrial arrhythmia. Little data on safety and efficacy of external electrical cardioversion in patients with cardiac rhythm management devices exists. Thus, available data on the safety of external electrical cardioversion in cardiac rhythm management patients lacks statistical power to accurately reflect the true hazard of external electrical cardioversion in patients with cardiac rhythm management devices. The aim is to systematically include and follow all patients with cardiac rhythm management devices presenting for external electrical cardioversion, to analyse the effects of external electrical cardioversion on leads and devices.

Conditions

Atrial Arrhythmia

Outcome Measures

Primary Outcomes (1)

• Composite safety endpoint: Changes of lead and device parameters

  assessed by device interrogation, if any of the following criteria is met: * a rise in threshold (at constant pulse duration) of \>1V * exit block of any of the pacing leads * loss of programming of the device * rise in shock impedance by 50% * rise in charge time by 50% * drop in battery voltage of ≥0.2V within \< 6 weeks

  2 weeks after CV

Secondary Outcomes (7)

• Efficacy Endpoint

  within 15 minutes after CV

• Late changes of lead parameters

  2 weeks after CV

• Inadvertent induction of ventricular fibrillation

  10 seconds after CV

• Composite endpoint: Early lead changes

  within 15 minutes after CV

• Loss of programming

  within 15 minutes after CV

Study Arms (3)

Pacemaker patients

Patients with pacemaker, presenting for cardioversion.

Procedure: Cardioversion

ICD patients

Patients with ICD, presenting for cardioversion.

Procedure: Cardioversion

CRT patients

Patients with CRT device, presenting for cardioversion.

Procedure: Cardioversion

Interventions

Cardioversion PROCEDURE

CRT patients; ICD patients; Pacemaker patients

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients with implanted cardiac rhythm devices (pacemakers, ICD and CRT)

You may qualify if:

• Age ≥ 18 years
• Informed, written consent
• Atrial or ventricular arrhythmia with indication for CV
• Status post CRM implantation, including CRT-D

You may not qualify if:

• Age \< 18 years
• Patients under guardianship or with mental disorders / disabilities
• lead implantation \< 4 weeks prior to CV
• contraindications for eCV or transoesophageal echocardiographie (TOE)

Sponsors & Collaborators

• Universitätsklinikum Köln: lead

Study Sites (1)

University Hospital Cologne

Cologne, 50937, Germany

RECRUITING

MeSH Terms

Interventions

Electric Countershock

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics

Study Officials

• Jakob Lüker, Dr.

  University Hospital Cologne

  PRINCIPAL INVESTIGATOR

• Daniel Steven, Prof. Dr.

  University Hospital Cologne

  STUDY DIRECTOR

Central Study Contacts

Jakob Lüker, Dr.

CONTACT

+49221478; jakob.lueker@uk-koeln.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2014
• First Posted: September 19, 2014
• Study Start: September 1, 2014
• Primary Completion: November 1, 2018
• Study Completion: December 1, 2018
• Last Updated: November 6, 2017

Record last verified: 2017-11

Locations

DE (1)