Heart Failure Clinical Trial
Official title:
Randomized Controlled Trial Comparing Internal vs External Cardioversion in ICD Patients
Verified date | January 2018 |
Source | Universitätsklinikum Köln |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Implantation of internal defibrillators, capable of monitoring the heart and shocking life
threatening arrhythmias back to normal rhythm, for patients with severe heart failure
increases the probability of survival. Arrhythmias of the atria of the heart are common in
these patients. Administering a direct current electrical shock under anesthesia
(cardioversion) is the method of choice to reestablish normal sinus rhythm in this instance.
Safety and efficacy of external electrical cardioversion (CV) in patients with ICDs was
demonstrated in several studies. Safety of internal cardioversion (shocking the heart back
into normal rhythm via the implanted defibrillator) was described in several smaller trials.
Performing external instead of internal cardioversion in patients with implanted ICDs is more
feasible for most hospitals, as CV can be performed without a programming computer and an
additional specialist present, e.g. on the intensive care ward, and device interrogation can
be done after CV at the remote ICD/pacemaker clinic.
No scientific data on safety and efficacy endpoints comparing internal vs external CV is
currently available. The aim of the study is to compare external vs internal electrical
cardioversion for atrial arrhythmias and establish a safety and efficacy profile for external
and internal cardioversion in large cohort of ICD patients.
Status | Completed |
Enrollment | 230 |
Est. completion date | January 24, 2018 |
Est. primary completion date | January 24, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
Inclusion Criteria: - Age = 18 years - Informed, written consent - Atrial arrhythmia with indication for CV - Status post ICD implantation, including CRT-D Exclusion Criteria: - Age < 18 years - Patients under guardianship or with mental disorders / disabilities - ICD implantation < 4 weeks prior to CV - ICD lead implantation < 4 weeks prior to CV - Battery in EOL, ERM or ERI, ERT - Indications of compromised leads (Impedance <200 or >2000 Ohm, Pacing threshold >5V/0.4ms), RV Sensing <4mV or RA sensing <0,1mV) |
Country | Name | City | State |
---|---|---|---|
Australia | Royal Adelaide Hospital | Adelaide | |
Germany | University Hospital Aachen | Aachen | |
Germany | Heart & Diabetes Center NRW | Bad Oeynhausen | |
Germany | University Hospital Bonn | Bonn | |
Germany | Klinikum Coburg GmbH | Coburg | |
Germany | University Hospital Cologne | Cologne | |
Germany | Vinzenz Hospital | Cologne | |
Germany | Krankenhaus Neu-Bethlehem | Göttingen | |
Germany | St.Georg Hospital | Hamburg | |
Germany | University Heart Center Hamburg | Hamburg | |
Germany | Klinikum Leverkusen GmbH | Leverkusen | |
Germany | University Hospital Lübeck | Lübeck | Schleswig-Holstein |
Germany | Klinikum Oldenburg | Oldenburg |
Lead Sponsor | Collaborator |
---|---|
Universitätsklinikum Köln | Medtronic |
Australia, Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Subgroup Analysis | The following subgroups will be analyzed: patients with CRT devices patients with quadripolar leads patients with ineffective external shock and crossover to external shock patients with AV-VV delay optimization algorithms |
immediately after CV and at follow-up | |
Primary | Combined Safety Endpoint | Any one of the following as assessed by device interrogation: a rise in threshold (at constant duration) of >0.5V exit block of one of the pacing leads loss of programming of the device a rise in shock impedance by 50% as compared to prior to CV a drop in battery voltage of =0.2V within 2 weeks |
2 weeks after CV | |
Primary | Efficacy Endpoint: restoration of sinus rhythm | Assessed by ECG, within the first seconds after DC shock application (via external CV or internal shock) - Restoration of sinus rhythm In all patients a single p wave after cardioversion counts as a successful shock. Early recurrence of AF does not count as shock failure. In case of early recurrence of AF/AT, the successful shock may be performed once more, according to randomization. Adjunctive antiarrhythmic drug administration is left to the physician's discretion |
Within 1 minute after CV | |
Secondary | Induction of ventricular fibrillation | Inadvertent induction of VF during CV, assessed by 3 or 5 lead ECG monitoring during the procedure. | during CV procedure | |
Secondary | Lead parameter indicators of impairment | Assessed by device interrogation within 15 minutes after CV and at follow-up after 2 weeks: Lead impedance > 1000 Ohm Lead impedance doubled Ventricular lead sensing < 2mV Ventricular lead sensing halved, compared to prior to CV Atrial lead sensing < 1mV Atrial lead sensing halved, compared to prior to CV |
within 15 minutes after CV and 2 weeks after CV | |
Secondary | Troponin | Comparison of Troponin T levels prior to and 3h after cardioversion | 3h after CV | |
Secondary | Recurrence at follow-up | Rhythm at follow-up assessed by ECG and device interrogation. Atrial fibrillation and atrial flutter or atrial tachycardia will be counted as recurrence. | at follow-up 2 weeks after CV |
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