A PRospective, rAndomizEd Comparison of subcuTaneOous and tRansvenous ImplANtable Cardioverter Defibrillator Therapy



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:February 2011
End Date:December 2019

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Randomized Trial to Study the Efficacy and Adverse Effects of the Subcutaneous and Transvenous Implantable Cardioverter Defibrillator (ICD) in Patients With a Class I or IIa Indication for ICD Without an Indication for Pacing

This randomized controlled trial will outline the advantages and disadvantages of the
subcutaneous implantable cardioverter defibrillator (ICD) compared to the transvenous ICD.

Background of the study: The use of implantable cardioverter defibrillators (ICDs) is an
established therapy for the prevention of death from ventricular arrhythmia. Recently a new
subcutaneous ICD has been introduced, eliminating the need for transvenous lead placement in
or on the heart which is mandatory in the transvenous ICD. The new subcutaneous ICD therapy
already proved to be feasible and safe and is an approved therapy in Europe. It is likely
that the eliminated need for transvenous lead placement substantially reduces the
implantation related complications and elongates lead longevity and thus reduces
inappropriate shocks associated with lead fractures. On the other hand it is unclear whether
the lack of capability to provide antitachy-pacing (ATP) in the subcutaneous ICD may be a
limitation for patients with frequent recurrent ventricular tachycardia. This randomized
controlled trial will outline the advantages and disadvantages of the subcutaneous ICD.

Objectives of the study: (1) To compare the subcutaneous ICD to the transvenous ICD for major
adverse events (i.e. inappropriate shocks, acute and chronic implant related complications
and lead- or device related complications). (2) To determine to which degree the lack of ATP
function leads to more appropriate shocks in patients with a subcutaneous ICD.

Study design: Multicenter, prospective, randomized controlled trial with either treatment
with the transvenous ICD or subcutaneous ICD (1:1).

Study population: 2x425 patients with class I or IIa indication for ICD therapy without an
indication for pacing.

Inclusion Criteria:

- Patients 18 years and older

- Patients with class I or IIa indication for ICD therapy according to the ACC/AHA/ESC
2006 Guidelines for Management of Patients With Ventricular Arrhythmias and the
Prevention of Sudden Cardiac Death

Exclusion Criteria:

- Patients with documented therapy refractory monomorphic ventricular tachycardia

- Patients having an indication for pacing therapy

- Patients with ventricular tachycardia less than 170 bpm

- Patients failing appropriate QRS/T-wave sensing with the S-ICD ECG patient screening
tool provided by Cameron Health/Boston Scientific

- Patients with incessant ventricular tachycardia

- Patients with a serious known concomitant disease with a life expectancy of less than
one year

- Patients with circumstances that prevent follow-up (no permanent home or address,
transient, etc.)

- Patients who have had a previous ICD implant

- Patient who receive cardiac contractility modulation therapy or are likely to receive
cardiac contractility modulation therapy.

- Patients who are unable to give informed consent
We found this trial at
12
sites
350 Engle St
Englewood, New Jersey 07631
(201) 894-3000
Principal Investigator: D. Nemirovsky, MD
Englewood Hospital and Medical Center Englewood Hospital was incorporated in 1888 as a non-profit, non-sectarian...
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Englewood, NJ
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Principal Investigator: J. M. Dizon, MD
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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New York, NY
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Principal Investigator: M. F. El-Chami, MD.
Emory University Hospital As the largest health care system in Georgia and the only health...
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Atlanta, GA
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4802 10th Ave
Brooklyn, New York 11219
(718) 283-6000
Principal Investigator: Y. Greenberg, MD
Maimonides Medical Center At 103 years old, Maimonides Medical Center remains a vital and thriving...
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Brooklyn, NY
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Principal Investigator: A. B. Chicos, MD
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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Chicago, IL
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Chicago, Illinois 60637
Principal Investigator: G. A. Upadhyay, MD
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Chicago, IL
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
Principal Investigator: R Weiss, MD
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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mi
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Columbus, OH
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20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Principal Investigator: J. F. Clancy, MD
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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New Haven, CT
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New York, New York
Principal Investigator: M. Miller, MD
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New York, NY
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New York, New York 10021
Principal Investigator: J. W. Cheung, MD
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New York, NY
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Prague, 15630
Principal Investigator: P. Neuzil, MD
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Prague,
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223 N Van Dien Ave
Ridgewood, New Jersey 07450
(201) 447-8000
Principal Investigator: S. Mittal, MD
The Valley Hospital The Valley Hospital is a fully accredited, acute care, not-for-profit hospital serving...
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mi
from
Ridgewood, NJ
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