ADVANCE CRT - D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy (ADVANCE-CRTD)
This study has been completed.
Sponsor:
Medtronic Bakken Research Center
Information provided by:
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00147290
First received: September 6, 2005
Last updated: June 11, 2009
Last verified: June 2009
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| First Received Date ICMJE | September 6, 2005 | ||||||||||||||||||||||||||||||||
| Last Updated Date | June 11, 2009 | ||||||||||||||||||||||||||||||||
| Start Date ICMJE | February 2004 | ||||||||||||||||||||||||||||||||
| Primary Completion Date | April 2007 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
Efficacy of Anti Tachycardia Pacing (ATP) Therapy (Burst, 8 Pulses, 88 %, 1 Sequence) to Terminate All Types of Ventricular Tachycardia. [ Time Frame: one year ] [ Designated as safety issue: No ] | ||||||||||||||||||||||||||||||||
| Original Primary Outcome Measures ICMJE |
Compare efficacy of ATP therapy (Burst, 8 pulses, 88 %, 1 sequence) to terminate all types of ventricular tachycardia when delivered in the right ventricle only versus both ventricles resulting in a 10 % difference in favour of BIV ATP. | ||||||||||||||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT00147290 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||||||||||||||
| Brief Title ICMJE | ADVANCE CRT - D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy | ||||||||||||||||||||||||||||||||
| Official Title ICMJE | ADVANCE CRT - D: ATP Delivery for Painless ICD Therapy | ||||||||||||||||||||||||||||||||
| Brief Summary | To compare the efficacy of RV and BiV ATP for the termination of ventricular arrhythmias in patients who are candidates to a cardiac resynchronisation therapy (CRT) and have a Class I or IIA indication for ICD implantation. The hypothesis of delivering ATP from different sites (RV or BIV) has never been evaluated in a prospective, controlled and randomized study. |
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| Detailed Description | Main objective: Compare efficacy of ATP therapy (Burst, 8 pulses, 88 %, 1 sequence) to terminate all types of ventricular tachycardia (all VTs (FVT+VT)) when delivered in the right ventricle (RV) only versus both ventricles (BiV) resulting in a 10 % difference in favour of BIV ATP Secondary objectives:
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| Study Type ICMJE | Interventional | ||||||||||||||||||||||||||||||||
| Study Phase | Phase 4 | ||||||||||||||||||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Device: Implantable Cardiac Defibrillator
Implantable cardiac defibrillator with programmable Fast Ventricular tachycardia detection (FVT) window
Other Name: ICD |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||||||||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||||||||||||||||||||||
| Enrollment ICMJE | 526 | ||||||||||||||||||||||||||||||||
| Completion Date | January 2008 | ||||||||||||||||||||||||||||||||
| Primary Completion Date | April 2007 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||||||||||||||||||||||
| Ages | 18 Years and older | ||||||||||||||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||||||||||||||
| Location Countries ICMJE | Italy | ||||||||||||||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||||||||||||||
| NCT Number ICMJE | NCT00147290 | ||||||||||||||||||||||||||||||||
| Other Study ID Numbers ICMJE | 400ACRT | ||||||||||||||||||||||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||||||||||||||||||||||
| Responsible Party | Elisabetta Santi, Medtronic | ||||||||||||||||||||||||||||||||
| Study Sponsor ICMJE | Medtronic Bakken Research Center | ||||||||||||||||||||||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||||||||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | Medtronic Bakken Research Center | ||||||||||||||||||||||||||||||||
| Verification Date | June 2009 | ||||||||||||||||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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