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The purpose of this study is to estimate and quantify the difference in efficacy of two sequences of ATP therapies (burst 15 pulses, 88% versus burst 8 pulses, 88%) during an episode of spontaneous rhythms classified as fast ventricular tachycardia (FVT) via ventricular fibrillation (VF) in patients who have a Class I or II A indication for ICD implantation, and thus to promote the "painless" therapy aspect of ICD treatment and improve quality of life outcomes for patients.
Main objective: Compare & quantify efficacy of two different sequences of burst ATP strategies for the termination of ventricular tachycardia (with Cycle Lenght (CL) of 240ms-320ms) from baseline to 12 months post randomisation in patients who are treated with ATP -8 pulses, 88% versus patients who are treated with ATP -15 pulses, 88%
Secondary objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 8 pulses | Active Comparator | 8 pulses Anti-Tachycardia Pacing (ATP) delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT) |
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| 15 pulses | Experimental | 15 pulses Anti-Tachycardia Pacing (ATP) delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantable Cardiac Defibrillator | Device | Medtronic Marquis Family ICD, capable of Anti Tachy Pacing (ATP) for Fast Ventricular Tachycardia (FVT) via Ventricular Fibrillation (VF) zone |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Anti Tachycardia Pacing (ATP) Therapy to Terminate Fast Ventricular Tachycardia (With Cycle Length of 240ms-320msec) | Termination of Ventricular Tachycardia is calculated as percentage of successfully terminated episodes, adjusted for multiple events with (GEE) method. This technique yields an average therapy efficacy and 95% CI that is based on number of patients, number of episodes per patient, and magnitude of the correlation between responses within patients. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of ATP in Successfully Treating FVT for Patients in Primary and Secondary Prevention | one year | |
| Acceleration Rate or Degenerated Into VF of ATP for Treating FVT in the 2 Arms | one year | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maurizio Lunati, Dr. | Ospedale Niguarda Cà Granda - Milano | Principal Investigator |
| Riccardo Cappato, Dr. | Istituto Policlinico S. Donato Milanese | Principal Investigator |
| Massimo Santini, Prof. | San Filippo Neri - Roma | Principal Investigator |
| Angel Arenal, Dr. | Hospital Gregorio Marañón, Madrid | Principal Investigator |
| Josè Luis Merino, Dr. | Hospital Universitario La Paz | Principal Investigator |
| Arcadio Garcia-Alberola, Dr. | Hospital Universitario Virgen de la Arrixaca | Principal Investigator |
| Johann Mermi, Dr. | Clinic Center Dortmund | Principal Investigator |
| Pascal Defaye, Dr. | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medtronic Italia SpA | Sesto San Giovanni | MI | 20099 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17169131 | Background | Lunati M, Defaye P, Mermi J, Garcia-Alberola A, Merino JL, Arenal A, Cappato R, Navarro X, Passardi M, Santini M. Improvement of quality of life by means of antitachy pacing: from PainFREE to the ADVANCE-D Trial. Pacing Clin Electrophysiol. 2006 Dec;29 Suppl 2:S35-9. doi: 10.1111/j.1540-8159.2006.00488.x. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 8 Pulses Anti-Tachycardia Pacing (ATP) | 8 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT) |
| FG001 | 15 Pulses Anti-Tachycardia Pacing (ATP) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Percent Reduction in Shocks Delivered Per Patient for Treating FVT |
| one year |
| Compare Likelihood of Syncopal Events Associated With FVT | one year |
| Evaluate Different Possible Predictors of ATP Success | one year |
15 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 8 Pulses Anti-Tachycardia Pacing (ATP) | 8 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT) |
| BG001 | 15 Pulses Anti-Tachycardia Pacing (ATP) | 15 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Efficacy of Anti Tachycardia Pacing (ATP) Therapy to Terminate Fast Ventricular Tachycardia (With Cycle Length of 240ms-320msec) | Termination of Ventricular Tachycardia is calculated as percentage of successfully terminated episodes, adjusted for multiple events with (GEE) method. This technique yields an average therapy efficacy and 95% CI that is based on number of patients, number of episodes per patient, and magnitude of the correlation between responses within patients. | 934 patients were created in the electronic data capture system, only 925 patients were enrolled in the study: 4 patients in the 8 pulses arm and 5 patients in the 15 pulses arm were created by mistake and excluded from analysis. The analysis were performed with the Intention To Treat (ITT) method. | Posted | Number | Percentage of FVT episodes terminated | one year |
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| Secondary | Efficacy of ATP in Successfully Treating FVT for Patients in Primary and Secondary Prevention | Not Posted | one year | Participants | |||||||||||||||||||||||||||||||||||
| Secondary | Acceleration Rate or Degenerated Into VF of ATP for Treating FVT in the 2 Arms | Not Posted | one year | Participants | |||||||||||||||||||||||||||||||||||
| Secondary | Percent Reduction in Shocks Delivered Per Patient for Treating FVT | Not Posted | one year | Participants | |||||||||||||||||||||||||||||||||||
| Secondary | Compare Likelihood of Syncopal Events Associated With FVT | Not Posted | one year | Participants | |||||||||||||||||||||||||||||||||||
| Secondary | Evaluate Different Possible Predictors of ATP Success | Not Posted | one year | Participants |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Manotta | Medtronic Italia S.p.A. | 003902241371 | laura.manotta@medtronic.com |
| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| D014693 | Ventricular Fibrillation |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| >=65 years |
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| Male |
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| Germany |
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| France |
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| Spain |
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| Portugal |
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| Belgium |
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| Israel |
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| United Kingdom |
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