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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BiV | Experimental | ATP therapies are delivered in both the ventricles |
|
| RV | Active Comparator | ATP delivered only in the right ventricle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantable Cardiac Defibrillator | Device | Implantable cardiac defibrillator with programmable Fast Ventricular tachycardia detection (FVT) window |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Anti Tachycardia Pacing (ATP) Therapy (Burst, 8 Pulses, 88 %, 1 Sequence) to Terminate All Types of Ventricular Tachycardia. | 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 |
|---|---|---|
| Compare Efficacy of the First BiV and RV ATP to Terminate FVT | one year | |
| Compare Efficacy of the First BiV and RV ATP to Terminate Slow VT | one year | |
| Compare Efficacy of BiV and RV ATP (All ATP Therapies) to Terminate Slow VT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maurizio Gasparini, Dr. | Istituto Clinico Humanitas Mirasole SpA | Principal Investigator |
| Mario Bocchiardo, Dr. | Ospedale Civile di Asti | Principal Investigator |
| Antonio Curnis, Dr. | Spedali Civili di Brescia | Principal Investigator |
| Rafael Peinado, Dr. | La Paz Madrid | Principal Investigator |
| Philippe Mabo, Prof. | Rennes University Hospital | Principal Investigator |
| Thomas Lavergne, Dr. | E. H. Pompidou - Paris | Principal Investigator |
| Frederic Anselme, Dr. | University Hospital, Rouen | Principal Investigator |
| Joerg Schwab, Dr. | University Clinic - Bonn | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medtronic Italia SpA | Sesto San Giovanni | Milan | 20099 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16684023 | Background | Schwab JO, Gasparini M, Anselme F, Mabo P, Peinado R, Lavergne T, Bocchiardo M, Mascioli G, Passardi M, Mainardis M. Right ventricular versus biventricular antitachycardia pacing in the termination of ventricular tachyarrhythmia in patients receiving cardiac resynchronization therapy: the ADVANCE CRT-D trial. J Cardiovasc Electrophysiol. 2006 May;17(5):504-7. doi: 10.1111/j.1540-8167.2006.00433.x. | |
| 34392257 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Right Ventricle (RV) | Anti Tachyarrhythmia Pacing (ATP) therapies are delivered in the right ventricle |
| FG001 | Biventricular (BiV) | Anti Tachyarrhythmia Pacing (ATP) are delivered in both ventricles |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| one year |
| Determine the Rate of Both FVT and VT Episodes Which Are Accelerated or Degenerates Into VF | one year |
| Derived |
| Landolina M, Boriani G, Biffi M, Cattafi G, Capucci A, Dello Russo A, Facchin D, Rordorf R, Sagone A, Del Greco M, Morani G, Nicolis D, Meloni S, Grammatico A, Gasparini M. Determinants of worse prognosis in patients with cardiac resynchronization therapy defibrillators. Are ventricular arrhythmias an adjunctive risk factor? J Cardiovasc Med (Hagerstown). 2022 Jan 1;23(1):42-48. doi: 10.2459/JCM.0000000000001236. |
| 29251799 | Derived | Gasparini M, Kloppe A, Lunati M, Anselme F, Landolina M, Martinez-Ferrer JB, Proclemer A, Morani G, Biffi M, Ricci R, Rordorf R, Mangoni L, Manotta L, Grammatico A, Leyva F, Boriani G. Atrioventricular junction ablation in patients with atrial fibrillation treated with cardiac resynchronization therapy: positive impact on ventricular arrhythmias, implantable cardioverter-defibrillator therapies and hospitalizations. Eur J Heart Fail. 2018 Oct;20(10):1472-1481. doi: 10.1002/ejhf.1117. Epub 2017 Dec 18. |
| 20569728 | Derived | Gasparini M, Anselme F, Clementy J, Santini M, Martinez-Ferrer J, De Santo T, Santi E, Schwab JO; ADVANCE CRT-D Investigators. BIVentricular versus right ventricular antitachycardia pacing to terminate ventricular tachyarrhythmias in patients receiving cardiac resynchronization therapy: the ADVANCE CRT-D Trial. Am Heart J. 2010 Jun;159(6):1116-1123.e2. doi: 10.1016/j.ahj.2010.02.007. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Right Ventricle (RV) | Anti Tachyarrhythmia Pacing (ATP) therapies are delivered in the right ventricle |
| BG001 | Biventricular (BiV) | Anti Tachyarrhythmia Pacing (ATP) are delivered in both ventricles |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| 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 (Burst, 8 Pulses, 88 %, 1 Sequence) to Terminate All Types of Ventricular Tachycardia. | 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. | Posted | Number | Percent of VT episodes terminated | one year |
|
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| ||||||||||||||||||||||||||||||
| Secondary | Compare Efficacy of the First BiV and RV ATP to Terminate FVT | Not Posted | one year | Participants | |||||||||||||||||||||||||||||||||||
| Secondary | Compare Efficacy of the First BiV and RV ATP to Terminate Slow VT | Not Posted | one year | Participants | |||||||||||||||||||||||||||||||||||
| Secondary | Compare Efficacy of BiV and RV ATP (All ATP Therapies) to Terminate Slow VT | Not Posted | one year | Participants | |||||||||||||||||||||||||||||||||||
| Secondary | Determine the Rate of Both FVT and VT Episodes Which Are Accelerated or Degenerates Into VF | Not Posted | one year | Participants |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elisabetta Santi | Medtronic | 003906328141 | elisabetta.santi@medtronic.com |
| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| D014693 | Ventricular Fibrillation |
| D013610 | Tachycardia |
| ID | Term |
|---|---|
| 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 |
|
| Male |
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| France |
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| Germany |
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| Spain |
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| Israel |
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| Portugal |
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| United Kingdom |
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