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Temporary RV VVI pacing

Phase 2

Acute Myocardial Infarction | Unknown | Cardiovascular |Boston Scientific Corporation|Last Updated: Aug 31, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedNO_TREATMENT_CONTROLLEDBiomarker
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

Temporary RV VVI pacing · 1 trial · 1 indication

Phase 2 1
NCT00409604PROTECT : Pacing to Protect Heart for Damage From Blocked Heart Vessel and From Re-opening Blocked Vessel(s)Acute Myocardial Infarction
COMPLETED60 Analytics
PHASE2COMPLETED
PROTECT : Pacing to Protect Heart for Damage From Blocked Heart Vessel and From Re-opening Blocked Vessel(s)
Acute Myocardial InfarctionUnlock trial analytics

Study Endpoints

Primary Endpoints

Infarct size (area under the curve of creatine kinase) at baseline compared with MRI at 4 months and at 12 months
4 & 12 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALStandard PCI procedure + pacing post conditioning
2NO_INTERVENTIONStandard PCI procedure

Interventions

NameTypeDescription
Temporary RV VVI pacingDEVICEtemporary pacing at the onset of revascularisation
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Clinical diagnosis of acute myocardial infarction, requiring PCI within 2 to 6 hours following symptoms * Total occlusion of a coronary artery with reference vessel diameter \>or= 3mm Exclusion Criteria: * Thrombolitics * Severe bradycardia requiring cardiac pacing * Previou...

Countries:Netherlands
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Frequently asked questions about Temporary RV VVI pacing

What is Temporary RV VVI pacing used for in Acute Myocardial Infarction?

Temporary RV VVI pacing is an investigational cardiovascular therapy being studied for use in Acute Myocardial Infarction. It is intended to protect the heart from damage caused by a blocked heart vessel and from re-opening blocked vessels. The treatment is currently in Phase 2 clinical development.

Who makes Temporary RV VVI pacing?

Temporary RV VVI pacing is being developed by Boston Scientific Corporation, which trades under the ticker BSX. The company is conducting clinical research on this investigational therapy for Acute Myocardial Infarction.

What phase is Temporary RV VVI pacing in?

Temporary RV VVI pacing is in Phase 2 clinical development. It is an investigational therapy and has not been approved by regulatory authorities. A Phase 2 clinical trial has been completed to evaluate its use in patients with Acute Myocardial Infarction.

What clinical trials is Temporary RV VVI pacing in?

Temporary RV VVI pacing has one completed Phase 2 clinical trial registered as NCT00409604, titled PROTECT: Pacing to Protect Heart for Damage From Blocked Heart Vessel and From Re-opening Blocked Vessel(s). The trial enrolled 60 participants with Acute Myocardial Infarction in the Netherlands.

Is Temporary RV VVI pacing the same as any other drug?

Temporary RV VVI pacing is a distinct investigational therapy and no alternative names have been reported. It is being studied specifically for Acute Myocardial Infarction and is not known to be identical to any other approved or investigational drug.