Status:
COMPLETED
DATAS: The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Ventricular Tachycardia
Ventricular Fibrillation
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
The Dual Chamber \& Atrial Tachyarrhythmias Adverse Events Study (DATAS) was designed to analyze the ability of dual chamber ICDs, to reduce clinically significant adverse events as compared to single...
Detailed Description
Single chamber (SC) implantable cardioverter defibrillators (ICDs) have several limitations that might be relevant during follow up, like atrial pacing requirements, inadequate therapies, sustained at...
Eligibility Criteria
Inclusion
- Meet the Class I implantation criteria for single chamber implantable cardioverter defibrillator according to the guidelines (ACC/AHA).
Exclusion
- Permanent atrial fibrillation
- Patients without structural heart disease
- Patient meets implantation criteria for dual-chamber pacing (symptomatic sinus node disease, all 2nd Atrio-Ventricular (AV) block \[except asymptomatic Mobitz I\] and all 3rd degree AV block ).
- Patient with previous system implanted (ICD or pacemaker).
- Patients with biventricular stimulation or re-synchronization.
- Patient has a mechanical right heart valve.
- Patient has medical conditions that would preclude the testing required by the protocol, or limit study participation.
- Patient is unwilling or unable to cooperate or give written informed consent, or the patient is a minor and legal guardians refuse to give informed consent.
- Patient is or will be inaccessible for follow-up at the study center.
- Patients who are enrolled or planning to enroll in other clinical trials during the clinical study.
Key Trial Info
Start Date :
November 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
354 Patients enrolled
Trial Details
Trial ID
NCT00157820
Start Date
November 1 2000
End Date
October 1 2005
Last Update
July 2 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.