Status:
COMPLETED
Comparison of AAIsafeR and DDD Modes in Non-selected Patients
Lead Sponsor:
Sorin Group Canada
Conditions:
Any Patient Who Fulfills the Inclusion Criteria to be Implanted With a Dual Chamber Pacemaker Maybe Included in the Study as Per ACC/AHA Guidelines
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
1 Purpose In patients with sinus node dysfunction (SND), the use of AAI mode is rare. In paroxysmal high-degree or complete atrio-ventricular (AV) block, paroxysmal vagally-mediated bradycardia, sing...
Detailed Description
In patients with sinus node dysfunction (SND), the use of AAI mode is rare. In paroxysmal high-degree or complete atrio-ventricular (AV) block, paroxysmal vagally-mediated bradycardia, single chamber ...
Eligibility Criteria
Inclusion
- Inclusion criteria / Indications Any patient who fulfils one or more of the official guidelines to be implanted with a dual-chamber pacemaker (primo-implantation) may be included in the study.
Exclusion
- Exclusion criteria / Contraindications
- The patients presenting with one or more of the following characteristics cannot be included:
- Permanent complete AV block
- Permanent atrial and/or ventricular arrhythmias
- already implanted with a cardioverter-defibrillator (ICD)
- Likely to have a cardiac surgery in the next six months, mainly for:
- severe coronary artery disease
- severe valvular disease
- Refuses to sign an consent form after having received the appropriate information
- Refuses to co-operate
- Not able to understand the study objectives and protocol
- Not available for scheduled follow-up
- With a life expectancy less than one year
- Already included into another clinical study competing with the objectives of the CAN-SAVE R study.
- \<18 years old.
- Contraindications Any patient to whom a contraindication from device labeling applies shall not be included in the study.
- \-
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT01219621
Start Date
April 1 2006
End Date
April 1 2009
Last Update
October 13 2010
Active Locations (10)
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1
Grey Nuns hospital
Edmonton, Alberta, Canada, T6L 5X8
2
Royal-Alex hospital
Edmonton, Alberta, Canada
3
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
4
Southlake hospital
Newmarket, Ontario, Canada