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NCT02485093 Clinical Trial

To Pace or Not to Pace in Sinus Node Disease

Sinus Node Disease Clinical Trial

— OPTIMIST  

Official title:
Comparison of Ventricular Septal Pacing With Optimized Atrioventricular (AV) Delay to no Pacing in Sinus Node Disease (SND) Patients.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02485093
Other study ID # 2008-A01266-49
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2009
Est. completion date October 2014

Study information
Verified date February 2019
Source Abbott Medical Devices
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Optimal pacing strategy for patients with SND is still unknown, although several publications in the past years demonstrated a deleterious effect of ventricular pacing. However, pacing has always been apical in these trials, and to which extent this absence of pacing is beneficial for patients with very long PR intervals is still to be found.

The aim of this study is to compare ventricular septal pacing to no pacing in patients with SND.

Recruitment information / eligibility
Status Completed
Enrollment 215
Est. completion date October 2014
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with sinus node disease

Exclusion Criteria:

- Complete or high degree AV block

- Permanent atrial fibrillation

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Septal ventricular pacing
Ventricular pacing must be at least 90%, from the septum and with optimized AV delay
• VIP
Ventricular pacing must be less than 10%.

Locations
Country Name City State
France CHU Pontchaillou - CCP Rennes

Sponsors (1)
Lead Sponsor Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Left Ventricular Endsystolic Diameter (LVED) 18 months
Secondary AF incidence 18 months
Secondary Hospitalizations 18 months
See also
  Status Clinical Trial Phase
Terminated NCT02579889 - Clinical Benefits of the Closed Loop Stimulation in Sinus Node Disease N/A
Completed NCT01441583 - Ingenio Device Algorithm Study N/A
Completed NCT02034526 - Reducing Atrial Pacing Rate to Reduce Atrial Fibrillation in Patients With Sick Sinus Syndrome. N/A
Recruiting NCT05367037 - Physiological Ventricular Pacing Vs Managed Ventricular Pacing for Persistent AF Prevention in Prolonged AV Interval N/A
Completed NCT02400983 - Real Life Automatic Atrial Capture Device Control N/A
Completed NCT00832260 - IES-ACap: Influence of Atrial Pulse Width in the Behaviour of ACap™ Confirm Algorithm.
Completed NCT00382525 - PANORAMA Observational Study N/A