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Trial record 39 of 62 for:    "Sick Sinus Syndrome"

To Pace or Not to Pace in Sinus Node Disease (OPTIMIST)

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ClinicalTrials.gov Identifier: NCT02485093
Recruitment Status : Completed
First Posted : June 30, 2015
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief 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.


Condition or disease Intervention/treatment Phase
Sinus Node Disease Device: Septal ventricular pacing Device: VIP Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 215 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of Ventricular Septal Pacing With Optimized Atrioventricular (AV) Delay to no Pacing in Sinus Node Disease (SND) Patients.
Study Start Date : June 2009
Actual Primary Completion Date : July 2013
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: No pacing
Ventricular intrinsic conduction enhanced
Device: VIP
Ventricular pacing must be less than 10%.

Experimental: Pacing
Septal ventricular pacing with optimized AV delay
Device: Septal ventricular pacing
Ventricular pacing must be at least 90%, from the septum and with optimized AV delay




Primary Outcome Measures :
  1. Left Ventricular Endsystolic Diameter (LVED) [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. AF incidence [ Time Frame: 18 months ]
  2. Hospitalizations [ Time Frame: 18 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with sinus node disease

Exclusion Criteria:

  • Complete or high degree AV block
  • Permanent atrial fibrillation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02485093


Locations
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France
CHU Pontchaillou - CCP
Rennes, France, 35000
Sponsors and Collaborators
Abbott Medical Devices

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02485093     History of Changes
Other Study ID Numbers: 2008-A01266-49
First Posted: June 30, 2015    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
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Sick Sinus Syndrome
Arrhythmia, Sinus
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Heart Block
Cardiac Conduction System Disease
Pathologic Processes