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Restoration of Atrioventricular Synchrony Trial (RESTORE-AV)

This study has been terminated.
(Difficult subject recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01275833
First Posted: January 12, 2011
Last Update Posted: June 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boston Scientific Corporation
Results First Submitted: April 10, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition: First Degree AV Block
Intervention: Device: Cardiac resynchronization therapy-defibrillator

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Device Programming That Modifies AV Timing Cardiac resynchronization therapy-defibrillator: Device programming that modifies AV timing
Device Programming That Allows Intrinsic AV Timing. Cardiac resynchronization therapy-defibrillator: Device programming that does not modifies AV timing

Participant Flow:   Overall Study
    Device Programming That Modifies AV Timing   Device Programming That Allows Intrinsic AV Timing.
STARTED   1   1 
COMPLETED   0   0 
NOT COMPLETED   1   1 
Study terminated                1                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Device Programming Modifies AV Timing

DDD-40-BiV

Cardiac resynchronization therapy-defibrillator: Device programming that modifies AV timing

Device Programming Allows Intrinsic AV Timing. VVI-40-RV
Total Total of all reporting groups

Baseline Measures
   Device Programming Modifies AV Timing   Device Programming Allows Intrinsic AV Timing.   Total 
Overall Participants Analyzed 
[Units: Participants]
 1   1   2 
Age 
[Units: Participants]
Count of Participants
     
<=18 years   0   0   0 
Between 18 and 65 years   0   0   0 
>=65 years   1   1   2 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      1 100.0%      0   0.0%      1  50.0% 
Male      0   0.0%      1 100.0%      1  50.0% 
Region of Enrollment 
[Units: Participants]
     
United States   1   1   2 


  Outcome Measures

1.  Primary:   Range Finding of Functional and Hemodynamic Changes Using Echocardiographic Determined Measures.   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination leading to small number of patients analyzed. As the study was stopped early, the primary objective is underpowered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Elke Sommerijns
Organization: Boston Scientific
phone: +32479767156
e-mail: elke.sommerijns@bsci.com



Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01275833     History of Changes
Other Study ID Numbers: RESTORE AV
First Submitted: January 2, 2011
First Posted: January 12, 2011
Results First Submitted: April 10, 2017
Results First Posted: June 26, 2017
Last Update Posted: June 26, 2017