Restoration of Atrioventricular Synchrony Trial (RESTORE-AV)

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. Identifier: NCT01275833
Recruitment Status : Terminated (Difficult subject recruitment)
First Posted : January 12, 2011
Results First Posted : June 26, 2017
Last Update Posted : June 26, 2017
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
The objective of the trial is to observe the effects of restoring atrioventricular (AV) synchrony in subjects with prolonged PR intervals. This will be assessed both acutely and chronically using echocardiographic and functional measurements.

Condition or disease Intervention/treatment
First Degree AV Block Device: Cardiac resynchronization therapy-defibrillator

Detailed Description:
Same as above.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Restoration of Atrioventricular Synchrony Trial
Study Start Date : July 2011
Primary Completion Date : January 2012
Study Completion Date : January 2012

Arm Intervention/treatment
Experimental: Device programming modifies AV timing
Device: Cardiac resynchronization therapy-defibrillator
Device programming that modifies AV timing
Other Names:
  • First degree AV block
  • Long PR interval
No Intervention: Device programming allows intrinsic AV timing.

Primary Outcome Measures :
  1. Range Finding of Functional and Hemodynamic Changes Using Echocardiographic Determined Measures. [ Time Frame: 6 months ]
    Echocardiographic measures will include, but not be limited to, left ventricular volumes, left ventricular diameters, and ejection fraction.

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

Inclusion Criteria:

  • Meet current indications for an implantable cardioverter-defibrillator (ICD) implant with:
  • QRS width < 120 msec
  • Left ventricular ejection fraction (LVEF) < 35% (no more than 180 days prior to enrollment)
  • NYHA functional class II/III
  • Optimal pharmacological heart failure therapy
  • PR interval >/= 230 msec
  • Ability to tolerate protocol required programming
  • Access to a telephone line compatible with the LATITUDE® Communicator
  • Subjects in sinus rhythm at the time of the baseline visit and who are expected to remain in sinus rhythm for the duration of the study
  • Age 18 or above, or of legal age to give informed consent specific to state and national law
  • Willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigational center and return to the investigational center at the intervals defined by this protocol

Exclusion Criteria:

  • Previously placed pacemaker, ICD, or CRT device
  • Inability or refusal to sign the Informed Consent Form
  • Documented life expectancy of less than 12 months or expected to undergo heart transplant within the next 12 months
  • Have tricuspid valve disease or who are likely to receive a mechanical tricuspid valve during the course of the clinical investigation
  • Inability or refusal to comply with the follow-up schedule
  • Have a neuromuscular, orthopedic, or other noncardiac condition that prevents subject from normal unsupported walking for the six minute hall walk test
  • Have surgically uncorrected primary valvular heart disease
  • Second or third degree atrioventricular block (AVB)
  • Permanent or persistent atrial tachyarrhythmia that is refractory to all therapies
  • Have had cardiac surgery, percutaneous coronary intervention, or myocardial infarction within 3 months of signing consent or who are likely to undergo a cardiac surgery or procedure in the foreseeable future
  • Enrolled in any concurrent study unless written approval has been obtained from Boston Scientific or The Integra Group
  • Women who are pregnant or plan to become pregnant

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 identifier (NCT number): NCT01275833

Sponsors and Collaborators
Boston Scientific Corporation
Principal Investigator: Brian Olshansky, MD University of Iowa Hospitals
Principal Investigator: John Day, MD Intermountain Medical Center

Responsible Party: Boston Scientific Corporation Identifier: NCT01275833     History of Changes
Other Study ID Numbers: RESTORE AV
First Posted: January 12, 2011    Key Record Dates
Results First Posted: June 26, 2017
Last Update Posted: June 26, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Boston Scientific Corporation:
Implantable ICD
First Degree AV block

Additional relevant MeSH terms:
Atrioventricular Block
Heart Block
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes