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Restoration of Atrioventricular Synchrony Trial (RESTORE-AV)

This study has been terminated.
(Difficult subject recruitment)
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01275833
First received: January 2, 2011
Last updated: April 3, 2012
Last verified: April 2012
  Purpose

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 Intervention
First Degree AV Block
Device: Cardiac resynchronization therapy-defibrillator

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Official Title: Restoration of Atrioventricular Synchrony Trial

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Range finding of functional and hemodynamic changes using echocardiographic determined measures. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Echocardiographic measures will include, but not be limited to, left ventricular volumes, left ventricular diameters, and ejection fraction.


Enrollment: 2
Study Start Date: July 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Device programming that 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 that allows intrinsic AV timing.

Detailed Description:

Same as above.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01275833

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

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01275833     History of Changes
Other Study ID Numbers: RESTORE AV
Study First Received: January 2, 2011
Last Updated: April 3, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston Scientific Corporation:
Implantable cardioverter-defibrillator (ICD) indicated patients
First Degree AV block.

ClinicalTrials.gov processed this record on November 24, 2014