Restoration of Atrioventricular Synchrony Trial (RESTORE-AV)

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.

Study Overview

• Status: Terminated
• Conditions: First Degree AV Block
• Intervention / Treatment: Device: Cardiac resynchronization therapy-defibrillator

Detailed Description

Same as above.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Device programming modifies AV timing; DDD-40-BiV	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.; VVI-40-RV

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Brian Olshansky, MD, University of Iowa Hospitals; Principal Investigator: John Day, MD, Intermountain Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (ACTUAL): January 1, 2012
• Study Completion (ACTUAL): January 1, 2012

Study Registration Dates

• First Submitted: January 2, 2011
• First Submitted That Met QC Criteria: January 11, 2011
• First Posted (ESTIMATE): January 12, 2011

Study Record Updates

• Last Update Posted (ACTUAL): June 26, 2017
• Last Update Submitted That Met QC Criteria: June 22, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Implantable ICD; First Degree AV block
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Block; Atrioventricular Block
• Other Study ID Numbers: RESTORE AV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO