Restoration of Atrioventricular Synchrony Trial

First Degree AV Block Clinical Trial

— RESTORE-AV  

Official title:

Restoration of Atrioventricular Synchrony Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01275833
• Other study ID #: RESTORE AV
• Status: Terminated
• Phase: N/A
• First received: January 2, 2011
• Last updated: June 22, 2017
• Start date: July 2011
• Est. completion date: January 2012

Study information

• Verified date: June 2017
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Same as above.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrioventricular Block
• First Degree AV Block

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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