Restoration of Atrioventricular Synchrony Trial (RESTORE-AV)
This study has been terminated.
(Difficult subject recruitment)
Sponsor:
Boston Scientific Corporation
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Detailed Description:
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 |
Resource links provided by NLM:
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:
|
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
More Information
No publications provided
Keywords provided by Boston Scientific Corporation:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 18, 2012
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. |
Additional relevant MeSH terms:
Atrioventricular Block Heart Block Arrhythmias, Cardiac |
Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on October 18, 2012