TerminatedNCT01275833RESTORE-AVUpdated Jun 26, 2017Results posted

Restoration of Atrioventricular Synchrony Trial

An interventional study of Cardiac resynchronization therapy-defibrillator in First Degree AV Block, sponsored by Boston Scientific Corporation. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-26.

Sponsored by Boston Scientific Corporation · Not applicable, Interventional, and Other

Why this study was terminated

Difficult subject recruitment

Phase: Not applicable
Study type: Interventional
Enrollment: 2
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the detailed description

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Conditions studied

First Degree AV Block

Keywords

Implantable ICD
First Degree AV block

In context

Lead sponsor

Boston Scientific Corporation is the lead sponsor of 527 studies on the registry; 40 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

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Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 design

Phase: Not applicable
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 2 participants (actual)

Study arms

Experimental
Device programming modifies AV timing
DDD-40-BiV
Device: Cardiac resynchronization therapy-defibrillator
No intervention
Device programming allows intrinsic AV timing.
VVI-40-RV

Interventions

DeviceCardiac resynchronization therapy-defibrillator
Device programming that modifies AV timing
Also known as: First degree AV block, Long PR interval

What researchers measure

Primary outcomes

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.
Time frame: 6 months

Results

Posted Jun 26, 2017

Limitations and caveats

Early termination leading to small number of patients analyzed. As the study was stopped early, the primary objective is underpowered.

Participant flow

Participant flow — Overall Study
Milestone	Device Programming That Modifies AV Timing	Device Programming That Allows Intrinsic AV Timing.
Started	1	1
Completed	0	0
Not completed	1	1
Withdrew: Study terminated	1	1

Outcome measures

PrimaryRange 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.

Time frame:: 6 months

Range Finding of Functional and Hemodynamic Changes Using Echocardiographic Determined Measures.
Measure	Device Programming That Modifies AV Timing	Device Programming That Allows Intrinsic AV Timing.
Range Finding of Functional and Hemodynamic Changes Using Echocardiographic Determined Measures.	0	0

Adverse events

Collected over Adverse events were reported as of ICF signature, and were supposed to be collected until the 12-month follow-up visit. However, the study was terminated early (1 subject had a 6-month follow-up visit, the second subject did not have a 6-month follw-up visit).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Device Programming That Modifies AV Timing	0/1 (0%)	1/1 (100%)	1/1 (100%)
Device Programming That Allows Intrinsic AV Timing.	0/1 (0%)	0/1 (0%)	1/1 (100%)

Most frequent serious events

Most frequent serious events
Event	Device Programming That Modifies AV Timing	Device Programming That Allows Intrinsic AV Timing.
Sarcoidosis induced cardiomyopathyCardiac disorders	1/1	0/1
Cataract surgeryEye disorders	0/1	0/1

Most frequent other events

Most frequent other events
Event	Device Programming That Modifies AV Timing	Device Programming That Allows Intrinsic AV Timing.
Prolonged hospitalization due to sarcoidosis induced cardiomyopathyCardiac disorders	1/1	0/1
Ventricular tachycardiaCardiac disorders	1/1	0/1
DizzinessEar and labyrinth disorders	0/1	1/1
Non-sustained ventricular tachycardiaCardiac disorders	0/1	1/1

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Device Programming Modifies AV Timing	Device Programming Allows Intrinsic AV Timing.	Total
<=18 years	0	0	0
Between 18 and 65 years	0	0	0
>=65 years	1	1	2

Sex: Female, Male
Sex: Female, Male(Participants)	Device Programming Modifies AV Timing	Device Programming Allows Intrinsic AV Timing.	Total
Female	1	0	1
Male	0	1	1

Region of Enrollment
Region of Enrollment(participants)	Device Programming Modifies AV Timing	Device Programming Allows Intrinsic AV Timing.	Total
United States	1	1	2

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01275833
Lead sponsor: Boston Scientific Corporation
Responsible party: Sponsor
First posted: Jan 12, 2011
Start date: Jul 2011
Primary completion: Jan 2012
Completion: Jan 2012
Results posted: Jun 26, 2017
Last update: Jun 26, 2017

Study contacts

Brian Olshansky, MD

principal investigator · University of Iowa Hospitals

John Day, MD

principal investigator · Intermountain Health Care, Inc.

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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