First Degree AV BlockRESTORE-AVNCT01275833

Restoration of Atrioventricular Synchrony Trial

A study testing Cardiac resynchronization therapy-defibrillator in people with First Degree AV Block, run by Boston Scientific Corporation.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: First Degree AV Block
What is being tested?: Cardiac resynchronization therapy-defibrillator
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2 participants
Where: No sites listed yet
Study dates: Jul 2011to Jan 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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

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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

About this study

Read the detailed description

Same as above.

Conditions: First Degree AV Block
Being tested: Cardiac resynchronization therapy-defibrillator
Keywords: Implantable ICD, First Degree AV block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cardiac resynchronization therapy-defibrillatorDevice
Also called First degree AV block, Long PR interval
Device programming that modifies AV timing

Study groups in NCT01275833
Study group	Role	What they receive
Device programming modifies AV timing	Experimental	DDD-40-BiV Receives: Device: Cardiac resynchronization therapy-defibrillator
Device programming allows intrinsic AV timing.	No intervention	VVI-40-RV

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2011Jan 2012

First posted12 Jan 2011 (estimated)
Study startJul 2011
Primary completionJan 2012
Study completionJan 2012

Why it stopped: Difficult subject recruitment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for First Degree AV BlockStudies of the same condition, open and under way.
More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01275833
Sponsor's protocol ID: RESTORE AV
Acronym: RESTORE-AV
Status last verified: Jun 2017
First submitted: 2 Jan 2011
Last updated: 26 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Restoration of Atrioventricular Synchrony Trial
ClinicalTrials.gov ID: NCT01275833
Acronym / sponsor ID: RESTORE-AV / RESTORE AV
Conditions: First Degree AV Block
Keywords: Implantable ICD, First Degree AV block
Study type: Interventional
Recruitment status: TerminatedReason stopped: Difficult subject recruitment
Enrolment: 2 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: Jul 2011
Primary completion: Jan 2012 (actual)
Study completion: Jan 2012 (actual)
First posted: 12 Jan 2011 (estimated)
Results: Posted 26 Jun 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Same as above.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Device programming modifies AV timing	Experimental	Device: Cardiac resynchronization therapy-defibrillatorDDD-40-BiV
Device programming allows intrinsic AV timing.	No intervention	–VVI-40-RV

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cardiac resynchronization therapy-defibrillatorAlso: First degree AV block, Long PR intervalDevice programming that modifies AV timing	Device	Device programming modifies AV timing

Primary outcome

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

Results and safety

Results posted to the registry on 26 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Device Programming That Modifies AV Timing	1	0
Device Programming That Allows Intrinsic AV Timing.	1	0

Primary outcome: Range Finding of Functional and Hemodynamic Changes Using Echocardiographic Determined Measures.

Time frame: 6 months

Measure	Device Programming That Modifies AV Timing n = 0	Device Programming That Allows Intrinsic AV Timing. n = 0
Value	0	0

Population analysed: The study was terminated early: long PR intervals are relatively rare in this population, and it would take an inordinately long time to enroll sufficient patients. Because of the early termination of the study, no data was analyzed since the primary objective is underpowered.

Adverse events

Time frame: 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).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Device Programming That Modifies AV Timing	1 of 1 (100%)	1 of 1 (100%)	0 of 1
Device Programming That Allows Intrinsic AV Timing.	0 of 1 (0%)	1 of 1 (100%)	0 of 1

Limitations and caveats (from the sponsor): Early termination leading to small number of patients analyzed. As the study was stopped early, the primary objective is underpowered.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Brian Olshansky, MD principal investigator

University of Iowa Hospitals

John Day, MD principal investigator

Intermountain Health Care, Inc.

Questions about this trial

What is this clinical trial studying?

A study testing Cardiac resynchronization therapy-defibrillator in people with First Degree AV Block, run by Boston Scientific Corporation.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Range Finding of Functional and Hemodynamic Changes Using Echocardiographic Determined Measures. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01275833.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2017.