Heart FailureCAPTIVATENCT02097290

Evaluation of Automatic Threshold Algorithms

A study testing CRT-D in people with Heart Failure, run by Boston Scientific Corporation at 36 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study will evaluate the PaceSafe Right Ventricular Autothreshold (RVAT) and Left Ventricular Autothreshold (LVAT) features for AUTOGEN Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Heart Failure
What is being tested?: CRT-D
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 216 participants
Where: 36 sitesUnited States
Study dates: Apr 2014to May 2017
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

Subjects prescribed a CRT-D and indicated per guidelines, who will receive an AUTOGEN CRT-D model G160, G161, G172, G173
Subjects who have an implanted functional endocardial right ventricular defibrillation lead or who will receive a endocardial right ventricular defibrillation lead
Subjects who have an implanted functional bipolar or unipolar left ventricular lead or who will receive a bipolar or unipolar left ventricular lead
Subjects who are willing and capable of providing informed consent to undergo a device implant procedure, and to participate in all testing and follow-ups defined in this protocol
Subjects whose age is 18 or above, or of legal age to give informed consent specific to national law

Who cannot join

Subjects who have an implanted multipolar (>2poles) left ventricular lead or who will receive a multipolar (>2poles) left ventricular lead
Subjects with an unknown model/manufacturer, or implant date for the RA, RV or LV lead
Subjects for whom a RV defibrillation lead manufactured by St. Jude Medical or Biotronik is implanted, is planned to be implanted, or has been abandoned
Implanted with an active Medtronic Sprint Fidelis® lead models: 6930, 6931, 6948 or 6949
Subjects with an implanted or abandoned St. Jude Medical QuickSite® or QuickFlex® lead models: 1056T, 1058T, 1156T, 1158T
Subjects with a RV or LV lead revision or extraction within 30 days of enrollment

Show all 15Show fewer

Subjects with an implanted lead that is planned to be extracted during the study implant procedure
Subjects with an active implanted RA or RV lead that is greater than 10 years old, unless the lead will be abandoned
Subjects with an active implanted LV lead that is greater than 8 years old, unless the lead will be abandoned
Subjects preexisting unipolar pacemaker that will not be explanted/abandoned
Subjects with a life expectancy less than 6 months
Subjects with a prosthetic mechanical tricuspid heart valve
Women of childbearing age who are pregnant or plan to become pregnant. NOTE: women of childbearing potential with an uncertain pregnancy status must have a negative pregnancy test within 7 days prior to enrollment. Pregnancy tests are required as part of standard routing clinical practice at all centers whenever female patients are exposed to x-ray radiation. Since this protocol does not require any exposure of the female patients to x-ray and x-ray exposure is part of the clinical procedure, it is the responsibility of the investigators to ensure that pregnant females will not be exposed to x-ray at any time
Subject enrolled in a concurrent study, except national/governmental registries that do not require a signed informed consent form, without the written approval from Boston Scientific
Subjects who are not geographically stable, to the extent that it would prevent attending the study follow-ups at the investigational center

Trial locations and contacts

36 sites in 1 country.

City, postcode or hospital

36 sites in 1 country

United States36 sites

Summa Health System
Akron, Ohio, 44034
Delray Medical Center
Atlantis, Florida, 33462
Seton Medical Center
Austin, Texas, 78705
University of Maryland Medical System
Baltimore, Maryland, 21201
Steward St. Elizabeth's Medical Center of Boston, Inc.
Boston, Massachusetts, 02135
St. Luke's Hospital
Cedar Rapids, Iowa, 52043
Lindner Center for Research and Education
Cincinnati, Ohio, 45219
Danbury Hospital
Danbury, Connecticut, 06810
University of Iowa Hospitals and Clinics
Davenport, Iowa, 52803
St. John Hospital & Medical Center
Detroit, Michigan, 48236
Glendale Adventist Medical Center
Glendale, California, 91204
University Medical Center-Greenville Memorial Hospital
Greenville, South Carolina, 29605
St. Mary's Medical Center
Huntington, West Virginia, 25702
St. Vincent's Medical Center
Jacksonville, Florida, 32204
Baptist Medical Center
Jacksonville, Florida, 32207
First Coast Cardiovascular
Jacksonville, Florida, 32216
IU Health LaPorte
La Porte, Indiana, 46350
Sparrow Health System
Lansing, Michigan, 48912
Good Samaritan Hospital
Lebanon, Pennsylvania, 17042
Norton Cardiovascular Associates
Louisville, Kentucky, 40205
St. Patrick Hospital
Missoula, Montana, 59802
Orlando Regional Medical Center
Orlando, Florida, 32806
St. Elizabeth Health Center
Poland, Ohio, 44514
Wake Medical Center
Raleigh, North Carolina, 27610
Virginia Commonwealth University Health
Richmond, Virginia, 23298
Rochester General Hospital
Rochester, New York, 14621
University of Utah Hospital and Clinics
Salt Lake City, Utah, 84132
Cardiology Clinic of San Antonio
San Antonio, Texas, 78229
Cox Health
Springfield, Missouri, 65807
University Community Hospital
Trinity, Florida, 34655
North Mississippi Medical Center
Tupelo, Mississippi, 38801
Carle Foundation Hospital
Urbana, Illinois, 61801
PeaceHealth Southwest Medical
Vancouver, Washington, 98664
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Via-Christi Regional Medical Center
Wichita, Kansas, 67208
Winter Haven Hospital
Winter Haven, Florida, 33881

Other trials in United States

About this study

Official title: CAPTure Information Via Automatic Threshold Evaluation

Read the detailed description

The objective of the CAPTIVATE Clinical Study is to gather data to establish the safety and effectiveness of the PaceSafe Right Ventricular Autothreshold (RVAT) and Left Ventricular Autothreshold (LVAT) features to support the regulatory approval of the AUTOGEN CRT-D family of devices.

Conditions: Heart Failure
Being tested: CRT-D
Keywords: Threshold algorithms, CRT-D
Medical subject headings: Heart Failure

What participants receive

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

CRT-DDevice
For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated

Study groups in NCT02097290
Study group	Role	What they receive
CRT-D	Experimental	For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated Receives: Device: CRT-D

What is being measured

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

Primary Safety Endpoint is to Evaluate the System-related Complication-free Rate
Safety of the AUTOGEN was evaluated by the system-related complication-free rate (CFR) at 3-months post-implant. The system consists of the implanted AUTOGEN CRT-D pulse generator, RA lead (if implanted), RV lead, and LV lead.
Measured: 3 months
The Accuracy of the RVAT Commanded Test Will be Evaluated by Comparing the RVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold.
Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The RVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate commanded threshold is defined by: |commanded threshold - core lab determined threshold| ≤ 0.2 V; if the commanded threshold is ≤ 3.5V or |commanded threshold - core lab determined threshold| ≤ 0.5 V; if the commanded threshold is > 3.5V. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis.
Measured: 1-month and 3-month follow-up visits
The Accuracy of the LVAT Commanded Test Will be Evaluated by Comparing the LVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold.
Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The LVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate commanded threshold is defined by: commanded threshold - core lab determined threshold| ≤ 0.2 V; if the commanded threshold is ≤ 3.5V or |commanded threshold - core lab determined threshold| ≤ 0.5 V; if the commanded threshold is > 3.5V. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis.
Measured: 1-month and 3-month follow up visits
The Accuracy of the RVAT Ambulatory Test Will be Evaluated by Comparing the RVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold
Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits.The RVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate Ambulatory threshold is defined by:|Ambulatory threshold - ECG threshold| ≤ 0.6 V; if the ECG threshold is ≤ 3.5V or |Ambulatory threshold - ECG threshold| ≤ 1.0 V; if the ECG threshold is > 3.5V. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets form the 1-month and 3-month visits were pooled for purposes of endpoint analysis.
Measured: 1-month and 3-month follow up visits
The Accuracy of the LVAT Ambulatory Test Will be Evaluated by Comparing the LVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold
Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The LVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate Ambulatory threshold is defined by: |Ambulatory threshold - ECG threshold| ≤ 1.0 V. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets form the 1-month and 3-month visits were pooled for purposes of endpoint analysis.
Measured: 1-month and 3-month follow up visits

Secondary outcomes (2)

RVAT Secondary Efficacy Endpoint: The Percent of RVAT Commanded Tests That Result in an Appropriate Outcome
This endpoint will evaluate the percent of RVAT commanded tests that result in an appropriate outcome. There are three possible outcomes to a commanded test:
1. A device-determined threshold
2. A threshold test code (indicating that a threshold could not be determined) representing an error condition that is beyond the control of the RVAT feature and could occur in the manual threshold tests
3. A threshold test code (indicating that a threshold could not be determined) that was due to a limitation of the RVAT feature and might not occur in manual threshold tests An appropriate RVAT outcome consists of the first two outcomes listed above: a device-determined threshold and a threshold test code representing an error condition that is beyond the control of the RVAT feature and could occur in the manual threshold tests. An inappropriate RVAT outcome consists of the last of the three outcomes listed above.
Measured: 3-month follow up visit
LVAT Secondary Efficacy Endpoint: The Percent of LVAT Commanded Tests That Result in an Appropriate Outcome
This endpoint will evaluate the percent of LVAT commanded tests that result in an appropriate outcome. There are three possible outcomes to a commanded test:
1. A device-determined threshold
2. A threshold test code (indicating that a threshold could not be determined) representing an error condition that is beyond the control of the LVAT feature and could occur in the manual threshold tests
3. A threshold test code (indicating that a threshold could not be determined) that was due to a limitation of the LVAT feature and might not occur in manual threshold tests An appropriate LVAT outcome consists of the first two outcomes listed above: a device-determined threshold and a threshold test code representing an error condition that is beyond the control of the LVAT feature and could occur in the manual threshold tests. An inappropriate LVAT outcome consists of the last of the three outcomes listed above.
Measured: 3-month follow up visit

Timeline

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

Apr 2014May 2017

First posted27 Mar 2014 (estimated)
Study startApr 2014
Primary completionJan 2016
Study completionMay 2017

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Heart FailureStudies 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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 216 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02097290
Sponsor's protocol ID: CAPTIVATE
Other IDs: IDE# G130241
Acronym: CAPTIVATE
Status last verified: Jan 2018
First submitted: 20 Mar 2014
Last updated: 19 Apr 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Friedman DJ, Burr J, Jones PW, Wold N. Automatic Threshold Function With Left Bundle Branch Area Versus Traditional Right Ventricular Lead Placement. J Cardiovasc Electrophysiol. 2025 Jun;36(6):1419-1422. doi: 10.1111/jce.16696. Epub 2025 Apr 28.
PubMed 40296252

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CAPTure Information Via Automatic Threshold Evaluation
ClinicalTrials.gov ID: NCT02097290
Acronym / sponsor ID: CAPTIVATE / CAPTIVATE
Conditions: Heart Failure
Keywords: Threshold algorithms, CRT-D
Study type: Interventional
Recruitment status: Completed
Enrolment: 216 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: Apr 2014 (actual)
Primary completion: Jan 2016 (actual)
Study completion: May 2017 (actual)
First posted: 27 Mar 2014 (estimated)
Results: Posted 1 Sep 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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
CRT-D	Experimental	Device: CRT-DFor all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated

Who may qualify

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

Key inclusion criteria (5 listed)

Subjects prescribed a CRT-D and indicated per guidelines, who will receive an AUTOGEN CRT-D model G160, G161, G172, G173
Subjects who have an implanted functional endocardial right ventricular defibrillation lead or who will receive a endocardial right ventricular defibrillation lead
Subjects who have an implanted functional bipolar or unipolar left ventricular lead or who will receive a bipolar or unipolar left ventricular lead
Subjects who are willing and capable of providing informed consent to undergo a device implant procedure, and to participate in all testing and follow-ups defined in this protocol
Subjects whose age is 18 or above, or of legal age to give informed consent specific to national law

Key exclusion criteria (15 listed)

Subjects who have an implanted multipolar (>2poles) left ventricular lead or who will receive a multipolar (>2poles) left ventricular lead
Subjects with an unknown model/manufacturer, or implant date for the RA, RV or LV lead
Subjects for whom a RV defibrillation lead manufactured by St. Jude Medical or Biotronik is implanted, is planned to be implanted, or has been abandoned
Implanted with an active Medtronic Sprint Fidelis® lead models: 6930, 6931, 6948 or 6949
Subjects with an implanted or abandoned St. Jude Medical QuickSite® or QuickFlex® lead models: 1056T, 1058T, 1156T, 1158T

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
CRT-DFor all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated	Device	CRT-D

Primary outcome

Primary Safety Endpoint is to Evaluate the System-related Complication-free Rate
Time frame: 3 months
Safety of the AUTOGEN was evaluated by the system-related complication-free rate (CFR) at 3-months post-implant. The system consists of the implanted AUTOGEN CRT-D pulse generator, RA lead (if implanted), RV lead, and LV lead.
The Accuracy of the RVAT Commanded Test Will be Evaluated by Comparing the RVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold.
Time frame: 1-month and 3-month follow-up visits
Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The RVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate commanded threshold is defined by: |commanded threshold - core lab determined threshold| ≤ 0.2 V; if the commanded threshold is ≤ 3.5V or |commanded threshold - core lab determined threshold| ≤ 0.5 V; if the commanded threshold is > 3.5V. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis.
The Accuracy of the LVAT Commanded Test Will be Evaluated by Comparing the LVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold.
Time frame: 1-month and 3-month follow up visits
Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The LVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate commanded threshold is defined by: commanded threshold - core lab determined threshold| ≤ 0.2 V; if the commanded threshold is ≤ 3.5V or |commanded threshold - core lab determined threshold| ≤ 0.5 V; if the commanded threshold is > 3.5V. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis.
The Accuracy of the RVAT Ambulatory Test Will be Evaluated by Comparing the RVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold
Time frame: 1-month and 3-month follow up visits
Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits.The RVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate Ambulatory threshold is defined by:|Ambulatory threshold - ECG threshold| ≤ 0.6 V; if the ECG threshold is ≤ 3.5V or |Ambulatory threshold - ECG threshold| ≤ 1.0 V; if the ECG threshold is > 3.5V. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets form the 1-month and 3-month visits were pooled for purposes of endpoint analysis.
The Accuracy of the LVAT Ambulatory Test Will be Evaluated by Comparing the LVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold
Time frame: 1-month and 3-month follow up visits
Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The LVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate Ambulatory threshold is defined by: |Ambulatory threshold - ECG threshold| ≤ 1.0 V. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets form the 1-month and 3-month visits were pooled for purposes of endpoint analysis.

2 secondary outcomes

RVAT Secondary Efficacy Endpoint: The Percent of RVAT Commanded Tests That Result in an Appropriate Outcome
Time frame: 3-month follow up visit
LVAT Secondary Efficacy Endpoint: The Percent of LVAT Commanded Tests That Result in an Appropriate Outcome
Time frame: 3-month follow up visit

Results and safety

Results posted to the registry on 1 Sep 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
CRT-D	210	193

Primary outcome: Primary Safety Endpoint is to Evaluate the System-related Complication-free Rate

Time frame: 3 months. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	CRT-D n = 210
Value	84.2 (79.5 to NA)

Population analysed: Implant + Attempt Subjects

Primary outcome: The Accuracy of the RVAT Commanded Test Will be Evaluated by Comparing the RVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold.

Time frame: 1-month and 3-month follow-up visits. Number (95% Confidence Interval). Unit: percentage of commanded RVAT thresholds

Measure	CRT-D n = 171
Value	97.9 (95.9 to NA)

Population analysed: A total of 288 paired datasets (from 171 unique subjects in whom RVAT threshold was available), each dataset consisting of a commanded RVAT threshold and a core lab determined threshold, were collected at the 1-month and 3- month visits and pooled for final analysis.

Primary outcome: The Accuracy of the LVAT Commanded Test Will be Evaluated by Comparing the LVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold.

Time frame: 1-month and 3-month follow up visits. Number (95% Confidence Interval). Unit: Percentage of commanded LVAT thresholds

Measure	CRT-D n = 182
Value	97.8 (96.0 to NA)

Population analysed: A total of 324 paired datasets (from 182 unique subjects in whom LVAT threshold was available), each dataset consisting of a commanded LVAT threshold and a core lab determined threshold, were collected at the 1-month and 3- month visits and pooled for final analysis.

Primary outcome: The Accuracy of the RVAT Ambulatory Test Will be Evaluated by Comparing the RVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold

Time frame: 1-month and 3-month follow up visits. Number (95% Confidence Interval). Unit: Percentage of RVAT ambulatory thresholds

Measure	CRT-D n = 183
Value	99.0 (97.5 to NA)

Population analysed: A total of 314 paired datasets (from 183 unique subjects in whom RVAT threshold was available), each dataset consisting of an ambulatory RVAT threshold and a core lab determined threshold, were collected at the 1-month and 3- month visits and pooled for final analysis.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events reported were collected from ICF signature until the last study follow-up.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CRT-D	101 of 210 (48.1%)	81 of 210 (38.6%)	17 of 210

Limitations and caveats (from the sponsor): The RVAT and LVAT endpoints are compared against a performance goal rather than to a randomized control arm.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40296252Friedman DJ, Burr J, Jones PW, Wold N. Automatic Threshold Function With Left Bundle Branch Area Versus Traditional Right Ventricular Lead Placement. J Cardiovasc Electrophysiol. 2025 Jun;36(6):1419-1422. doi: 10.1111/jce.16696. Epub 2025 Apr 28.

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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.

Kenneth Ellenbogen, MD principal investigator

Virginia Commonwealth University Medical Center

36 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CRT-D in people with Heart Failure, run by Boston Scientific Corporation at 36 sites in United States.

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 5 inclusion and 15 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: finished, as of the sponsor's last update on 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 1 Sep 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?

Primary Safety Endpoint is to Evaluate the System-related Complication-free Rate (time frame: 3 months). The study lists 5 primary outcomes in all. 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 NCT02097290, which also lists 1 linked publication.

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 19 Apr 2018.