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TerminatedNCT03305393Updated Sep 19, 2019

Implementation of a Protocol Utilizing Adaptive CRT in a Normal AV Conduction, CRT Non-Response Population at Generator Replacement

An interventional study of Adaptiv CRT in Heart Failure, sponsored by Stern Cardiovascular Foundation, Inc.. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-19.

Sponsored by Stern Cardiovascular Foundation, Inc. · Not applicable, Interventional, and Treatment

Why this study was terminated
Only one subject was enrolled and that subject was Lost to Follow Up. Decision was made to terminate the study.
Phase
Not applicable
Study type
Interventional
Enrollment
1
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

IMPROVE RESPONSE is a physician initiated research study. It is a prospective, non-randomized, multi-center, post-market, U.S. Cardiac Resynchronization Therapy (CRT) in heart failure (HF) observational study. The purpose of this clinical study is to test the hypothesis that market-released CRT devices, which contain the AdaptivCRT (aCRT) algorithm have an incremental benefit in improving CRT response in a chronic CRT non responder population with left bundle branch block (LBBB) and normal atrio-ventricular (AV) condition compared to CRT devices with traditional biventricular pacing delivery methods at generator replacement.

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Conditions studied

  • Heart Failure

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Keywords

  • Heart Failure
  • CRT
  • Cardiac Recynchronization Therapy
  • left bundle branch block
  • atrio-ventricular conduction
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Who can participate

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

Inclusion criteria

  • Normal AV conduction (SAV\<220 ms or PAV\<270 MS)
  • Left Bundle Branch Block (defined as > or = to 140 ms (male) or > or = 130 (female), QR or rS in leads V1 and V2, and Mid QRS notching or slurring in v 2 of leads V1, V2, V5, V6 and I and aVL.)
  • Patient and/or physician assessment or unchanged or worsened heart failure status at the time of recommended replacement time (RRT) for previous CRT device.
  • Sinus Rhythm at the time of enrollment

Exclusion criteria

Exclusion Criteria:

  • Moderate to severe Aortic Stenosis
  • Moderate to severe Mitral Regurgitation
  • Patient age \<18 years old
  • AF burden >15%
  • Severe pulmonary disease requiring supplemental oxygen use
  • ESRD
  • System Modification at RRT Generator Changeout
  • AdaptivCRT prior to enrollment
  • Expected patient longevity \< 1 year
  • Persistant or chronic atrial fibriliation
  • Women who are pregnant or who plan to become pregnant during the clinical trial
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1 participant (actual)

Study arms

  • Other
    Adaptiv CRT

    Adaptiv CRT algorithm in Medtronic FDA approved CRT devices to be programmed as ON at 6 month follow-up visit

    Device: Adaptiv CRT

Interventions

  • DeviceAdaptiv CRT

    Adaptiv CRT algorithm to be programmed to ON in CRT devices of study patients at 6 month follow-up visit

05

What researchers measure

Primary outcomes

  1. Ejection fraction

    Change in ejection fraction as determined by echocardiography 6 months following the addition of adaptive CRT as compared to the same end points following patient management optimization

    Time frame: 12 Months

  2. NYHA functional class

    Change in NYHA functional class 6 months following the addition of adaptive CRT as compared to the same end points following patient management optimization

    Time frame: 12 months

Secondary outcomes

  1. Atrial fibrillation burden

    Atrial fibrillation burden and/or progression to permanent atrial fibrillation as determined by device interrogation and review

    Time frame: 12 Months

  2. Heart failure hospitalizations

    Amount and severity of heart failure hospitalizations and health care utilization as reported by subjects

    Time frame: 12 months

  3. Left ventricular end systolic volume

    As determined by echocardiographic evidence

    Time frame: 12 months

  4. Time to first appropriate therapy for VT and/or VF

    Time determined by device interrogation from sensing to response

    Time frame: 12 months

  5. Percentage of RV synchronized LV pacing

    Percentage determined by device interrogation and compared to clinical outcomes

    Time frame: 12 months

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Study locations

1 site
  • Stern Cardiovascular Foundation
    Germantown, Tennessee 38138, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03305393
Lead sponsor
Stern Cardiovascular Foundation, Inc.
Responsible party
Sponsor
First posted
Oct 10, 2017
Start date
Jun 11, 2017
Primary completion
Jul 3, 2018
Completion
Jul 3, 2018
Last update
Sep 19, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
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