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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03305393
• Other study ID #: IMPROVE RESPONSE
• Status: Terminated
• Phase: N/A
• Start date: June 11, 2017
• Est. completion date: July 3, 2018

Study information

• Verified date: September 2019
• Source: Stern Cardiovascular Foundation, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: July 3, 2018
• Est. primary completion date: July 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• 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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
United States	Stern Cardiovascular Foundation	Germantown	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Stern Cardiovascular Foundation, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 Months
Primary	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	12 months
Secondary	Atrial fibrillation burden	Atrial fibrillation burden and/or progression to permanent atrial fibrillation as determined by device interrogation and review	12 Months
Secondary	Heart failure hospitalizations	Amount and severity of heart failure hospitalizations and health care utilization as reported by subjects	12 months
Secondary	Left ventricular end systolic volume	As determined by echocardiographic evidence	12 months
Secondary	Time to first appropriate therapy for VT and/or VF	Time determined by device interrogation from sensing to response	12 months
Secondary	Percentage of RV synchronized LV pacing	Percentage determined by device interrogation and compared to clinical outcomes	12 months