Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02441101
Other study ID # 201409760
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date February 1, 2016
Est. completion date February 11, 2020

Study information

Verified date May 2024
Source University of Iowa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This clinical study has been designed to test whether a new pacing therapy would lead to improvement in heart function, symptoms and quality of life in a specific group of heart failure patients. This group has a unique electrical conduction problem (Right Bundle Branch Block) that did not respond well to the current available pacing therapy.


Description:

This pilot clinical trial will be a randomized single blinded cross over trial. Each subject will undergo three study stages. Subject will be randomized initially to either of the two arms; experimental or placebo, and then will be followed up for 3 months for the first stage to assess outcomes. In the second stage, both arms transition to a two months, intervention free, wash out period. Finally, at the third stage both arms will cross over and subject will be followed up for an additional 3 months for outcomes assessment.


Recruitment information / eligibility

Status Terminated
Enrollment 6
Est. completion date February 11, 2020
Est. primary completion date February 11, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Cardiomyopathy; ischemic or non-ischemic on optimal medical therapy per current heart failure treatment guidelines for at least 3 months. - LVEF < 35% by trans-thoracic echocardiogram assessment - Prior implantation of pacemaker/defibrillator with at least an atrial and RV mid septal lead. Atrial lead can be waived if RV lead has atrial sensing capabilities* - Normal sinus rhythm at enrollment - RBBB with QRS duration >120 msec on 12 lead surface EKG. - PR interval <250 msec on 12 lead surface EKG - Subjects with biventricular pacemaker/ICD will be eligible for enrollment if their LV lead pacing function has been turned off by the subject's primary cardiologist prior to study enrollment for at least 3 months (this could be due to lead malfunction or the decision to deactivate the LV pacing therapy for any reason per primary cardiologist discretion) Exclusion Criteria: - Age younger than 18 years old - Pregnancy - Acute Myocardial infarction within 6 months of entry into the study - Inotrope dependent heart failure condition - Left ventricular assist device or heart transplantation - Any other known conditions other than heart failure that could limit survival to < 6 months. - Atrial fibrillation or flutter burden >10% of the time within the last 6 months - Atrioventricular node disease that requires ventricular pacemaker support >10% of the time

Study Design


Intervention

Device:
RV DDD(R)-60 with AV optimization
Device to be programmed for RV pacing with AV interval optimization at the bedside to produce QRS fusion with the native conduction down the native left bundle on surface EKG
RV DDD(R)-60
AV settings programmed to minimize RV pacing - standard demand pacing programming.

Locations

Country Name City State
United States University of Iowa Hospitals and Clinics Iowa City Iowa

Sponsors (1)

Lead Sponsor Collaborator
Barry London

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of LV Ejection Fraction Compared to Baseline LV Ejection Fraction is defined as [(end diastolic volume minus end systolic volume) / (end diastolic volume] as measured by echocardiography.
Comparison of LV Ejection Fraction with RV pacing optimization on vs. RV pacing optimization off.
Arm 1 is RV pacing optimization on then off Arm 2 is RV pacing optimization off then on
Baseline to 3 months
Secondary Electrocardiographic: QRS Duration Comparing baseline to intervention on Comparing intervention off to intervention off Expect statistically significant decrease with intervention on Baseline to 3 months
See also
  Status Clinical Trial Phase
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT05196659 - Collaborative Quality Improvement (C-QIP) Study N/A
Active, not recruiting NCT05896904 - Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction N/A
Completed NCT05077293 - Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
Recruiting NCT05631275 - The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
Enrolling by invitation NCT05564572 - Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology N/A
Enrolling by invitation NCT05009706 - Self-care in Older Frail Persons With Heart Failure Intervention N/A
Recruiting NCT04177199 - What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
Terminated NCT03615469 - Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY) N/A
Recruiting NCT06340048 - Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure Phase 1/Phase 2
Recruiting NCT05679713 - Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
Completed NCT04254328 - The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure N/A
Completed NCT03549169 - Decision Making for the Management the Symptoms in Adults of Heart Failure N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Enrolling by invitation NCT05538611 - Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
Recruiting NCT04262830 - Cancer Therapy Effects on the Heart
Completed NCT06026683 - Conduction System Stimulation to Avoid Left Ventricle Dysfunction N/A
Withdrawn NCT03091998 - Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support Phase 1
Recruiting NCT05564689 - Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy