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Application of Right Atrial Left Ventricular Fusion Pacing in Patients With CRT Indications

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03071978
Recruitment Status : Completed
First Posted : March 7, 2017
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Brief Summary:
This study is designed to assess the clinical outcomes of Left-Ventricular (LV) fusion pacing compared to Bi-Ventricular (BV) pacing, also known as Cardiac Resynchronization Therapy (CRT), in Chinese Heart Failure (HF) population. Specifically, the study will assess the changes of cardiac function of each group through 3-month follow up/ 6-month follow up compared with original outcomes before aCRT (adaptive Cardiac Resynchronization Therapy) implantation. Secondly, the study will assess whether parameters of aCRT that were tested in Western population are relevant to parameters of Chinese HF patients.

Condition or disease Intervention/treatment Phase
Heart Failure Device: CRT with LV-only pacing / bi-ventricular pacing Not Applicable

Detailed Description:

Traditional dual-chamber pacemakers usually utilize pacing at right atrium (RA) and right ventricle (RV). But many clinical studies have proved that permanent RV pacing could cause ventricular desynchronization in electrical activation and mechanical movement, also may lead to atrial fibrillation and cardiac failure in the long term. Cardiac Resynchronization Therapy (CRT) can overcome the ventricular desynchrony caused by permanent RV pacing, through pacing both left and right ventricles. But the cost of CRT device is usually expensive in emerging markets like in China. Recently, a few clinical studies have demonstrated that LV-fusion pacing (without RV pacing) using adaptive CRT feature provides better clinical outcomes than RV pacing, and also equivalent clinical improvements compared to conventional CRT pacing. However, it is unknown whether similar results can be duplicated in Chinese population as the clinical profile of Chinese CRT populations is different from that of Western CRT population.

This study is designed to assess the clinical outcomes of Left-Ventricular (LV) fusion pacing compared to Bi-Ventricular (BV) pacing in Chinese Heart Failure population. Specifically, the study will assess the changes of cardiac function of each group through 3-month follow up/ 6-month follow up compared with original outcomes before aCRT implantation. Secondly, the study will assess whether parameters of aCRT that were tested in Western population are relevant to parameters of Chinese HF patients.

CRT-indicated heart failure patients who meet the Inclusion & Exclusion criteria will be enrolled voluntarily in this study. No intervention will be assigned to enrolled patients. CRT therapy will be assigned according to the Guideline (ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012). Left-Ventricular (LV) fusion pacing or Bi-Ventricular (BV) pacing mode, both included in CRT therapy, will be applied upon physicians' judgment based on the Guideline and patients' specific situations. Both pacing modes, as well as all the clinical assessments in this study, are routine cares in clinical practice.

The study will enroll up to 30 subjects in each group (LV pacing group and BV pacing group) that meet the indication for CRT therapy, and also the Inclusion & Exclusion criteria. Consented subjects will receive CRT therapy and two follow-ups in the following 3 and 6 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Application of Right Atrial Left Ventricular Fusion Pacing in Patients With CRT (Cardiac Resynchronization Therapy) Indications
Actual Study Start Date : April 13, 2017
Actual Primary Completion Date : January 8, 2019
Actual Study Completion Date : January 29, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: LV-fusion pacing
Left Ventricular pacing (without Right Ventricular pacing)
Device: CRT with LV-only pacing / bi-ventricular pacing
LV-fusion pacing group received cardiac resynchronization therapy with adaptive algorithm and disabled RV pacing. While BV pacing group received conventional cardiac resynchronization therapy without adaptive algorithm.

Active Comparator: BV pacing
Bi-Ventricular pacing
Device: CRT with LV-only pacing / bi-ventricular pacing
LV-fusion pacing group received cardiac resynchronization therapy with adaptive algorithm and disabled RV pacing. While BV pacing group received conventional cardiac resynchronization therapy without adaptive algorithm.




Primary Outcome Measures :
  1. Left Ventricular Ejection Fraction (LVEF) [ Time Frame: 6-month follow up after CRT implantation ]
    Change of Left Ventricular Ejection Fraction (LVEF) from Baseline to 6-month follow-up


Secondary Outcome Measures :
  1. New York Heart Association (NYHA) class [ Time Frame: 6-month follow up after CRT implantation ]
    Change of New York Heart Association (NYHA) class from Baseline to 6-month follow-up

  2. 6-minute walking distance (6MWD) [ Time Frame: 6-month follow up after CRT implantation ]
    Change of 6-minute walking distance (6MWD) from Baseline to 6-month follow-up

  3. ECG QRS duration [ Time Frame: 6-month follow up after CRT implantation ]
    Change of ECG QRS duration from Baseline to 6-month follow-up

  4. echocardiographic assessments (including LVESV, LVEDV, LVESD, LVEDD) [ Time Frame: 6-month follow up after CRT implantation ]
    Change of echocardiographic assessments (including LVESV, LVEDV, LVESD, LVEDD) from Baseline to 6-month follow-up



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18~80
  • Life expectancy > 1 year
  • Sign Informed Consent
  • CRT-indicated
  • NYHA (New York Heart Association) class II and III
  • PR (term in Electrocardiograph) interval < 200 ms
  • ECG (Electrocardiograph) LBBB (left bundle branch block)

Exclusion Criteria:

  • Patient with severe liver or kidney dysfunction
  • CRT-contraindication
  • CRT-upgraded
  • Persistent AF (atrial fibrillation)
  • AV block (atrioventricular block)
  • RBBB (right bundle branch block)
  • Valvular Disease
  • LV threshold ≥ 3.5 volt
  • Patient is unwilling to sign the informed consent
  • Patient is pregnant or has pregnancy intention in the study duration
  • Patient has a medical condition that would limit study participation
  • Patient is enrolled in a concurrent study that may affect the outcome of this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03071978


Locations
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China, Beijing
Fuwai Hospital
Beijing, Beijing, China, 010
China, Jiangsu
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 025
China, Shanghai
Zhongshan Hospital
Shanghai, Shanghai, China, 021
China, Xinjiang
First Affiliated Hospital of Xinjiang Medical University
Urumqi, Xinjiang, China, 0991
China, Zhejiang
Greentown Hospital
Hangzhou, Zhejiang, China, 0571
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
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Principal Investigator: Yan-gang Su, M.D. ZhongShan Hospital, Shanghai
Principal Investigator: Shu Zhang, M.D. Fuwai Hospital, Beijing
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Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT03071978    
Other Study ID Numbers: LV Study
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
Heart Failure
LV-fusion pacing
Cardiac Resynchronization Therapy
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases