Optimized Biventricular Pacing Allograft Recipients

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Brief Title

Optimized Biventricular Pacing Allograft Recipients

Official Title

Optimized Biventricular Pacing in Allograft Recipients

Brief Summary

      This study tests optimization of biventricular pacing (BiVP) in patients with dilated
      cardiomyopathy (DCM) or ischemic cardiomyopathy (ICM) during cardiac transplantation in
      patients with advanced cardiac failure. It examines the effects of atrioventricular delay
      (AVD), interventricular delay (VVD or RLD), and left ventricular pacing site (LVPS) on
      cardiac output (CO). BiVP results are compared to traditional atrial (AAI) pacing at an
      identical heart rate.
    

Detailed Description

      This study is designed to increase the benefit of biventricular pacing (BiVP), which is an
      established therapy for advanced heart failure. The investigators will test 6 left
      ventricular (LV) pacing sites and 16 timing sequences in the operating room just before
      cardiac transplant. Pacing will be implemented after patients have been anticoagulated and
      connected to the heart-lung machine. Pacing by previously implanted pacemakers will be
      suppressed. The investigators will measure cardiac output (CO) by aortic flow probe (AFP),
      left ventricular (LV) contractility by a combination of trans-septal pressure gradients, and
      simultaneous left ventricular pressure (LVP)and transesophageal echocardiography (TEE) during
      transient reduction of inflow of blood to the heart by vena caval occlusion. The goal is to
      prove that this optimization will increase the amount of blood pumped by the failing heart by
      15% as compared with standard atrial (AAI) pacing. The testing protocol is 12.5 minutes in
      duration, and the entire protocol should be executable in 20 minutes. Care will not be
      altered otherwise. Results will improve management of the general population of patients with
      advanced heart failure while minimally increasing the risk to patients undergoing cardiac
      transplantation. Benefits of this study should include: improved patient selection for BiVP
      and a decrease in the presently recognized 30-40% incidence of BiVP nonresponders.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Cardiac Output

Secondary Outcome

 Atrial Latency

Condition

Dilated Cardiomyopathy

Intervention

BiVP

Study Arms / Comparison Groups

 BiVP Pacing
Description:  BIVP optimize AVD, VVD, and LVPS parameters and assess the effect on cardiac output.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

12

Start Date

January 2007

Completion Date

March 2011

Primary Completion Date

March 2011

Eligibility Criteria

        Inclusion Criteria:

          -  New York Heart Association (NYHA) heart failure class III/IV

          -  Left Ventricular Ejection Fraction (LVEF) <36%

          -  QRS >120 msec

        Exclusion Criteria:

          -  Intracardiac shunts

          -  Sinus tachycardia >120 bpm

          -  Second or third degree heart block

          -  Previous cardiac surgery

          -  Mechanical circulatory assistance

          -  Atrial fibrillation
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Henry M Spotnitz, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01290822

Organization ID

AAAC1492

Secondary IDs

1R01HL080152-01A2

Responsible Party

Sponsor-Investigator

Study Sponsor

Henry M. Spotnitz

Collaborators

 National Heart, Lung, and Blood Institute (NHLBI)

Study Sponsor

Henry M Spotnitz, MD, Principal Investigator, Columbia University


Verification Date

August 2016