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CTRI Number  CTRI/2022/09/045541 [Registered on: 15/09/2022] Trial Registered Prospectively
Last Modified On: 31/08/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Other (Specify) [Treatment - change in programming mode]  
Study Design  Randomized, Crossover Trial 
Public Title of Study   A clinical trial to study the effect of two pacemaker modes - committed pacing and backup pacing, in patients undergoing pacemaker implantation for symptomatic Left Bundle Branch Block 
Scientific Title of Study   Functional and Echocardiographic outcomes of committed pacing verses backup pacing in patients undergoing conduction system pacing for symptomatic LBBB. 
Trial Acronym  EFFECtive PaCing 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anand M 
Designation  Assistant Professor 
Affiliation  Christian Medical College 
Address  Cardiology Unit IV, Department of Cardiology, Christian Medical college, Ida Scudder road, Vellore

Vellore
TAMIL NADU
632004
India 
Phone  8138032331  
Fax    
Email  dranandchn@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Anand M 
Designation  Assistant Professor 
Affiliation  Christian Medical College 
Address  Cardiology Unit IV, Department of Cardiology, Christian Medical college, Ida Scudder road, Vellore

Vellore
TAMIL NADU
632004
India 
Phone  8138032331  
Fax    
Email  dranandchn@gmail.com  
 
Details of Contact Person
Public Query  
Name  Anand M 
Designation  Assistant Professor 
Affiliation  Christian Medical College 
Address  Cardiology Unit IV, Department of Cardiology, Christian Medical college, Ida Scudder road, Vellore

Vellore
TAMIL NADU
632004
India 
Phone  8138032331  
Fax    
Email  dranandchn@gmail.com  
 
Source of Monetary or Material Support  
Christian Medical College, Vellore, Tamilnadu, India 
 
Primary Sponsor  
Name  Christian Medical College Vellore Tamilnadu India  
Address  Cardiology Unit IV, Department of Cardiology, Christian Medical college Phone number: 0416 -2283572 Mobile Number: 8138032331 Email id: dranandchn@gmail.com  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Anand M  Christian Medical College  Cardiology Unit IV, Department of Cardiology
Vellore
TAMIL NADU 		 8138032331

dranandchn@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board, Christian Medical College, Vellore, India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I447||Left bundle-branch block, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Backup pacing   Patients postpacemaker implantation will be programmed to pacing only when required for 6 months. After 6months, patient will be crossed over to other arm 
Intervention  Committed pacing   Patients postpacemaker implantation will be programmed to pacing 100% of the time for 6 months. After 6months, patient will be crossed over to other arm 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Sinus Rhythm [SR] with Symptomatic LBBB
2.EF > 50%
3.Patients undergoing successful conduction system pacing with correction of LBBB
 
 
ExclusionCriteria 
Details  1. V pacing percentage > 40% 1
2. Structural heart disease
3. Inability for functional assessment such as physical disability or orthopedic problem
4.Not giving consent for study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Echocardiographic parameters: Global longitudinal strain difference between the two groups
2.Functional assessment: Difference in METS achieved in modified bruce protocol 		 6months and 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
1.Any admission for heart failure
2.Any change in NYHA class
3.Difference in exertion time in modified Bruce protocol
4.Difference in distance covered in 6-minute walk distance test
5.Any change in NT-proBNP level
 		 6months and 12 months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   19/09/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  Data are available on reasonable request directed to the email id:dranandchn@gmail.com

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 01-04-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Background: Conduction system pacing has been shown to improve mechanical synchrony with better hemodynamic effects when compared to RV pacing.

Aim: To determine whether committed ventricular pacing leads to improvement or maintenance of LV systolic function as assessed by echocardiographic parameters and functional status in comparison to back up ventricular pacing in patients undergoing conduction system pacing for symptomatic LBBB with normal LV function.

              Methods: Randomized double blind cross over study.

Patients undergoing permanent pacemaker implantation with conduction system pacing for symptomatic LBBB with normal LV function will be randomized to either committed pacing or backup pacing for 6months. After 6months, the echocardiographic parameters and functional parameters such as 6-minute walk distance and treadmill test will be assessed. 6months interval was chosen so that pacing can have its effects on LV as per previous trials.1 After this, the two groups will be crossed over and after another 6 months, the same parameters will be reassessed.  Statistical analysis will be done using SPSS 16 software. P value of < 0.05 will be considered significant. There will be no washout period in between the cross over as the effect of the previous treatment arm would disappear within one month.  Similar protocol was used in randomized cross over studies in CRT without a washout period.2 Cross over design is planned in order to obtain adequate sample size and the patient can be his own control as executed in pervious trials.2

References

1. Chung ES, Leon AR, Tavazzi L, et al. Results of the Predictors of Response to CRT (PROSPECT) trial. Circulation. 2008 May 20;117(20):2608-16. doi: 10.1161/CIRCULATIONAHA.107.743120. Epub 2008 May 5. PMID: 18458170.

2. Rogers DP, Lambiase PD, Lowe MD, Chow AW. A randomized double-blind crossover trial of triventricular versus biventricular pacing in heart failure. Eur J Heart Fail. 2012 May;14(5):495-505. doi: 10.1093/eurjhf/hfs004. Epub 2012 Feb 6. PMID: 22312038.

 
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