| CTRI Number |
CTRI/2025/07/091118 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A Study to Evaluate the Effect of Bachmann Bundle Pacing on Heart Function in Patients with Non-Obstructive Hypertrophic Cardiomyopathy and Preserved Heart Pumping Ability |
|
Scientific Title of Study
|
Bachmann Bundle Area Pacing for Atrial Resynchronization Therapy in Patients With HFpEF: A Randomized Trail (BART-HFpEF) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Calambur Narasimham |
| Designation |
Senior Consultant Cardiologist & Director of Electrophysiology |
| Affiliation |
Asian Institute Of Gastroenterology |
| Address |
Department of Cardiology 1st Floor Cluster C Room no 3 1-66/AIG/2to5 Mindspace Road Gachibowli Hy1derabad Telangana
Hyderabad
TELANGANA
500032
India |
| Phone |
4042444222 |
| Fax |
|
| Email |
calambur1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Muthiah Subramanian |
| Designation |
Consultant Cardiologist |
| Affiliation |
Asian Institute Of Gastroenterology |
| Address |
Department of Cardiology 1st floor Near device clinic area Room No 5 1-66/AIG/2to5 Mindspace Road Gachibowli Hy1derabad Telangana
Hyderabad
TELANGANA
500032
India |
| Phone |
9843144444 |
| Fax |
|
| Email |
muthiah727@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Daljeet saggu |
| Designation |
Consultant Cardiologist Electrophysiologist |
| Affiliation |
Asian Institute Of Gastroenterology |
| Address |
Department of Cardiology 1st Floor near Device clinic Area Room no 5 1-66/AIG/2to5 Mindspace Road Gachibowli Hy1derabad Telangana
Hyderabad
TELANGANA
500032
India |
| Phone |
8978428938 |
| Fax |
|
| Email |
drdaljeetsaggu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Asian Institute Of Gastroenterology |
| Biotronic SE & Co KG (Biotronic) |
|
|
Primary Sponsor
|
| Name |
Biotronic SE & Co KG (Biotronic) |
| Address |
Woermannkehre 1 12359 Berlin Germany |
| Type of Sponsor |
Other [Multi-National Cardiovascular Biomedical Research and Technology Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr C Narasimahan |
Asian Institute Of Gastroenterology |
Department of Cardiology 1st floor Cluster C Room no 3 1-66/AIG/2to5 Mindspace Road Gachibowli Hy1derabad Telangana
Hyderabad
TELANGANA |
4042444222
calambur@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Asian Institute Of Gastroenterology(IEC-AIG) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I508||Other heart failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Device Implantation |
All participants will receive a dual chamber pacemaker. Patients will be randomized to either Bachmann Bundle Area or the Right Atrial Appendage atrial lead implantation. Pacing will be set at DDDR mode 70 beats per minute for 6 weeks followed by a 6-week washout. During the washout period the device will be programmed to VVI at 30 beats per minute. After six weeks of washout, device will be programmed to DDDR at 70 per minute. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
-Symptomatic patients more than 18 years with Stage C HFpEF (LVEF greater than 50%) and chronotropic incompetence on optimized guideline indicated HF medical therapy
-NYHA more than Class 2 and an elevated N-terminal pro-B type natriuretic peptide (NT-proBNP) level higher than 300 pg/ml
-Partial or complete inter-atrial block (IAB) on ECG.
-IAB will be defined as a maximum P wave duration greater than 120ms. Partial IAB will be defined as a P wave greater than 120ms with notching in leads II, III, or aVF. A P wave duration greater than 120ms and a biphasic morphology in leads II, III, aVF will be classified as advanced or complete IAB.
-Baseline PR interval less than 200ms
-Baseline HR less than 60/min or an average heart rate on baseline holter that is less than 65/min
|
|
| ExclusionCriteria |
| Details |
-Persistent atrial fibrillation
-History of corrected or uncorrected congenital heart disease
-Severe mitral valve disease
-Previous mitral surgery
- Indication for Ventricular pacing
-Pregnancy
-Stage IV/V Chronic Kidney Disease
-Multiple comorbidities with an estimated life expectancy more than 1 year
-Patients unable to give written or informed consent
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relative Change in N-proBNP compared with baseline |
4 weeks 8 weeks 12 weeks and 24 weeks (derived from the study duration of 24 months with key intervals likely aligned with the washout period and follow-up phases) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Diastolic function assessment by echocardiography
2) HF Hospitalizations
3) Kansas City Cardiomyopathy Questionnaire
4) NYHA functional class,
5) 6WMD
6) atrial arrhythmia burden
7) daily diuretic requirement. |
4 weeks 8 weeks 12 weeks & 24 weeks (derived from the study duration of 24 months with key intervals likely aligned with the washout period & follow-up phases). |
|
|
Target Sample Size
|
Total Sample Size="124"
Sample Size from India="124"
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)
|
01/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/09/2025 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [calambur1@gmail.com].
- For how long will this data be available start date provided 25-07-2025 and end date provided 25-07-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Bachmann Bundle Area Pacing for Atrial Resynchronization Therapy in Patients with HFpEF A Randomized Trial BART HFpEF. To assess the effect of atrial resynchronization using Bachmann Bundle Area Pacing in symptomatic patients with Heart Failure with Preserved Ejection Fraction HFpEF and interatrial block IAB. This multi-center prospective randomized controlled trial will include symptomatic patients over 18 years with stage C HFpEF. Key inclusion criteria include NT proBNP level greater than 300 pg per ml and NYHA Class 2 or higher. All participants will receive a dual chamber pacemaker. Patients will be randomized to either Bachmann Bundle Area or the Right Atrial Appendage atrial lead implantation. Pacing will be set at DDDR mode 70 beats per minute for 6 weeks followed by a 6-week washout. During the washout period the device will be programmed to VVI at 30 beats per minute. After six weeks of washout, device will be programmed to DDDR at 70 per minute. Primary endpoint is Change in NT proBNP levels from baseline. Secondary Endpoints include relative change in diastolic function on echocardiography, six minute walk distance, NYHA class, Heart failure hospitalizations, Atrial arrhythmia burden, Daily diuretic requirement, Kansas City Cardiomyopathy Questionnaire score. The sample size required to detect a 50 pg per ml change in NT proBNP with 90 percent power and 5 percent significance will be a 124 patients. Enrollment will be more 18 months, with a minimum follow up of 6 months. |