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CTRI Number  CTRI/2025/08/093631 [Registered on: 25/08/2025] Trial Registered Prospectively
Last Modified On: 04/12/2025
Post Graduate Thesis   
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   Study of the Newtech Catheter for Detecting Irregular Heartbeats. 
Scientific Title of Study   A Prospective, Interventional, Single-Center, Single-Arm Clinical Investigation to Evaluate the Safety and Performance of the Newtech Diagnostic Electrophysiology Catheter for Intracardiac Mapping in Patients Undergoing Electrophysiology Studies for Cardiac Arrhythmias. 
Trial Acronym  NIL 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
NMDPT/DEC-03/CI-P/081 Ver 1.1 dated 16 Oct 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vikas Gupta 
Designation  Cardiologist Surgeon  
Affiliation  Heart and General Hospital Jaipur 
Address  Heart and General Hospital H7 Vivekanand Marg Panch Batti C Scheme Ashok Nagar Jaipur Rajasthan 302001

Jaipur
RAJASTHAN
302001
India 
Phone  9540364009  
Fax    
Email  vikasgupta9317@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Praveen Shukla  
Designation  Regulatory Head 
Affiliation  Newtech Medical Devices Pvt Ltd 
Address  Newtech Medical Devices Pvt Ltd. 14/5 NH-19 Pocket B Sector 27 Faridabad Haryana 121003

Faridabad
HARYANA
121003
India 
Phone  9717990905  
Fax    
Email  praveenshukla@ntmdevices.in  
 
Details of Contact Person
Public Query  
Name  Mr Praveen Shukla  
Designation  Regulatory Head 
Affiliation  Newtech Medical Devices Pvt Ltd 
Address  Newtech Medical Devices Pvt Ltd. 14/5 NH-19 Pocket B Sector 27 Faridabad Haryana 121003

Faridabad
HARYANA
121003
India 
Phone  9717990905  
Fax    
Email  praveenshukla@ntmdevices.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Newtech Medical Devices Pvt. Ltd. 
Address  14/5, NH-19, Pocket B, Sector 27, Faridabad, Haryana 121003 
Type of Sponsor  Other [(Medical device Manufacturer)] 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vikas Gupta  Heart and General Hospital, Jaipur  Cardiology department, Cardiology Division, First floor,7 Vivekanand Marg Panch Batti C Scheme Ashok Nagar Jaipur Rajasthan 302001
Jaipur
RAJASTHAN 		 9540364009

heartghospital@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Heart and General Hospital ethics commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I499||Cardiac arrhythmia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Diagnostic Electrophysiology Catheter  The Reprocessed Response Diagnostic Electrophysiology Catheters are manufactured in various fixed curves and electrode spacing for electrophysiological mapping for the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites. 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1.Adults aged 18 years or older.
2.Patients with suspected or confirmed cardiac arrhythmias who are scheduled for an electrophysiology EP procedure requiring diagnostic intracardiac mapping.
3.Patients in stable clinical condition, suitable for elective EP studies
4.Ability to provide written informed consent prior to any study-related procedures.
5.Subject (or legally authorized representative) has provided written informed consent prior to enrollment.
6.Willing and able to comply with the protocol-required follow-up schedule.
 
 
ExclusionCriteria 
Details  1.Presence of acute conditions that may render the EP study findings unrepresentative of the patient’s typical cardiac rhythm, including:
- Significant electrolyte imbalance
- Acute ischemia
- Drug toxicity
2.Hemodynamic instability or ongoing myocardial infarction at the time of enrollment.
3.Patients with unstable angina or at high risk of life-threatening arrhythmias, where induced arrhythmias may be extremely difficult to terminate. (As per IFU contraindications)
4.Known hypersensitivity or allergy to materials used in the catheter (e.g., polyurethane, stainless steel, or electrode materials).
5.Pregnant or lactating women.
6.Patients with active systemic infection or local infection at the vascular access site.
7.Patients in another interventional clinical trial within the last 30 days.
8.Any condition that, in the opinion of the investigator, would make participation in the study medically inappropriate, pose a risk to the patient, or interfere with the study objectives
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome
Modification(s)  
Outcome  TimePoints 
• To confirm the clinical safety and performance of the Newtech Diagnostic Electrophysiology Catheter, demonstrated by the successful completion of the intended electrophysiological mapping procedure and the absence of any device-related serious adverse events during or immediately after the procedure.  Pre-operative, Operative, Day2, Day7 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Physician feedback on catheter handling (insertion, torque, navigation, withdrawal).

Smooth advancement & positioning under fluoroscopy without issues.

Quality & stability of intracardiac signals & stimulation effectiveness.

Procedure-related complications (e.g., embolism, bleeding, perforation, etc.).

Overall success rate of the diagnostic procedure without catheter issues.

Adverse events during/after the procedure, with details on severity & cause. 		 Pre-operative, Operative, Day2, Day7 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/09/2025 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This is a prospective, interventional, single-center, single-arm, open-label clinical investigation designed to evaluate the clinical safety and performance of the Newtech Diagnostic Electrophysiology Catheter in patients undergoing electrophysiological (EP) procedures for the evaluation of cardiac arrhythmias.

Eligible patients with a clinical indication for Electrophysiology mapping will be enrolled following written informed consent. The investigational device will be used for intracardiac signal acquisition and electrical stimulation from endocardial and intravascular sites, in accordance with its approved Instructions for Use (IFU) and standard electrophysiological practice. The catheter will be inserted via a central venous approach, commonly through the femoral vein, and manipulated under fluoroscopic guidance by trained electrophysiologists.

 
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