Health Condition 1: I499- Cardiac arrhythmia, unspecified
Conditions
Interventions
Intervention1: Diagnostic Electrophysiology Catheter: The Reprocessed Response Diagnostic Electrophysiology Catheters are manufactured in various fixed curves and electrode spacing for electrophysiolo
Sponsors
Newtech Medical Devices Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: Pre-operative, Operative, Day2, Day7 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.Timepoint: Pre-operative, Operative, Day2, Day7 | — |
Countries
India
Contacts
Public ContactMr Praveen Shukla
Newtech Medical Devices Pvt Ltd
Outcome results
None listed