Post marketing registry to study the effect of the closed loop stimulation in patients who are suffering from Sinus node disease

Clinical benefits of the Closed Loop Stimulation in Sinus Node Disease

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2017/02/007890

Enrollment

1308

Registered

2017-02-16

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Patients indicated for IPG or ICD who need dual chamber pacing due to SND, with or without AV block

Interventions

Intervention1: Evia DR/-T (Pro MRI and non Pro MRI) Etrinsa 8 DR/-T( Pro MRI and non Pro MRI): CLS mode on Control Intervention1: Nil: Nil Control Intervention2: Evia DR/-T (Pro MRI and non Pro MRI) E

Eligibility

Inclusion criteria

Inclusion criteria: • Patients with Class I or II recommendations for permanent pacing due to SND, with or without AV block according to the current guidelines • Patients for whom dual-chamber pacing is indicated or preferred • Patients with an optimized and stable antiarrhythmic medical therapy at the time of enrollment

Exclusion criteria

Exclusion criteria: • Permanent AF • NYHA Class IV Heart Failure • Stage V kidney dysfunction • Any indication to Cardiac Resynchronization Therapy (CRT) • Life expectancy • Atrial fibrillation ablation (left pulmonary veins) or other cardiac surgery • Minors • Pregnant or breast-feeding patients • Participation in another interventional trial

Design outcomes

Primary

Measure	Time frame
he Primary Endpoint is the time to the first post randomization event of SPAF/PersAF or Stroke/TIA, whichever comes first.Timepoint: Day of randomization till the end of study	—

Secondary

Measure	Time frame
Assess the time to the first post randomization event of: â?¢ SPAF (6 mins) â?¢ PersAF â?¢ PermAF â?¢ Stroke/TIA â?¢ wHF Hospitalization â?¢ Death from any causes Furthermore to assess all events of: â?¢ NSPAF before randomization and during the FU period â?¢ SPAF, PersAF and Stroke/TIA events post randomizationTimepoint: Assess the time to the first post randomization event of: â?¢ SPAF (6 mins) â?¢ PersAF â?¢ PermAF â?¢ Stroke/TIA â?¢ wHF Hospitalization â?¢ Death from any causes Furthermore to assess all events of: â?¢ NSPAF before randomization and during the FU period â?¢ SPAF, PersAF and Stroke/TIA events post randomization	—

Measure

Time frame

Assess the time to the first post randomization event of: â?¢ SPAF (6 mins) â?¢ PersAF â?¢ PermAF â?¢ Stroke/TIA â?¢ wHF Hospitalization â?¢ Death from any causes Furthermore to assess all events of: â?¢ NSPAF before randomization and during the FU period â?¢ SPAF, PersAF and Stroke/TIA events post randomizationTimepoint: Assess the time to the first post randomization event of: â?¢ SPAF (6 mins) â?¢ PersAF â?¢ PermAF â?¢ Stroke/TIA â?¢ wHF Hospitalization â?¢ Death from any causes Furthermore to assess all events of: â?¢ NSPAF before randomization and during the FU period â?¢ SPAF, PersAF and Stroke/TIA events post randomization

—

Countries

China, Democratic People's Republic of Korea, India, Italy, Malaysia, Singapore, Spain, Taiwan

Contacts

Public ContactGarima Bahl

Biotronik Medical Devices India

garima.bahl@biotronik.com011-40587850

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026