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

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2017/02/007890
• Date of registration: 16-02-2017
• Prospective Registration: Yes
• Primary sponsor: BIOTRONIK SE and Co KG
• Public title: Post marketing registry to study the effect of the closed loop stimulation in patients who are suffering from Sinus node disease
• Scientific title: Clinical benefits of the Closed Loop Stimulation in Sinus Node Disease
• Date of first enrolment: 25-02-2017
• Target sample size: 1308
• Recruitment status: Not Yet Recruiting
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=15669
• Study type: PMS
• Study design: Randomized, Parallel Group Trial; Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Participant Blinded
• Phase: Post Marketing Surveillance

Countries of recruitment

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

Contacts

• Name: Garima Bahl
• Affiliation: Biotronik Medical Devices India

• Name: Garima Bahl
• Affiliation: Biotronik Medical Devices India

Key inclusion & exclusion 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: • Permanent AF

• NYHA Class IV Heart Failure

• Stage V kidney dysfunction

• Any indication to Cardiac Resynchronization Therapy (CRT)

• Life expectancy < 1 years

• Atrial fibrillation ablation (left pulmonary veins) or other cardiac surgery < 3 m

• Minors

• Pregnant or breast-feeding patients

• Participation in another interventional trial

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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)
Etrinsa 8 DR/-T( Pro MRI and non Pro MRI): DDDR Mode

Primary Outcome(s)

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 Outcome(s)

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

Secondary ID(s)

NIL

Source(s) of Monetary Support

Biotronik SE and Co. KG Address: Center for Clinical research Woermannkehre 1, D-12359 Berlin

Ethics review

Status: Approved
Approval date: 05/10/2016
Contact:

Institutional Ethics Committee, Max Super Specilaity Hospital