Safety and Efficacy Study of IPG Patient With Home Monitoring

NCT01523704 | Completed Results

• 1 other identifier: atHome Study
• Study Type: interventional
• Target: 1,327
• Locations: 1 country
• Sites: 1

Brief Summary

The number of patients with implantable pulse generator (IPG) has steadily increased in Japan causing increment in number of in office follow-ups and greater burden on many hospitals. The purpose of this multicenter randomized study is to demonstrate that BIOTRONIK Home Monitoring system reduces office follow-up visits without compromising patient safety.

Conditions

Bradyarrhythmia

Outcome Measures

Primary Outcomes (1)

• Evaluation for Equivalence of the Number of Patients Who Meet the Composite Safety Endpoint Between Home Monitoring Group(HM) and Control Group Which is HM + Conventional In-office Follow-up

  The purpose of the primary endpoint is to compare the composite safety endpoint, Safety Event Rate (SER) which includes death, incidence of strokes and cardiovascular related serious adverse events requiring surgical interventions (e.g. device explants or lead revision) between HM Group and Control Group. Safety will be evaluated in the following testable hypothesis in an equivalence (non-inferiority) format: HØ: The safety event rate (SER) for a 24-month duration for Group 1 is not equivalent to the SER for Group 2. SER Group 1 - SER Group 2 ≥ Ha : The safety event rate (SER) for a 12-month duration for Group 1 is equivalent to the SER for Group 2 SER Group 1 - SER Group 2 \< Where, ( )represents the allowable clinically significant difference. 5% was set for the study. A rejection of the null hypothesis (HØ) will indicate that the safety event rate for Group 1 is equivalent (non-inferior) to that of Group 2.

  2 years

Secondary Outcomes (2)

• The Median (IQR) Numbers of In-office Follow-up（FU) Visits Per Patient-year

  2 years

• Efficacy of Home Monitoring：Average Cost for In-office Follow-up Per Patient-year

  2 years

Study Arms (2)

Home Monitoring(HM)

EXPERIMENTAL

Patients assigned to HM Group(HM follow-up ONLY) will have Home Monitoring programmed ON. They will be seen in the office for device interrogations at the 3-month follow-up, and at 27 month follow-up. In the meanwhile the device status will be evaluated using HM only for the 9, 15 and 21 month scheduled follow-up. Patients will visit the hospital for device interrogation on 27 month final follow-up.

Device: BIOTRONIK Home Monitoring System

Control

ACTIVE COMPARATOR

Patients assigned to Control Group (HM + Conventional In-office follow-up - Control group) will have HM programmed ON. In addition to HM, these patients will visit the hospital for device interrogation at 3, 9, 15, 21 and 27 month follow-ups.

Device: BIOTRONIK Home Monitoring System with In-office Follow-up

Interventions

BIOTRONIK Home Monitoring System DEVICE

Home Monitoring system transfers implantable device's data to the main server via internet.

Home Monitoring(HM)

BIOTRONIK Home Monitoring System with In-office Follow-up DEVICE

Control

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Indicated for IPG implantation under Japanese guidelines
• Implanted within the last 45 days or being considered for implant with a BIOTRONIK IPG with Home Monitoring
• Able to utilize HM system throughout the study
• Ability to give informed consent
• Geographically stable and able to return for follow-ups for 27 months
• Over 20 years old
• Patient able to understand and follow the procedure stated in protocol

You may not qualify if:

• Contraindicated for IPG under Japanese guidelines
• Patients who are currently included in another cardiac clinical study
• Patients with expected life period of less than two years
• Patients who might undergo heart transplantation in next two years.

Sponsors & Collaborators

• Biotronik Japan, Inc.: lead

Study Sites (1)

Fujita Health University

Toyoake, Aichi-ken, 4701192, Japan

Location

Related Publications (1)

• Watanabe E, Yamazaki F, Goto T, Asai T, Yamamoto T, Hirooka K, Sato T, Kasai A, Ueda M, Yamakawa T, Ueda Y, Yamamoto K, Tokunaga T, Sugai Y, Tanaka K, Hiramatsu S, Arakawa T, Schrader J, Varma N, Ando K. Remote Management of Pacemaker Patients With Biennial In-Clinic Evaluation: Continuous Home Monitoring in the Japanese At-Home Study: A Randomized Clinical Trial. Circ Arrhythm Electrophysiol. 2020 May;13(5):e007734. doi: 10.1161/CIRCEP.119.007734. Epub 2020 Apr 28.

  PMID: 32342703 DERIVED

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

We used one RM platform exclusively. This maintained continuous RM with 90.1% daily transmission success over two years, matching rates observed in other (shorter) trials. Whether our results are transferable to other RM platforms is uncertain.

Results Point of Contact

• Title: Eiichi Watanabe, MD, PhD
• Organization: Fujita Health University School of Medicine

enwatan@fujita-hu.ac.jp

+81-562-93-2312

Study Officials

• Eiichi Watanabe, MD

  Fujita Health University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2012
• First Posted: February 1, 2012
• Study Start: January 1, 2012
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: January 27, 2021
• Results First Posted: January 27, 2021

Record last verified: 2021-01

Locations

JP (1)