ICDNCT07464834
Postcards to Improve Remote Monitoring Connectivity Among Veterans With a Disconnected Monitor
A study testing Tailored Postcard in people with ICD and Pacemaker, run by San Francisco VA Health Care System at 1 site in United States.
Trial summary
We tested the effect of mailing informational postcards to patients with cardiovascular implantable electronic devices who have lost continuous RM connectivity because of a disconnected home monitor. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ICD, Pacemaker, Implanted Loop Recorder
- What is being tested?
- Tailored Postcard
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,726 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2024to 29 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients followed by the VA National Cardiac Device Surveillance Program for CIED remote monitoring care with a wireless-capable CIED (i.e., does not require manual transmission).
- CIEDs: pacemakers, implantable cardioverter-defibrillators, and implantable loop recorders
- Patients had a remote monitoring transmission received by VA National Cardiac Device Surveillance Program within past 100 days (representing standard 90-day interval plus additional 10-day buffer in case of travel)
- Data from Abbott merlin.net, Biotronik Home Monitoring, Medtronic Carelink, or Boston Scientific Latitude indicating patient disconnected from remote monitoring for ≥16 days but ≤40 days
Who cannot join
- Address outside of United States or Puerto Rico
- Previously included in the present RCT or a complementary RCT (VANCDSP Disconnected CIED). Once a patient reconnects but then becomes disconnected again, cannot be included again
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco VA Medical Center
San Francisco, California, 94121
About this study
Official title: Postcards to Improve Remote Monitoring Connectivity Among Patients With Cardiovascular Implantable Electronic Devices and Disconnected Monitors: A Randomized, Controlled Trial
We tested the effect of mailing informational postcards to patients with cardiovascular implantable electronic devices who have lost continuous RM connectivity because of a disconnected home monitor.
Read the detailed description
Objective: To determine the effect on remote monitoring (RM) connectivity of mailing informational postcards to patients with CIEDs who have lost continuous RM connectivity because of a disconnected monitor.
Design: Parallel prospective randomized controlled trial (RCT).
Setting: Veterans Health Administration.
Participants: Randomized selection of all patients with CIEDs whose bedside or smartphone monitor had become disconnected for ≥16 but ≤40 days from the manufacturer's RM service.
Exposure: We developed postcards that notified patients about RM disconnection, described RM's clinical benefits, and provided the customer service number of their CIED manufacturer. Twice monthly, we randomized patients to either receive or not receive the postcard.
Main Outcomes and Measures: Primary outcome was median time to reconnection.
- Conditions
- ICD, Pacemaker, Implanted Loop Recorder, Remote Monitoring, Adherence, Patient
- Being tested
- Tailored Postcard
- Keywords
- Remote Monitoring Adherence, cardiovascular implantable electronic devices
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored PostcardOther
Participants received a postcard with a tailored notice that their home monitor was disconnected from remote monitoring with tips to reconnect and prompts to follow up with their CIED manufacturer or local VA clinic.
| Study group | Role | What they receive |
|---|---|---|
| Postcards | Experimental | Participants who received tailored postcard Receives: Other: Tailored Postcard |
| Controls | No intervention | Participants who did not receive a postcard (usual care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median time to monitor reconnection
Time to reconnection using median survival time and assessing differences in each group through log-rank test. Assess relative difference across two groups through Cox proportional hazards regression.
Measured: From intervention (mailing) to at least 100 days after intervention.
Secondary outcomes (1)
Binary adherence to next scheduled transmission
Assesses whether a transmission received within 10 days of scheduled transmission assessed using logistic regression.
Measured: From intervention (mailing) to at least 100 days after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start5 Aug 2024
- Primary completion29 Jul 2025
- Study completion29 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,726 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Francisco VA Health Care System
- Sponsor type
- US federal agency
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Principal investigator, Sanket Dhruva, MD, MHS, San Francisco VA Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07464834
- Sponsor's protocol ID
- VANCDSP Disconnected Monitor
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postcards to Improve Remote Monitoring Connectivity Among Patients With Cardiovascular Implantable Electronic Devices and Disconnected Monitors: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT07464834
- Acronym / sponsor ID
- VANCDSP Disconnected Monitor
- Conditions
- ICD, Pacemaker, Implanted Loop Recorder, Remote Monitoring, Adherence, Patient
- Keywords
- Remote Monitoring Adherence, cardiovascular implantable electronic devices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,726 participants (actual)
- Lead sponsor
- San Francisco VA Health Care SystemUS federal agency
- Collaborators
- US Department of Veterans Affairs
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 29 Jul 2025 (actual)
- Study completion
- 29 Jul 2025 (actual)
- First posted
- 11 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We tested the effect of mailing informational postcards to patients with cardiovascular implantable electronic devices who have lost continuous RM connectivity because of a disconnected home monitor.
Detailed description
Objective: To determine the effect on remote monitoring (RM) connectivity of mailing informational postcards to patients with CIEDs who have lost continuous RM connectivity because of a disconnected monitor.
Design: Parallel prospective randomized controlled trial (RCT).
Setting: Veterans Health Administration.
Participants: Randomized selection of all patients with CIEDs whose bedside or smartphone monitor had become disconnected for ≥16 but ≤40 days from the manufacturer's RM service.
Exposure: We developed postcards that notified patients about RM disconnection, described RM's clinical benefits, and provided the customer service number of their CIED manufacturer. Twice monthly, we randomized patients to either receive or not receive the postcard.
Main Outcomes and Measures: Primary outcome was median time to reconnection.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postcards | Experimental | Other: Tailored PostcardParticipants who received tailored postcard |
| Controls | No intervention | –Participants who did not receive a postcard (usual care) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients followed by the VA National Cardiac Device Surveillance Program for CIED remote monitoring care with a wireless-capable CIED (i.e., does not require manual transmission).
- CIEDs: pacemakers, implantable cardioverter-defibrillators, and implantable loop recorders
- Patients had a remote monitoring transmission received by VA National Cardiac Device Surveillance Program within past 100 days (representing standard 90-day interval plus additional 10-day buffer in case of travel)
- Data from Abbott merlin.net, Biotronik Home Monitoring, Medtronic Carelink, or Boston Scientific Latitude indicating patient disconnected from remote monitoring for ≥16 days but ≤40 days
Key exclusion criteria (2 listed)
- Address outside of United States or Puerto Rico
- Previously included in the present RCT or a complementary RCT (VANCDSP Disconnected CIED). Once a patient reconnects but then becomes disconnected again, cannot be included again
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored PostcardParticipants received a postcard with a tailored notice that their home monitor was disconnected from remote monitoring with tips to reconnect and prompts to follow up with their CIED manufacturer or local VA clinic. | Other | Postcards |
Primary outcome
Median time to monitor reconnection
Time frame: From intervention (mailing) to at least 100 days after intervention.
Time to reconnection using median survival time and assessing differences in each group through log-rank test. Assess relative difference across two groups through Cox proportional hazards regression.
1 secondary outcome
Binary adherence to next scheduled transmission
Time frame: From intervention (mailing) to at least 100 days after intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored Postcard in people with ICD and Pacemaker, run by San Francisco VA Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median time to monitor reconnection (time frame: From intervention (mailing) to at least 100 days after intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.