NCT03302494: WAVECREST2

WAveCrest Vs. Watchman TranssEptal LAA Closure to REduce AF-Mediated STroke 2

Terminated Phase 3 Results posted Last updated 12 March 2025

What this trial tests

Phase 3 trial testing Coherex WaveCrest® Left Atrial Appendage Occlusion System in Stroke in 248 participants. Terminated before completion.

Timeline

27 December 2017

Primary endpoint
21 December 2023

21 December 2023

Quick facts

Lead sponsor	Coherex Medical
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	248
Start date	27 December 2017
Primary completion	21 December 2023
Estimated completion	21 December 2023
Sites	25 locations across United States, Australia

Drugs / interventions tested

• Coherex WaveCrest® Left Atrial Appendage Occlusion System
• Watchman® LAA Closure Device

Conditions studied

• Stroke — all drugs for Stroke →

Sponsor

Coherex Medical — full company profile →

Who can join

18 and older, any sex, with Stroke. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With Composite of All Cause Death, Procedure or Device Related Complications Requiring Percutaneous or Surgical Intervention or Major Bleeding Primary · All death, procedure- or device-related complications requiring percutaneous or surgical intervention: From baseline up to 45 days; major bleeding: From baseline up to 5 years 11 months

The primary safety outcome was the composite of death from any cause (all-cause mortality), procedure or device related complications requiring percutaneous or surgical intervention through 45 days post procedure or major bleeding throughout the duration of the trial. The analysis was based on sponsor assessment of adverse events data. Baseline was defined as 90 day prior to treatment or 90 days prior to randomization; baseline assessments could occur on the day of implant.

Group	Value	95% CI
Group 1 (WaveCrest Roll-In)	47.89	35.9 – 60.1
Group 2 (WaveCrest Randomized)	32.69	20.3 – 47.1
Group 3 (Watchman Randomized)	17.86	8.9 – 30.4

Percentage of Participants With Composite of Ischemic Stroke or Systemic Embolism at 24 Months Primary · At 24 months

Percentage of participants with composite of ischemic stroke or systemic embolism at 24 months was reported.

Group	Value	95% CI
Group 1 (WaveCrest Roll-In)	4.23	0.9 – 11.9
Group 2 (WaveCrest Randomized)	3.85	0.5 – 13.2
Group 3 (Watchman Randomized)	5.36	1.1 – 14.9

Percentage of Participants With Ischemic Stroke or Systemic Embolism With the WAVECREST Device in Comparison to the CHADS2 and CHA2DS2-VASc Imputed Risk of Ischemic Stroke or Systemic Embolism in the Absence of Anticoagulant Therapy Secondary · At 45 days

CHADS2 (congestive heart failure, hypertension, age \>=75 years (yrs), prior Stroke/transient ischemic attack (TIA)/Thromboembolism) and CHA2DS2-VASc scores (Vascular disease, Age 65- 74 yrs, female Sex) were developed to identify non-valvular atrial fibrillation (AF) participants at an elevated risk for ischemic stroke. CHADS2 score assign 1 point: congestive heart failure, hypertension, age \>= 75 yrs, diabetes mellitus; 2 points: prior stroke/TIA/thromboembolism. CHADS2 score ranges from 0 to 6. Higher scores indicated higher risk for ischemic strokes. CHA2DS2-VASc Score assign 1 point for

ischemic strokes

Group	Value	95% CI
Group 1 (WaveCrest Roll-In)	4.23
Group 2 (WaveCrest Randomized)	3.85
Group 3 (Watchman Randomized)	5.36

systemic embolisms

Group	Value	95% CI
Group 1 (WaveCrest Roll-In)	0
Group 2 (WaveCrest Randomized)	0
Group 3 (Watchman Randomized)	0

Percentage of Participants With Left Atrial Appendage (LAA) Closure Secondary · At 45 days

Percentage of participants with LAA closure, defined as a gap of \<= 5 millimetre (mm) at the 45-day visit as assessed by transesophageal echocardiogram (TEE) was reported.

Group	Value	95% CI
Group 1 (WaveCrest Roll-In)	100.0
Group 2 (WaveCrest Randomized)	100.0
Group 3 (Watchman Randomized)	100.0

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline up to 5 years 11 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Group 1 (WaveCrest Roll-In):

Serious: 50/71 (70%)

Deaths: 15/71

Group 2 (WaveCrest Randomized)

Serious: 42/52 (81%)

Deaths: 13/52

Group 3 (Watchman Randomized)

Serious: 39/56 (70%)

Deaths: 4/56

Serious adverse events (247 terms)

Reaction	System	Group 1 (WaveCrest Roll-In):	Group 2 (WaveCrest Randomi…	Group 3 (Watchman Randomiz…
Atrial fibrillation	Cardiac disorders	—	—	—
Pericardial effusion	Cardiac disorders	—	—	—
Acute kidney injury	Renal and urinary disorders	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—
Gastrointestinal haemorrhage	Gastrointestinal disorders	—	—	—
Pneumonia	Infections and infestations	—	—	—
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—	—
Cardiac failure congestive	Cardiac disorders	—	—	—
Chest pain	General disorders	—	—	—
Sepsis	Infections and infestations	—	—	—
Cardiac failure acute	Cardiac disorders	—	—	—
Mitral valve incompetence	Cardiac disorders	—	—	—
Urinary tract infection	Infections and infestations	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—	—
Syncope	Nervous system disorders	—	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—	—
Iron deficiency anaemia	Blood and lymphatic system disorders	—	—	—
Acute left ventricular failure	Cardiac disorders	—	—	—
Acute myocardial infarction	Cardiac disorders	—	—	—
Cardiac failure	Cardiac disorders	—	—	—
Coronary artery disease	Cardiac disorders	—	—	—
Cellulitis	Infections and infestations	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—

Other adverse events (29 terms — click to expand)

Reaction	System	Group 1 (WaveCrest Roll-In):	Group 2 (WaveCrest Randomi…	Group 3 (Watchman Randomiz…
Gastrointestinal disorders	Gastrointestinal disorders	—	—	—
Metabolism and nutrition disorders	Metabolism and nutrition disorders	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—
Pericardial effusion	Cardiac disorders	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—
Skin and subcutaneous tissue disorders	Skin and subcutaneous tissue disorders	—	—	—
Urinary tract infection	Infections and infestations	—	—	—
Corona virus infection	Infections and infestations	—	—	—
Acute kidney injury	Renal and urinary disorders	—	—	—
Eye disorders	Eye disorders	—	—	—
Chest pain	General disorders	—	—	—
Laceration	Injury, poisoning and procedural complications	—	—	—
Investigations	Investigations	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—
Haematuria	Renal and urinary disorders	—	—	—
Hypotension	Vascular disorders	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—
Oedema peripheral	General disorders	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—
Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Hypertension	Vascular disorders	—	—	—
Psychiatric disorders	Nervous system disorders	—	—	—
Fatigue	General disorders	—	—	—
Cellulitis	Infections and infestations	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—
Dizziness	Nervous system disorders	—	—	—
Reproductive system and breast disorders	Reproductive system and breast disorders	—	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—	—
Syncope	Nervous system disorders	—	—	—

Most-reported serious reactions: Atrial fibrillation, Pericardial effusion, Acute kidney injury, Anaemia, Gastrointestinal haemorrhage, Pneumonia, Acute respiratory failure, Cardiac failure congestive.

Data from ClinicalTrials.gov NCT03302494 adverse events section.

Sponsor's own description

The WAVECREST 2 trial is a prospective, multicenter, randomized, active controlled, clinical trial to evaluate the safety and effectiveness of the Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. The NCDR Left Atrial Appendage Occlusion Registry.
   Freeman JV, Varosy P, Price MJ, Slotwiner D, et al · · 2020 · cited 292× · PMID 32238316 · DOI 10.1016/j.jacc.2019.12.040
2. Cardiovascular Therapies Targeting Left Atrial Appendage.
   Turagam MK, Velagapudi P, Kar S, Holmes D, et al · · 2018 · cited 42× · PMID 29954658 · DOI 10.1016/j.jacc.2018.05.048
3. Stroke Prevention in Atrial Fibrillation: A Scientific Statement of <i>JACC: Asia</i> (Part 1).
   Chiang CE, Chao TF, Choi EK, Lim TW, et al · · 2022 · cited 19× · PMID 36339361 · DOI 10.1016/j.jacasi.2022.05.005
4. Left Atrial Appendage Closure: A Narrative Review.
   Nagasaka T, Nakamura M. · · 2023 · cited 8× · PMID 37938523 · DOI 10.1007/s40119-023-00337-2
5. Left Atrial Appendage Occlusion : Current Advances and Remaining Challenges
   Alkhouli M, Ellis C, Daniels M, Coylewright M, et al · · 2022